VOLUME 16 ISSUE 11 NOVEMBER 2011

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THIS MonTH...

Cover Story: Presbyopia 4 Corneal surgeons discuss the benefits and possible drawbacks of corneal inlays for presbyopia treatment

Newsmaker Interview 8 EURETInA president, Gisbert Richard, talks about future plans for the society

Cataract & Refractive 10 Looking to the future with femtosecond laser-assisted cataract surgery11 First installation of EUREQUo in Austria gets positive feedback12 Comparing results with colleagues a definite benefit for this practice13 Technique supports compromised zonules14 Study outcomes with multi-component IoL encouraging16 Prof Tassignon talks about her IoL design to help eliminate PCo

Cornea 18 Femtosecond laser for LASIK flap creation has some drawbacks19 Study shows KeraRing implantation offers minimally invasive treatment20 Amniotic membrane may have an antimicrobial effect21 Corneal inflammatory disease is a major cause of blindness

Glaucoma 22 Refractive surgery and glaucoma23 Big increase in use of aqueous shunts as primary glaucoma surgery24 Improving the outcome of glaucoma trabeculectomy procedures

Retina 26 Latest results with VEGF Trap27 Targeting tumour necrosis28 Trials show effectiveness of intravitreal injection of ocriplasmin 29 Retinal detachment visual outcomes32 Vitelliform lesions and their diagnosis

Ocular 34 Amniotic membrane advantageous in treating ocular trauma injuries35 Major advances in understanding genetics of eye disease in near future

Paediatric Ophthalmology 37 Glaucoma very difficult to treat in children, says expert

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NOVEMBER 2011Volume 16 | Issue 11

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Published byThe European Society of Cataract and Refractive Surgeons

Features 38 EU Matters39 Book Review42 out & About43 JCRS Highlights

44 Industry news46 Bio-ophthalmology48 Calendar

With this month’s issue... Take your PracTice To a New LeveL wiTh The ZeiSS MicS PLaTforM

As certified by ABC, the EuroTimes average net circulation for the 11 issues distributed between 01 January 2010 and 31 December 2010 is 32,019.

by José Güell

Has the time come for ophthalmologists to embrace the concept of corneal inlays for treating presbyopia? This is one of the questions we have attempted to answer in our Cover Story in this month's issue of EuroTimes.

I am pleased to have been invited to take part in this debate as I recognise that some of my colleagues think inlay technology may play an increasingly important role in our daily practice as cornea specialists in the future.

As Daniel Durrie points out this is not a new technology and in the 1980s there were a number of attempts to introduce corneal inlays to the market.

These were not successful but as the technology has developed and matured, more data has now become available. However, on a personal level, I would argue that we should exercise caution and we should be looking for more data with longer follow-up to assess the thorough potential of these inlays.

We need to keep an open mind on the data that has been presented so far and listen to the arguments both in favour of and against corneal inlays. Most importantly, as with all other aspects of our work, we need to be certain that these inlays are not only effective in treating presbyopia, but also that they are safe.

I also think that it is important that we debate these issues at our meetings. The XXIX ESCRS Congress in Vienna was our most successful and best attended meeting to date and one of the reasons for the continuing success of our meetings is that ophthalmologists recognised the importance of introducing new ideas and discussing the hot topics in ophthalmology with their colleagues.

In this exciting age of technological development it is possible to communicate across countries and time zones in a way that our predecessors could never have imagined. But I would argue that nothing can equal the experience of discussing our challenges and opportunities face to face. If I have a question or a problem, I may send an email to one of my colleagues but my best answers will come when we sit together in a room and share our experiences.

ESCRS success Finally, I would like to conclude this editorial by looking back at some of the highlights of our recent congress. The meeting was a towering success thanks to the excellent work of our members who helped in the organisation of the congress and the excellent support we continue to receive from the staff at Agenda.

I must also say that as president of ESCRS I was delighted to see so many old friends and colleagues attending the congress but also the new generation of ophthalmologists who attended the meeting for the first time.

This year's congress was preceded by the 2nd EuCornea Congress and the first ever Glaucoma Day organised by the European Glaucoma Society and I believe that these collaborations have helped to add a new dimension to the ESCRS Congress. Another highlight was the fundraising for two charities, oRBIS and oxfam, and I am very proud that the ESCRS has helped to ensure that the funds raised will help to improve the quality of the lives of the people who will benefit from these two projects.

of course, as one congress finishes, we start immediately to prepare for our next meeting which will be the 16th ESCRS Winter Meeting in Prague. We will then look forward to September 2012 in Milan when the ESCRS will partner with three subspecialty societies: EURETInA, EuCornea and the 2nd World Congress of Paediatric ophthalmology and Strabismus. 

As another year is nearly over, a new year will begin and I look forward in 2012 to seeing more success for ESCRS and all of those who support our society.

José Güell is president of the ESCRS .

EUROTIMES | Volume 16 | Issue 11

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EDITORIAL Volume 16 | Issue 11

editorial

OPENING OUR MINDSInlay technology may play an increasingly important role in the treatment of presbyopia

José Güell

Clive Peckar

Emanuel RosenChairman

ESCRS Publications Committee

Ioannis Pallikaris

Paul Rosen

Medical Editors

International Editorial Board

EUROTIMESESC

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Noel alpins australia

Bekir aslan turKEY

Bill aylward uK

Peter Barry irElaND

roberto Bellucci italY

hiroko Bissen-Miyajima JaPaN

John chang CHiNa

Joseph colin FraNCE

alaa el Danasoury sauDi araBia

oliver findl austria

i howard fine usa

Jack holladay usa vikentia katsanevaki GrEECE

Thomas kohnen GErMaNY

anastasios konstas GrEECE

Dennis Lam HONG KONG

Boris Malyugin russia Marguerite McDonald usa

cyres Mehta iNDia

Thomas Neuhann GErMaNY

rudy Nuijts tHE NEtHErlaNDs

Gisbert richard GErMaNY

robert Stegmann sOutH aFriCa

ulf Stenevi sWEDEN

emrullah Tasindi turKEY

Marie-Jose Tassignon BElGiuM

Manfred Tetz GErMaNY

carlo enrico Traverso italY

roberto Zaldivar arGENtiNa

oliver Zeitz GErMaNY

www.vsybiotechnology.com

by Dermot McGrath

PRESBYOPIA AND CORNEAL INLAYS

The past few years have seen a resurgence of interest in corneal inlays as a potential treatment for presbyopia. Some surgeons

have hailed the latest generation of inlay technologies as a breakthrough in the search for a universally effective and universally applicable treatment for presbyopia.

others warn that the marketing hype is running ahead of the clinical reality and that the inlay needs more hard data and longer follow-up to assess its credentials as a groundbreaking technology.

“I think we need to keep an open mind and not rush to judgment on this promising technology,” said José Guell MD, director of the Cornea and Refractive Surgery Unit at the Instituto de Microcirugia ocular, Barcelona, Spain. “We need more scientific data on both the safety and efficacy of these inlays before we start recommending them systematically to our patients. If we are talking about inducing monovision optionally in an otherwise healthy eye just to slightly enhance near vision, then I don’t think the argument is strong enough to propose that to my patients right now. But it could certainly be an interesting addition to our surgical toolkit and merits close attention as more data becomes available,” he said.

Back to the future Given the current hype surrounding presbyopic inlays, it is perhaps easy to forget that the technology has actually been around for a long time, said Daniel S Durrie MD, clinical professor of ophthalmology, University of Kansas Medical Centre, and president, Durrie Vision, Kansas, US.

“Corneal inlays for improving vision are not a new concept. Back in the early 1980s we saw several different attempts at corneal inlays for the presbyopic market that never really got off the ground for one reason or another,” Dr Durrie told EuroTimes. “What we are seeing now is the maturing of this technology, which addresses a lot of the earlier issues with the inlays, and also more clinical data and commercial results are starting to filter through, so we are seeing a new excitement about it,” he said.

Dr Durrie identified three main types of inlay that have been used over the years to try to improve vision. The first approach tried to use inlays to change the corneal curvature, and in the process alter the corneal power.

“A lot of these early attempts used materials that were not very permeable to oxygen or glucose and were difficult to do because everybody’s corneal curvature is different and it just wasn’t very accurate. So

the inlays were eventually replaced by lasers which did the job more accurately,” he said.

The Vue+/PresbyLens inlay (ReVision optics Inc), currently undergoing clinical trials in the US, uses a refined version of this approach, but changes the corneal curvature in the centre of the cornea only.

The second type of inlay sought to change the corneal power by putting a high index refraction inlay in the cornea.

“They ended up not being very permeable and the cornea biologically did not tolerate them very well, so that too was abandoned,” said Dr Durrie.

This approach has since been re-visited by two inlays: the InVue corneal inlay (originally developed by BioVision AG, later acquired by neoptics AG) which addressed the bio-compatibility issue by incorporating a pinhole in the centre of the lens that allowed nutrients to pass through, and the Flexivue Microlens (Presbia Inc.) corneal inlay which is placed in a self-sealing stromal pocket which holds the lens in place in the centre of the visual axis.

Changing the optical principles The third strategy to improve vision for presbyopes eschews changing either the power or the curvature of the cornea, but instead seeks to alter the optical principles

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PRESBYOPIAcover Story

Corneal inlays discover new lease of life as potential presbyopic treatment

EUROTIMES | Volume 16 | Issue 11

Back in the early 1980s we saw several different attempts at corneal inlays for the presbyopic market that never really got off the ground for one reason or another

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Daniel S Durrie MD

I think we need to keep an open mind and not rush to judgment on this promising technology

“José Güell MD

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The versatility of the Kamra inlays makes them a great solution for presbyopia

“Gunther Grabner MD

of the cornea using small aperture optics.This is the approach favoured by the

Kamra inlay (previously the ACI 7000, AcuFocus Inc.), which is leading the inlay pack in terms of regulatory approval and clinical follow-up, with over 5,000 implants performed worldwide and four-year data from a Turkish centre now published1.

“The versatility of the Kamra inlays makes them a great solution for presbyopia,” said Gunther Grabner MD, professor of ophthalmology and chairman of the University Eye Clinic at Paracelsus Medical University in Salzburg, Austria, noting that they have been implanted successfully in emmetropes, ametropes, monofocal pseudophakic patients and post-LASIK patients.

“In the United States clinical study of 507 patients who received the Kamra inlay, 18-month data showed that the inlay provided patients, on average, with J-2 uncorrected near acuity, 20/25 uncorrected intermediate acuity and 20/20 uncorrected distance acuity in their inlay implanted eye. Additionally, for the Kamra inlay, the mechanism of action using small aperture optics continues to work over several years without a reduction in acuity, as can happen with other power-based corneal inlays that need to be updated as the patient’s lens continues to lose accommodative function,” he said.

The inlays are also removable, allowing the patient to take advantage of future technologies for correcting presbyopia or cataract should the need arise, added Prof Grabner.

As a selling point for inlay technology, the implant’s reversibility should not be underestimated in a competitive market, according to Richard Lindstrom MD, founder of Minnesota Eye Centres, Minneapolis, US.

“The reversibility factor is certainly very attractive. If the patient doesn’t like them, they can be easily removed and no further procedure is required to restore them back to their original refractive status. I also appreciate the fact that the inlays always enhance near vision, with only a marginal loss of distance acuity depending on the inlay utilised. Because it is a monocular procedure, you always maintain quality distance vision in the other eye, which the patients seem to appreciate,” he said.

Target market In Dr Lindstrom’s view, the real target group for inlays are not so much early-stage presbyopes that occasionally need reading glasses, but rather the presbyopic population aged around 50-upwards who have become handicapped enough in their daily activities to consider alternatives to reading glasses.

While the initial expectation in the industry was that corneal inlays would hold most appeal for emmetropic presbyopes, the reality on the ground has been somewhat different, he said.

“Emmetropic presbyopes are certainly candidates but the largest number of patients who seem to ask for the surgery are presbyopes who are also myopic or hyperopic and may also have astigmatism. I see those patients in my practice every day, but understandably they don’t want to trade far glasses for near glasses. For these patients, the best solution is usually what we call SIM-LASIK, which is LASIK first to correct their ametropia and then the inlay to deal with their presbyopia,” he said.

While the demand for presbyopic treatments worldwide is on the increase, patients today are much better informed about the options open to them, said Cati Albou-Ganem MD, in practice at the Clinique de la Vision, Paris, France.

“There has been a definite shift in the age profile of the typical refractive surgery patient in recent years, from around 35 years about a decade ago to around 45 or 50 years-of-age today. These patients are looking for simple and effective solutions that can take care of their presbyopia, and I think corneal inlays will give us further options to offer more personalised solutions for these patients,” she said.

Compared to approaches such as PresbyLASIK or IntraCor, corneal inlays offer a minimally invasive, safe, reversible surgical technique for presbyopes, said Dimitris I Bouzoukis MD, Institute of Vision and optics, University of Crete, Greece

“There is no steep learning curve for the surgeon and the surgery can be performed without changing or adding new equipment or software in a modern refractive surgery theatre equipped with a femtosecond laser,” he said.

Downsides to inlay technology But even the best technology has its downsides – and corneal inlays are no exception.

“The main disadvantage is that the inlay is a reasonable but not a perfect solution for presbyopia, as only one eye is corrected,” said António Limão oliveira MD, Instituto Microcirurgia ocular in Lisbon, Portugal, who has been involved with the European multicentre trial of the Vue+ corneal inlay. “With this approach, binocularity is disturbed, at least at near, and patients become independent but not completely free of glasses for near vision,” he said. In Dr oliveira’s view, the best candidates for inlays are emmetropic presbyopes with a clear lens, 20/20 uncorrected distance vision and a near add of about +2.00 D.

“The most important exclusion criteria for the Vue+ corneal inlay is dry eye, any kind of corneal pathology, central corneal thickness inferior to 500 microns, and monovision intolerance,” he said.

Inlays may also be unsuitable for patients with very high expectations, said Dr Bouzoukis. “As with all bifocal or multifocal corrections, retinal image contrast may be reduced in eyes implanted with the Flexivue and Vue+ devices and retinal illuminance may be markedly reduced with the Kamra implant. Effects on contrast sensitivity and stereopsis have yet to be adequately explored. Regarding reversibility and safety, more studies are needed to demonstrate if the technique is really reversible with no changes to the preoperative emmetropic status of these patients, or if they are just removable, and to demonstrate that after a long follow-up they are not creating corneal alterations,” he said.

Prof Grabner said that in his clinical experience with the Kamra inlay, there was no significant reduction found in retinal illuminance for patients implanted with the inlay, and he believes that the five-year follow-up data speaks volumes for the long-term safety of the device.

“We tested the inlay and found that there was only a very slight reduction in the mean deviation visual field of 2 dB. We now have up to five years' follow-up in the first series – a time frame that seems quite reasonable to postulate that they are very safe,” he said.

Another potential problem is that not all patients adapt quickly to their post-inlay vision, said Dr Albou-Ganem. “I recently

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EUROTIMES | Volume 16 | Issue 11

FLEXIVUE MICRO-LENS Inlay Characteristics:– Acts changing the refractive index of the cornea

– Donut shape bifocal refractive power

– The lens is implanted into the stroma of the cornea on the non-dominant eye, inside a corneal tunnel created using femtosecond laser.

– The lens is “Invisible”

– Biocompatible hydrogel-based material with a central hole to increase more the nutrient flow.

– The refractive effect is pupil depended, inreasing during near vision and decreasing during far vision, changing less the far vision in the operated eye than in a classic monovision procedure

Flexivue Micro-Lens Corneal Inlay (Presbia)

IntraCor technique

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The reversibility factor is certainly very attractive. If the patient doesn’t like them, they can be easily removed and no further procedure is required to restore them back to their original refractive status

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Richard Lindstrom MD

There has been a definite shift in the age profile of the typical refractive surgery patient in recent years, from around 35 years about a decade ago to around 45 or 50 years-of-age today

“

Cati Albou-Ganem MD

EUROTIMES | Volume 16 | Issue 11

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PRESBYOPIA

cover StoryJosé Güell - guell@imo.esDaniel Durrie - ddurrie@durrievision.comGunther Grabner - g.grabner@salk.atRichard Lindstrom - rllindstrom@mneye.comCati Albou-Ganem - cati.ganem@wanadoo.frDimitris Bouzoukis - Dbouzoukis@hotmail.comAntónio Limão Oliveira - antoniolimao@imo.pt

contacts

did a LASIK procedure followed by Kamra implantation in the non-dominant eye of a myopic patient but after several days the patient was still not very comfortable with it. However, I always urge these patients to give it time because there is a process of neuro-adaptation with the inlay. It is a little bit like the IntraCor procedure in this respect – some patients have immediate results after the surgery, but sometimes it takes a few weeks for other patients to adapt to their new vision,” she said.

Centration is another potential issue with inlays, said Dr Lindstrom, and some concerns have also been raised about long-term bio-compatibility. “There can be some mild interface reaction that occurs between the implant and the cornea. I have seen some earlier generation hydrogel inlays 20 years after implantation and they look good with no visually significant scarring. But if you remove the inlay and look very carefully you can see where the implant was placed. That occurs with the Kamra inlay as well, although it does not cause visually significant light scatter or other symptoms,” he said.

Dr Durrie agrees that centration is critical for optimal functioning of the inlay,

but believes that an electronic alignment system such as that recently introduced for the Kamra inlay, effectively deals with this issue and will become the norm for optimal placement of these types of implant.

Using latest-generation femtosecond laser technology will also help to reduce variations in wound healing, said Dr Durrie.

“We found that creating the femtosecond pocket or flap atraumatically using the latest laser models resulted in faster visual rehabilitation. The key is making sure that you are using modern equipment for a smooth ablation and then there is less variability in the wound healing,” he said.

For optimal outcomes with the Presbylens/Vue+ inlay, Dr oliveira advised using disposable instruments, with careful delivery of the inlay in the centre of the pupil, without tearing it, and keeping the flap hydrated to avoid microstriae, he said.

Prof Grabner highlighted the importance of managing patient expectations and advised careful and aggressive management of dry eye pre- and postoperatively, as this population tends to have drier eyes. “other tips to get the best from the Kamra inlay are to ensure that patients follow the post-op medication regimen precisely, to target

for a little residual myopia in the inlay eye and use the AcuTarget-System to place the Kamra inlay with great precision,” he said.

Massive market potential While corneal inlays are still only in the early phases of adoption for most ophthalmic practices, that picture could change rapidly as more clinical trial data becomes available and demand for the inlays gathers momentum.

“From a business aspect, this appears to be one of those rare products that turns out to be a win-win-win situation for the patient, the doctor and the company producing it,” said Dr Durrie. “It is relatively straightforward for the company to produce, and patients tend not to mind spending a bit more money on it in order to get what they consider to be a top-of-the-line product. As doctors, we are often introduced to technologies that just increase the cost of what we are doing without really increasing the value, which is definitely not the case with corneal inlays,” he said.

[1] Ömer F. Yılmaz, et al. Journal of Cataract & Refractive Surgery Vol. 37, Issue 7, Pages 1275-128.

Don’t miss Paediatric Ophthalmology, see page 37

There is no steep learning curve for the surgeon and the surgery can be performed without changing or adding new equipment or software in a modern refractive surgery theatre equipped with a femtosecond laser

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Dimitris I Bouzoukis MD

The main disadvantage is that the inlay is a reasonable but not a perfect solution for presbyopia, as only one eye is corrected

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António Limão Oliveira MD

3.8mm diameter, opaque biocompatible polymer material, a 1.6 mm centre aperture and 8,400 random holes for oxygen and nutrition flow. Implant placed under corneal flap or in corneal pocket using proprietary guidance system

PHYSICAL PROPERTIES

The inlay’s 1.6mm centre aperture creates a pinhole effect which is designed to improve depth of focus, allowing the eye to see near and intermediate objects more clearly

MECHAnISM Of ACTIOn

CE mark. FDA trials nearing completion

REGULATORY SITUATIOn

3.0mm diameter and 15 µm to 20 µm thick microlens made of hydrophilic acrylic material

The centre of the lens has no power, but features a pinhole for nutritional purposes. Near vision is corrected by the lens’ outer rim

Technology acquired by Neoptics AG. Trials currently under way in Europe

2.0mm diameter bio-engineered, micro-porous, hydrogel material

Adds a microscopic change in curvature to the centre of the cornea of non-dominant eye to add near and intermediate focusing power

CE mark. FDA trials currently under way in the United States

3.0mm diameter refractive hydrophilic polymer lens placed in a corneal stromal pocket using FS laser

The lens’ central zone is free of refractive power with a standard positive refractive power in the peripheral zone

CE mark

Kamra

InLAY

AcuFocus Inc.

COMPAnY

InVue BioVision AG

Vue+ ReVision Optics Inc.

flexivue Microlens

Presbia Coöperatief U.A.

©Eurotimes. Data compiled from industry sources

(1) Slit lamp photo of a Vue+ inlay well centred in the pupil (2,3) Animated eye representing the Vue+ inlay

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www.medicontur.com

THE FIRST

HYDROPHOBIC LENS WITHOUT

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Q: How did you first become involved in

EURETInA?The goal of EURETInA from the beginning was to organise research, scientific exchange and clinical education not just nationally but Europe-wide. In the beginning, however, this was a rather small group. After a congress in Hamburg, August Deutman (netherlands), Jean-Jacques De Laey (Belgium), Gisèle Soubrane (France), Krystyna Pecold (Poland) and myself (Germany), sat together in the Hamburg Ratskeller and decided to establish EURETInA. Within a short time, Borja Corcóstequi (Spain), José Cunha-Vaz (Portugal) and Bill Aylward (England) joined us. It was a small nucleus of friends, who coordinated very well and cooperated with one another and who idealistically followed the aim of leading EURETInA to success. This led to the founding of the society and to its registration in Hamburg, Germany. In the first eight years I had the honour to serve the society as general secretary and the good fortune to have presidents who identified with the idea and who, each in his own way, made EURETInA what it is today, a leading institution in vitreoretinal research, training and education worldwide.

Q: Have the goals of EURETInA changed as

the society has evolved?The goals have not changed, but the methods to reach these goals have developed. our goal has always been to bind together important and active personalities from different countries

to EURETInA, in particular those who dedicate themselves to retinology research themes, are clinically and operationally successful and who play an important political role in their countries. An important step in the further development of our society was developing our association with Agenda Communications, who undertook the organisation of the industrial exhibitions and even the congresses professionally and reliably. Another important step was the presentation of the society by journals and publications, at first through EuroTimes, and later through the acquisition of the journal Ophthalmologica as the scientific journal of EURETInA. In the last few years we have also had an online journal (EURETInA-brief), which is sent regularly to our members and other interested parties.

Q: Has taking on the reins as president of

EURETInA provided you with additional insights into the role the society should play in enhancing retinal research in Europe?

one of the society’s duties will be to represent a crystallisation point for retina research in Europe. This research will not only be undertaken by ophthalmologists, but also by numerous basic scientists in the fields of biology, neurology, whose scientific findings will be of interest for use in the clinic. For this reason we have established a yearly winter meeting of EURETInA, which for the next two years will take place in Rome and will provide a platform for the exchange of views between researchers from basic science and clinicians.

Q: What are some of the emerging controversies

that EURETInA may need to address in the immediate future?Europe has many excellent researchers and clinicians working in the field of the retina and vitreous body. They are, however, under-represented in the European institutions. Therefore, it makes sense to play a lobbying role for members at the European level and to coordinate training throughout Europe. This will involve, probably together with our American friends, setting training standards and developing guidelines.

Q: What are some of the factors that are drawing

in new members to the society and increasing attendance at EURETInA Congresses to the point where it is now one of the biggest retina meetings in the world?our goal is always to provide main sessions, educational courses and surgical skills courses of an outstanding quality. This leads to a sufficient number of satisfied participants. Although our society is still very young, very many participants already have a strong identification with EURETInA. Surveys show a high level of satisfaction among those taking part and also a very good acceptance of the basic idea.

Q: Last year in Paris, the ESCRS and

EURETInA had a joint congress and there will be another joint congress in Milan in 2012. What do you think are some of the benefits likely to accrue from the closer ties being built between the two societies and the two specialties, cataract/refractive and retinal research?our often elderly patients who require treatment of both the anterior or posterior segments of the eye and modern microsurgery can now achieve that. Moreover, modern small incision technology improves the prospects of this combined surgical procedure. Due to this background, the congress in Paris was a great success. Therefore, we believe that both meetings complement one another very well, so that both sides, as well as the industry, will profit excellently from it.

Q: How do you hope to build on the

achievement of past EURETInA presidents, during your term in that office?EURETInA has always had the good fortune to have had very active presidents, who, each in his own way, has devoted himself to our idea. This has been an important element in the development of the society, whereby the people involved always had an excellent personal relationship with each other. There was always a special “spirit” in EURETInA, supporting our idea enormously to continue this will be an important commitment for the future.

FUTURE CHALLENGESEuropean Society of Retina Specialists advancing research through collaboration

EUROTIMES | Volume 16 | Issue 11

Newsmaker interview8

EURETINA

Gisbert Richard - augenklinik@uke.uni-hamburg.de

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act

EuroTimes contributing editor, Roibeard O’hEineachain, spoke with EURETINA president, Gisbert Richard MD, about the society’s continuing evolution and its current and future goals

EURETINA president Gisbert Richard speaking at this year’s EURETINA Congress in London

PRAGUE 201216TH ESCRS WINTER MEETING

3-5 FebruaryHilton Prague Hotel

www.escrs.org

EUROPEAN SOCIETY OF CATARACT & REFRACTIVE SURGEONS

In conjunction with the Czech Society of Cataract and Refractive Surgery

update

cATAracT & REFracTIVE

EUROTIMES | Volume 16 | Issue 11

Industry is betting big on the future of femtosecond laser-assisted cataract surgery. Four systems are on or near market launch and others

are in development. While all focus on automating surgical steps including peripheral corneal relaxing incisions, cataract surgical incisions, anterior capsulotomy and lens fragmentation, they vary in their imaging approaches, corneal interfaces and power delivery algorithms. Form factors for ease of use and portability also vary. Below are the four systems that are furthest along.

LenSx With numerous clinical installations around the world and US FDA approval for cataract incisions, relaxing incisions, anterior capsulotomy and lens fragmentation, LenSx is arguably the current market leader. The system consists of a femtosecond laser with an integrated proprietary oCT imaging system that provides real-time views of the anterior and posterior chambers, and allows surgeons to adjust cutting parameters before and during procedures. LenSx uses a disposable curved interface that docks to the eye with guidance from the onboard microscope and oCT.

Clinical trials show that the system is capable of producing nearly perfectly centred and sized capsulotomies, and reducing phaco energy required to aspirate lenses. Studies also suggest a lower deviation in effective lens position, holding out the possibility for more predictable refractive outcomes. Research on cataract incisions also shows they are less prone to leak than manual incisions.

Alcon purchased LenSx in a deal potentially worth $744m. This is not only a powerful endorsement of the economic potential of femto-cataract technology, it also backs LenSx with the market muscle of the global industry leader in cataract surgery. According to a report by Kevin M Miller MD, David Geffen School of Medicine at UCLA, Los Angeles, US, the current purchase price of the LenSx system is about $550,000. He estimates the service agreement cost at $40,000 annually after the first year and patient interface/procedure fees of $425 per procedure, though there may be volume discounts. Dr Miller presented these data at the

4th Annual International Conference on Femtosecond Lasers In Technology (ICFLo) at Monarch Beach, Dana Point, California, US, June 24-25 2011.

OptiMedica With CE mark received in August and worldwide launch anticipated this year, optiMedica’s Catalys Precision Laser System is a product of more than six years of development. The system’s most distinctive features include its novel patient interface and automated 3-D treatment customisation with spectral domain oCT.

After initial clinical tests revealed that a curved applanation interface can produce folds in the posterior cornea, optiMedica developed the Liquid optics™ interface. According to CEo Mark Forchette, this produces a more optically perfect system that enhances imaging strength and prevents laser pulses from being misdirected or skipping. Additionally, the interface design minimises intraocular pressure rise.

Catalys’ Integral Guidance™ system combines proprietary oCT and automated 3-D treatment customisation. Sophisticated algorithms process the oCT to accurately map the relevant ocular surfaces in 3-D and build exclusion zones to prevent laser energy from penetrating the posterior capsule or other tissues. To minimise the

time that a patient is under suction, the treatment plan is automatically customised based on imaged anatomy and safety zone margins.

Clinical trials show that Catalys dramatically improves the precision of several key surgical steps. It produces capsulotomies that are within 30 microns of intended size, within 80 microns of intended centre and exhibit near perfect circularity. Lens fragmentation with Catalys has also demonstrated an approximate 40 per cent reduction in CDE.

Long known for its retinal lasers, including the highly regarded PASCAL photocoagulator, optiMedica sold its retinal product line to Topcon Corp. last year to focus on Catalys. The sale price, service agreement terms and patient interface/procedure fees have not been determined, though Dr Miller projects that a laser cost in the range of $450,000 and per procedure costs of $400 are reasonable expectations.

LensAR originally conceived to restore accommodation by softening the crystalline lens using femtosecond laser energy, LensAR has been developed for cataract applications and is now FDA approved for anterior capsulotomy and lens fragmentation. Rather than oCT, LensAR uses an integrated

3-D confocal-structured laser illumination imaging system based on the Schiempflug principle, which the firm says gives the system greater depth of focus and improves imaging of higher-grade cataracts. The laser and the optical system are aligned in the same path allowing precise placement of the laser shots. It uses a BSS fluid, non-corneal contact, non-applanating suction device to eliminate distortion of the eye’s anatomy, allowing for more accurate treatment and beam delivery. The device is also compact and wheeled, with an articulating treatment arm that can move in any direction, making it suitable for use within the operating suite in a temporal or superior approach according to physician preference.

over 550 eyes have been treated with the LensAR system, and it has been used in extensive trials to develop nucleus fracturing patterns, including cubes and swirls. With appropriate algorithms, cataracts up to grade five have been removed with significantly reduced phaco energy. LensAR also has been shown to produce uniform anterior capsulotomies, cataract incisions and limbal relaxing incisions with great precision. The 3-D-CSI’s high fidelity low noise images provides the resolution necessary for automated software to work, giving the surgeon the choice of exact capsulorhexis location and incision placement without manually placing cursors on the image.

While no LensAR systems are clinically available yet, Dr Miller estimates the purchase price at about $400,000, service agreements at $40,000 annually after the first year, and procedure fees of $150 for capsulotomy and $200 for relaxing incisions.

Technolas Perfect Vision The femto-cataract procedure is TPV’s latest advancement for its femtosecond laser platform technology. It incorporates real-time oCT for planning and monitoring procedures, and features the firm’s custom Curved Patient Interface combined with Intelligent Pressure Sensors to minimise corneal distortions.

Trials led by Gerd Auffarth MD, University of Heidelberg, Germany, in collaboration with Kasu Prasad Reddy MD, Hyderabad, India, and Luis Antonio Ruiz MD, Bogota, Columbia, show that the system is capable of producing capsulotomies more precisely than manual, and laser lens fragmentation reduces the phaco energy required. Corneal arcuate incisions have already been available for use with the TPV femtosecond laser platform for a number of years.

The combination of refractive and cataract procedures on a single platform is a key selling point of TPV’s laser. The firm has announced it will be marketed worldwide and an FDA application is pending for US approval.

LenSx: Sandra Waite - sandra.waite@cibavision.comOptiMedica: Rob Eno - reno@optimedica.comLensAR: Nick Curtis - nick.curtis@lensar.comTechnolas Perfect Vision:

Lindsay Brooks - l.brooks@technolaspv.comKevin M Miller - kmiller@ucla.educo

ntac

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FEMTOSECOND LASERSFour systems are on the market or close to launchby Howard Larkin

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While all focus on automating surgical steps including peripheral corneal relaxing incisions, cataract surgical incisions, anterior capsulotomy and lens fragmentation, they vary in their imaging approaches, corneal interfaces and power delivery algorithms

CatalysTM Precision Laser System Technolas Femtosecond Laser Workstation

EUROTIMES | Volume 16 | Issue 11

The first major installation of the European Registry of Quality outcomes for cataract & refractive surgery (EUREQUo) in Austria

has provided highly useful performance improvement data with minimal administrative burden, Britta Luebke MD told the XXIX Congress of the ESCRS. Recording more than 4,500 cases in its first year, the implementation of EUREQUo at the Hospital of St John of God in Linz is one of the largest to date outside the pilot programmes launched in Scandinavia, The netherlands and Spain in 2009.

St John of God joined EUREQUo in April 2010, Dr Luebke said. As in other European countries, quality control is becoming a major focus of health policy in Austria. She believes participating in EUREQUo will not only help surgeons to improve clinical outcomes, it will also help the hospital to demonstrate its capability compared with surgeons throughout Europe. It also helps meet quality monitoring requirements set e.g. by the International organization for Standardization (ISo) or the European Foundation for Quality Management (EFQM).

Dr Luebke said that collecting data for EUREQUo is relatively easy, taking about 60 seconds for surgeons to dictate, and another two minutes for clerical staff to enter it into the computer.

In the first year of participating St John of God reported 4,568 of a total of 5,144 cases logged on EUREQUo in Austria. This is about 90 per cent of the Austrian cases and three per cent of the total of 153,806 cases reported throughout Europe in this period. Because the majority of the cases in Austria came from St John of God, Dr Luebke compared outcomes with the broader European database. A few differences were noted.

St John of God showed higher rates of age-related macular degeneration (AMD) in cataract patients, about 23 per cent compared with about 13 per cent for all of Europe. Also higher rates of pseudoexfoliation, 3.7 per cent compared to 0.5 per cent in Europe have been diagnosed.

These results suggest that the preliminary clinical investigation in the hospital of St John of God is performed at an above-average level. Topical anaesthesia could not be compared, because not all countries hand in information about the type of anaesthesia they use. Inpatient surgery is, with 52 per cent, more common at St John of God than in Europe, with only 2.4 per cent most likely due to organisational and financial reasons.

St John of God used more hydrophobic acrylic intraocular lenses, 99.9 per cent compared with 83 per cent, and had with -0.48 D a lower mean biometry target refraction compared with the European mean of -0.26 D. Use of colourless lenses was higher in St John, 70 per cent compared with 50 per cent in Europe, and aspheric lens use lower, 1.5 per cent compared with 30 per cent in Europe overall. Surgical complication rates were broadly similar, though St John of God reported little lower posterior capsule rupture rates, but higher vitreous loss rates, probably due to the circumstance, that cataract operations in St John of God are mainly performed by vitreous surgeons and an anterior vitrectomy is performed without hesitation.

overall, Dr Luebke believes EUREQUo is well worth the effort. The database allows ophthalmic surgeons to monitor their own outcomes, and provides perspective through comparing aggregate results from all other participating centres in their own country and in Europe. This facilitates clinical audits and quality improvement, and enables surgeons to track changes in daily practices, such as use of yellow, aspheric or toric lenses. “Quality is good. It benefits everyone,” Dr Luebke said.

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COMPARING DATAFirst implementation of EUREQUO in Austria provides vital benchmarking databy Howard Larkin in Vienna

update

cATAracT & REFracTIVE

Quality is good. It benefits everyone“

Britta Luebke MD

Don’t miss Industry News, see page 44

Technolas Perfect Vision GmbHMesserschmittstr. 1 + 380992 München, Germanywww.technolaspv.com

*Technolas Perfect Vision data on fileSome of the products and/or specic features as well as the procedures featured in this document may not be approved in your country and thus may not be available there.Design and specications are subject to change without prior notice as a result of ongoing technical development. SUPRACOR is NOT approved for use in the US. SUPRACOR is not approvedin all countries. Please contact our regional representative regarding individual availability in your respective market. The trademarks (™ and ®) and logos used in this document are theproperty of Technolas Perfect Vision GmbH or the respective owner. Design by kbcomunicacion. Ref. TPV-068/09-2011©2011 Technolas Perfect Vision GmbH. All rights reserved.

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Participation in EUREQUo, the European Registry of Quality outcomes for Cataract and Refractive Surgery, provides

cataract and refractive surgeons with a clear indication of how their results compare with their colleagues in their own country and throughout Europe, said Camille Budo MD, Sint Truiden, Belgium.

“EUREQUo is the first step towards developing the exchange of information and experience on good practice. It takes about one minute to complete the forms requested by EUREQUo and can be done by a technician. Then, one can objectively measure the quality of one’s own surgery by comparing your results with those of colleagues in your own country and throughout Europe,” Dr Budo said at the 15th ESCRS Winter Meeting, where he presented the findings of his first year of participation in the EUREQUo project.

The participating surgeon or their technician provides data regarding a range of parameters, mostly by checking off boxes or using drop-down lists as indicated. The data requested starts with the gender of the patient, whether they had previously undergone cataract surgery, and the name of the surgeon, he noted.

Additional data includes the presence of other eye diseases in general and also in particular those which tend to involve complicated cataract surgery, such as previous refractive surgery, white cataracts, corneal opacity, small pupils or pseudoexfoliation.

“The most important preoperative parameters are visual acuity and the presence and axis of astigmatism, factors which vary between centres and could have a bearing on results,” Dr Budo said.

Intraoperative parameters include whatever complications may have occurred

during surgery, such as capsular rupture and vitreous loss. Postoperative parameters include visual acuity and astigmatism findings. The parameters for multifocal and accommodative lenses include for near intermediate and far categories.

“You can compare your results with different IoLs with those obtained by colleagues in your country or across Europe, and you can also compare your corneal and retinal complications.”

Country-wide and Europe-wide comparison To illustrate how the EUREQUo registry can enable surgeons to gauge the quality of their surgery, Dr Budo presented a summary of his own centre’s results during its first year of participation in EUREQUo and their comparison to the average findings in centres in Belgium and throughout the 12 European countries currently participating in the EUREQUo project.

The registry data showed that 71.6 per cent of patients treated for cataract at the Sint Truiden clinic had a preoperative uncorrected visual acuity better than 5/12, Dr Budo noted. That compared to a national average for Belgian centres of 62.35 per cent and an average of 39.05 per cent for the entire EUREQUo registry.

The data also showed that there were no co-existing eye diseases in about 82.72 per cent of cataract patients treated at Dr Budo’s centre, in 72.22 per cent of those treated in Belgium, and in 65.58 per cent of those treated in Europe.

All cataract patients treated at the Sint Truiden clinic underwent phacoemulsification and implantation of a posterior chamber IoL, as did 99.38 per cent in Belgium and 99.12 per cent in Europe, Dr Budo said.

Another finding was that surgery was judged as “not difficult” in 98.77 per cent of patients treated at Dr Budo’s centre, in 88.27 per cent of patients treated in Belgium and in 90.74 per cent of patients treated in Europe.

Dr Budo noted that the main type of IoL used at the Sint Truiden centres during the year under study was a hydrophilic acrylic lens, used in 88.89 per cent of eyes. However, that is because in that year the centre was involved in a trial with that lens, he said. Their current first choice is a hydrophobic

lens, which was also the type of lens used for 48.15 per cent of cataract procedures in Belgium and 90.87 per cent in Europe, he added.

Topical anaesthesia was used in all procedures in the Sint Truiden centre and 82.1 per cent of procedures in Belgium but only 5.32 per cent of procedures Europe-wide, he said.

At Dr Budo’s centre, cataract surgery was uneventful in 98.77 per cent of cases, as was the case in 97.53 per cent of cases in Belgium and 98.49 per cent of cases throughout Europe. The rate of posterior capsular rupture was 1.23 per cent (one out of 81 patients) in the Sint Truiden clinic, 0.62 per cent (one out of 162 patients) of Belgian cases and 1.31 per cent (1511 out of 115,694 patients) of cases in the EUREQUo registry.

Postoperative uncorrected visual acuities were 6/6 or better in 37.04 per cent of eyes at the St Truiden clinic, 25.93 per cent in Belgium and 20.25 per cent throughout Europe. In addition, the proportion with visual acuity below 6/12 was 9.88 per cent at Dr Budo’s centre, 10.49 per cent throughout Belgium, but 26.71 per cent throughout Europe.

Best-corrected visual acuities were roughly similar in the different groupings. That is, around half of patients, in Sint Truiden, in Belgium and in Europe achieved 6/6 and around 70 per cent to 80 per cent achieved 6/7.5.

Dr Budo suggested that the addition of a few additional parameters could enhance the value of the EUREQUo registry. For example, when recording details concerning eyes that had undergone previous refractive surgery, the inclusion of the IoL calculation formula used would enable their comparison over wide groups of patients, he said.

Similarly, in eyes that are undergoing implantation of a toric IoL, the inclusion of the techniques used for preoperative marking the axis of cylinder and postoperative axis alignment could also be useful for comparison. That would also make it possible to compare different toric IoLs in terms of their postoperative rotation, Dr Budo added.

EXCHANGING INFORMATIONFirst experiences with EUREQUO registry show the system provides good assessment of surgical quality

EUROTIMES | Volume 16 | Issue 11

Camille Budo - budo@skynet.be

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Joint IRISH and UKISCRS Refractive Surgery Meeting

Friday 9th March 2012Croke Park Conference CentreDublin

Dermot Pierse Memorial Lectureand Tom Casey Memorial Lecture

Grand Round

Topics

KeratoconusPresbyopiaCataract ComplicationNew IOL Design

Further Details from:Helen MurphySecretary to:Prof. Michael O’KeeffeSuite 5, Mater Private Hospital,Eccles St., Dublin 7.Tel:(00 353 1) 885 8626Email: hmurphy@materprivate.ie

Registration Fees:

Euro €200 Sterling £170

Special Hotel Rateat the Croke Park Hotel(opposite the conference centre)

by Roibeard O’hEineachain in Istanbul

update

cATAracT & REFracTIVE

The most important preoperative parameters are visual acuity and the presence and axis of astigmatism, factors which vary between centres and could have a bearing on results

“

Camille Budo MD

EUROTIMES | Volume 16 | Issue 11

In eyes with an intact vitreous face, a subluxed lens can be safely removed and an IoL implanted in the capsular bag without any disruption of the

vitreous, but in cases of dropped nuclei, a thorough vitrectomy is the safest option, according to presentations at the 11th EURETInA Congress.

Som Prasad MS FRCophth, FRCSEd, FACS, Arrowe Park Hospital, Wirral, UK noted that in the past surgery for a subluxed lens has involved disruption of the vitreous, through intracapsular surgery or pars plana lensectomy. However, this approach carries with it a high risk of retinal detachment, ranging in different series from eight per cent to 38 per cent. In addition, the anterior chamber lenses generally used in such cases are particularly unsuitable for Marfan syndrome patients - who make up the bulk of patients with ectopia lentis - because of the unusual anatomy of their corneas and angles.

For those reasons, Dr Prasad recommended a technique involving the use of iris hooks to facilitate creation of the capsulorhexis, a capsular tension ring to stretch and stabilise the capsule during lens removal, and capsular tension segments sutured to the sclera to serve as support for areas of zonular weakness. “This technique allows consistent placement of an IoL into a well-centred and secure capsular bag without disruption of the vitreous.” Dr Prasad’s technique involves first creating a 3.0mm by 3.0mm scleral pocket using a limbal incision. He then uses two or three iris hooks to secure the capsulorhexis as he creates it, drawing the bag to a central position as he completes the rhexis. After performing the hydrodissection, using short pulses of fluid to avoid unnecessary pressure on the capsular bag, he inserts the capsular tension ring and proceeds with the phacoemulsification or lens aspiration using a biaxial approach.

once he has removed the lens material from the eye, Dr Prasad takes the capsular tension ring segment and passes a 10-0 prolene suture through its central islet using an Ethicon CIF-4 needle. He then injects a dispersive ophthalmic viscosurgical device to simultaneously create a space between the iris and the capsular bag and tamponade the vitreous face.

Afterwards, he places the capsular tension segment into the capsular bag to provide

support for the area of greatest zonular deficiency. He then draws the needle between the iris and the anterior capsule, bringing it out 1.5mm behind the limbus and through the scleral pocket created at the beginning of the procedure. After adjusting the tightness to achieve the best centration of the bag, the knot slides into the scleral pocket and with a secure bag he places the IoL within the bag, with haptics positioned in the standard way.

“The fact that surgery can be completed without loss of vitreous and minimal traumas potentially decreases the risk of future retinal problems. This has encouraged us to offer surgical intervention at an early stage to patients with lens subluxation in Marfan syndrome.” Cases where the nucleus enters the vitreous represents a completely different situation and efforts of conservative management have a high risk of failure and future complications, said Ferenc Kuhn MD, University of Alabama at Birmingham. Birmingham, Alabama, US.

“Removal of the entire vitreous and all lost lens particles reduces the risk of continual inflammation with all its consequences such as cystoid macular oedema and retinal detachment,” he said.

An immediate vitrectomy has the advantage of preventing inflammation arising from the presence of the dropped nucleus in the vitreous. It will therefore also prevent any secondary complications that might arise from an extended period of intraocular inflammation.

Dr Kuhn added that under ideal circumstances the vitrectomy should be performed immediately, if possible, by a trained vitreoretinal surgeon. It will also prevent unnecessary anxiety on the part of the patient. He said that it is best to remove all of the vitreous, including the posterior cortical vitreous. The vitrectomy probe is also an effective instrument for removing the lens cortex. He added that he prefers to complete the vitrectomy before he tackles the nucleus.

He noted that in cases where the nucleus is only slightly or moderately large and hard, it is usually possible to break the nucleus into smaller pieces using the light pipe and the vitrectomy probe. A phacofragmentor is only necessary in the cases with very hard nuclei. Moreover, in some cases it is possible to remove large nucleus fragments through the limbal incision.

Dr Kuhn said he concludes such cases by performing a 360-degree retinopexy. He added that the use of this approach has reduced the rate of retinal detachment following dropped nuclei from over eight per cent to under one per cent. Dr Kuhn

also emphasised that when choosing how to deal with dropped nuclei, cataract surgeons should keep in mind that what looks good at the conclusion of the procedure may still result in complications later on that require the attention of a vitreoretinal surgeon.

Som Prasad - sprasad@rcsed.ac.ukFerenc Kuhn - fkuhn@mindspring.com

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DISPLACED LENSESVitrectomy often avoidable with subluxed lenses but not with dropped nucleiby Roibeard O’hEineachain in London

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Figure 1: A scleral pocket is created without conjunctival dissection. A 550 micron incision is made in peripheral clear

cornea (similar to a limbal relaxing incision), and a crescent blade is then used to dissect a pocket in the sclera, 3mm x 3mm

Figure 3: The rhexis is completed after iris hooks have engaged the rhexis and drawn the bad to a relatively central position

Figure 5: Bimanual irrigation aspiration is used to remove lens matter in this soft lens in a young patient. If the lens is hard we

prefer a biaxial microincision strategy (BMICS)

Figure 7: As the 10-0 prolene suture is tightened, judging bag centration, the knot buries itself into the scleral pocket

Figure 2: ‘Iris’ retractors are preplaced poised to secure the capsulorrhexis as it is developed. The first retractor is being used

to engage the rhexis. Note that the rhexis has been developed for a few millimetres beyond the point of engagement to avoid

misdirection as the rhexis edge is torn further

Figure 4: A CTR is inserted, this stretches and stabilises the bag facilitating further manoeuvres

Figure 6: Once the bag is empty a CTS is guided in to support the area of maximum zonular deficiency

Figure 8: The IOL had been inserted into the bag which is well centred. The CTS is visible. The Scleral suture is buried into the

scleral pocket with no visible ends

update

cATAracT & REFracTIVE

update

cATAracT & REFracTIVE

EUROTIMES | Volume 16 | Issue 11

A recent study with the new multi-component IoL (Infinite Vision optics) demonstrates that the primary and enhancement

surgeries with this novel system are feasible, safe and result in promising clinical outcomes, reported Dimitra Portaliou MD, at the XXIX Congress of the ESCRS.

The multi-component (two elements) IoL is a foldable posterior chamber ocular system designed to allow customised correction of all degrees of sphere and cylinder along with multifocality, and with the opportunity for customised adjustment at any time post-surgery. The Infinite Vision optics (IVo) lens system is an adjustable, two lens system which differs from conventional piggyback lenses in that the lenses are attached one to the other; one lens (the base lens) is situated in the capsular bag, the second lens (the front lens) sits in front of the capsular bag, and whose optics are totally separate, one from the other (Figures 1a, 1b, 2a, 2b). In the study, six patients who received the IoL ranged in age from 47 to 82 years. They underwent routine cataract surgery in procedures performed by Ioannis Pallikaris MD, PhD, at the Institute of Vision and optics, University of Crete. one patient in the series received a cylindrical front component IoL, and one patient (out of the study) underwent enhancement surgery at nine months after the primary procedure to correct residual refractive error. The enhancement procedure was performed through the same incision created in the primary surgery.

After follow-up of two years, the visual acuity results were good (no patients received a custom prescription at the time of the primary surgery). Mean decimal distance UCVA improved from 0.08 ± 0.06 (range 0.05 to 0.2) to 0.56 ±0.02 (range 0.2 to 0.8). Mean decimal distance BCVA improved from 0.26 ± 0.13 (range 0.1 to 0.5) to 0.83 ± 0.16 (range 0.6 to 1). In the patient who underwent enhancement, refractive error improved from +2.25 D to +0.25 D, and final UCVA was 20/20.

Safety evaluations showed no patient lost any lines of BCVA. There were no intraoperative or postoperative complications, and the IoL remained centrally located in the capsule, with good clearance between the anterior optic and the iris.

“The primary objectives of this study are to demonstrate the ability to implant and assemble the multi-component lens and to perform lens exchange, as well as to evaluate its intraocular performance, focusing on the phenomenon of interlenticular fibrosis, which is a major concern with implantation of a piggyback-type lens system. our experience shows the initial implantation and enhancement procedures are easy and safe, and that interlenticular fibrosis has been avoided for greater than two-year follow-up observation,” said Dr Portaliou, research fellow, Institute of Vision and optics.

“Although our study was not designed to evaluate refractive outcomes, our data also show that this novel lens is providing excellent long-term visual outcomes similar to that achieved after any conventional cataract/IoL implantation surgery.”

The multi-component IoL is comprised of a base lens and an anterior lens. The base lens has a plate haptic configuration, sits in the capsular bag analogous to a standard posterior capsule lens, and allows for sphere corrections only. The anterior lens can be removed or exchanged at any time after surgery and  consists of any refractive combination of sphere, cylinder or multifocality.

“It is well known that no primary cataract

or refractive surgery will ever be 100 per cent accurate due to errors in biometry, the effects of pre-existing or induced astigmatism, and the unpredictable influence of the wound healing response and capsular contraction/fibrosis which can extend over a several month time period. The Infinite Vision optics IoL allows for adjustments in the immediate postoperative period to achieve the desired refractive target. Moreover, since vision is a dynamic phenomenon, this lens also allows for adjustment in the long-term to accommodate the ever changing clinical condition of patients, including the development of presbyopia or of intolerance of multifocality,” Dr Portaliou said.

“With the opportunity for long-term adjustment, this technology may also be the answer that paediatric ophthalmologists have been waiting for to address developmental age-related changes in the refractive status of the eye after infantile cataract surgery. Another long-term problem that can be addressed is that which is created when a multifocal implanted eye develops AMD. With the IVo lens system, the multifocal component can be exchanged for a more suitable optical element in the face of AMD. Furthermore, it may provide a system for intraocular drug delivery, serving as a renewable platform, slowly

releasing drugs used in the management of acute and chronic conditions, and solving medication compliance issues.”

Dr Portaliou demonstrated the implantation and assembly procedure with a video. The base lens is inserted through a 2.8mm incision into the anterior chamber and then rotated by 90 degrees into the capsular bag. Then, the front lens is injected into the anterior chamber, rotated by 90 degrees and attached to the base lens by inserting its haptics through openings in “bridges” on the face of the base lens.

“Capsule capture” is performed to avoid interlenticular fibrosis and facilitate enhancement surgery. In this technique, the anterior capsule is positioned between the haptics of the front lens and the base lens so that the front lens sits in front of the anterior capsule.

“Since the first case series were performed, there have been advances in the surgical technique, especially in instrument design. now the lenses can be easily injected and manoeuvred inside the capsule,” noted Dr Portaliou.

Another advantage of the multi-component IoL is that it dramatically reduces IoL inventory needs. Dr Portaliou explained that when implanting a single element IoL, surgeons would need to stock almost 4,000 different lenses to cover all of the possible combinations of sphere powers between -10 and +40 D (in 0.5 D steps), cylinder up to 6 D (in 0.5 D steps), and multifocality that would meet the needs of 100 per cent of the population. If a surgeon performs 10 procedures a day, the necessary inventory would need to be five times greater.

“The importance of having a full inventory of IoL options has taken on greater significance recently because of the necessity of having available a complete inventory of lenses at the time of surgery for a customised prescription, such as would be required with newer technologies like intraoperative aberrometry. With this multi-component lens technology, the needs of 100 per cent of the population could be fulfilled with just 140 lens parts, which is a manageable inventory,” Dr Portaliou said.

Several new areas of investigation are under way. Because the IVo lens system has two components, the spherical power of the implant can be divided between the two components. By halving the spherical power, the thickness of the lens components can be significantly reduced, thus allowing the possibility of a much smaller incision size, Also because of the manageable inventory size, for a truly custom prescription, the possibility exists for dioptric increments of 0.25 D, not 0.50. This would make the theoretical accuracy of the IVo lens even greater than that of glasses or contacts.

Dimitra Portaliou - mimi24279@gmail.com

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OUTCOMES ENCOURAGINGMulti-component IOL study shows surgical ease, safety and efficacyby Cheryl Guttman Krader in Vienna

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for Preliminary Programme visit www.escrs.org

XXX Congress OF THE ESCRSMilan

8-12 September

2012

15 March 2012

Deadline: Abstract Submission

update

cATAracT & REFracTIVE

EUROTIMES | Volume 16 | Issue 11

In this year’s Binkhorst Medal Lecture presented at the XXIX Congress of the ESCRS, Marie-Jose Tassignon MD, PhD, focused on novel

intraocular designs to reduce or eliminate posterior capsule opacification.

Prof Tassignon noted that from the earliest days of intraocular lens (IoL) implantation Harold Ridley identified posterior capsule opacification (PCo) as one of the most difficult problems in the treatment of cataracts. She pointed out that while YAG laser capsulotomy can ameliorate the problem to some degree it rarely restores vision to its level of acuity prior to the laser treatment.

“Posterior capsule opacification not only disturbs the transparency of ocular tissue but also changes the position of the IoL within the eye. our research has shown that YAG-laser capsulotomy reduces higher order aberrations but not to the level immediately after the primary cataract surgery,” Prof Tassignon said.

Research into PCo has focused on the barrier effect of sharp optic edges. However, recent research has shown that the complication is partially dependent on the material used, and it may be that some materials produce a greater fibrotic reaction than others.

Prof Tassignon noted that the bag-in-the-lens IoL, which she designed, takes all those factors into account and the proof of the theory behind the lens can be seen in the results she and others have obtained with it.

PCO-preventing haptic design The design of the lens requires the surgeon to perform both an anterior and posterior capsulorhexis. The grooved haptics of the lens grasp the remaining periphery of the anterior and posterior capsule and thus prevents contact between the lens epithelial cells and the IoL material, thereby preserving the capsule’s elasticity. Moreover, by pressing the two sides of the capsule together, it deprives the cells of anywhere to grow, preventing PCo.

She pointed out for example that in a comparative study, none of 100 eyes implanted with a bag-in-the-lens IoL required YAG laser capsulotomy at any point during follow-up. In contrast, eyes that had conventional in-the-bag

lenses made of the same material had a cumulative incidence rate of nd:YAG posterior capsulotomy of approximately two per cent at one year, increasing to approximately 28 per cent at 42 months (Leysen et al, J Cat Refr Surg 2006; 37: 2085-2090).  

“The visual axis remained perfectly clear with the bag-in-the lens-IoL, but decreased over time with the conventional IoL composed of the same biomaterial. The reason we have no proliferation of lens epithelial cells is because the anterior and posterior capsule merge at this area of the groove and form a fibrotic plug that is very solid,” she explained.

Furthermore, in a study involving 807

eyes implanted with the lens, including patients with a range of co-morbidities such as diabetes, glaucoma and paediatric patients, the rate of PCo has remained at zero among 350 eyes with a follow-up ranging from 12 to 84 months.

The findings of the study also confirm those found in her early laboratory studies with the lens, as well as in a pathology study involving post-mortem eyes with the lens (Werner et al, J Cat Refr Surgery 2008; 34: 2163-2165).

“The periphery of the bag at the level of the zonular fibres is untouched, the visual axis is perfect. There is a development of a Soemmering’s ring but it remains far away from the visual axis,” Prof Tassignon said.

New tools and lens designs Prof Tassignon noted that for the best results with the lens, both the anterior and posterior capsulorhexis must be well-centred, and have the right shape and diameter for the resulting capsule edges to fit securely into the haptic grooves. To assist in the manoeuvre, Prof Tassignon has designed a new flexible, ring-shaped calliper which, when placed on the anterior capsule, serves as a guide to facilitate optimal capsulorhexis creation.

There is also now a toric version of the lens for highly astigmatic eyes, which she noted has proved very stable in its position (J Cat Refr Surg 2011; 37:830-834). She added that she centres the IoL based on the patient’s pupillary entrance using Purkinje reflexes of the surgical microscope light. The primary rotational misalignment of the toric bag-in-the lens IoL can be fine tuned postoperatively.

Prof Tassignon has also experimented with accommodative version of the bag-in-the-lens IoL, using an accommodative ring that fits into the groove of the bag and between the anterior and posterior capsule and which has the same modulus of elasticity as the capsular bag. However, despite its promising design the lens did not afford the expected amount of accommodation.

She noted that she has also developed a technique for implanting the lens in eyes with poor capsule support that involves lassoing the lens to the sclera through the use of special bean-shaped rings positioned in the grooved haptics of the lens.

Finally she noted that removal of the bag-in-the-lens IoL is very easy, and that is a feature that makes it very useful for paediatric eyes, which may require lens exchange as their eyes grow. 

Marie Jose Tassignon - Marie-Jose.Tassignon @uza.be

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BINKHORST MEDAL LECTUREMarie-José Tassignon invented an IOL design which she discussed at the lectureby Roibeard O’hEineachain in Vienna

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The Binkhorst Lecture is named in honour of the late Cornelius Binkhorst, a leading figure in the field of ophthalmology who in his time left a lasting imprint on his chosen field of endeavour, not least in his central role in the founding of the European Intraocular Implant Council, which was later to become the ESCRS.

“Our research has shown that YAG-laser capsulotomy reduces higher order aberrations but not to the level immediately after the primary cataract surgery”Marie-Jose Tassignon MD, PhD

Marie-Jose tassignon with EsCrs President José Guell after she received the Binkhorst Medal at the XXiX Congress of the EsCrs Opening Ceremony

Marie Jose Tassignon - Marie-Jose.Tassignon @uza.be

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EUROTIMES | Volume 16 | Issue 11

cORNEAupdate

There are many advantages of using a femtosecond laser for LASIK flap creation, but it does not overcome all of the issues associated with

mechanical microkeratomes, Joseph Colin MD told the 2nd EuCornea Congress.

Dr Colin, chairman, Department of ophthalmology, Bordeaux University Medical School, reviewed the differences in characteristics of flaps created using a femtosecond laser and mechanical microkeratome and their safety profiles. He concluded that while mechanical microkeratomes can create high-quality flaps, results from a number of studies establish the superiority of the laser for creating better quality flaps with more predictable thickness and smoother stromal beds. In addition, the femtosecond laser creates flaps with a more desirable, planar morphology compared with a mechanical microkeratome, which enables better positioning to reduce risks of epithelial ingrowth and striae formation.

The laser also offers greater customisation. Hinge location can be varied, which can be helpful in some eyes, flap shape can be oval, which may decrease resection of corneal nerves, and side-cut angulation can be bevel-in, which has the potential to improve flap stability and decrease epithelial ingrowth.

“Benefits for improved flap geometry and for limiting many intraoperative flap complications of mechanical microkeratomes have contributed to the increased popularity of femtosecond laser LASIK. In addition, outcomes data show that relative to eyes with a mechanical microkeratome flap, femtosecond laser flap eyes have less loss of low contrast visual

acuity, and, in most studies, less induced high order aberrations. Better clinical outcomes have reduced enhancement rates and help offset the cost of the laser,” said Dr Colin.

“However, our experience and others’ show, there are still some safety issues. As reported by Moshirfar et al, while the femtosecond laser and mechanical microkeratomes differ in their complication profiles, with major epithelial defects and dislocated flaps more common using mechanical microkeratomes, and the laser being associated with more diffuse lamellar keratitis (DLK), the total complication rate is similar. In addition, an advantage for reducing the incidence of epithelial ingrowth with the laser has not yet been corroborated by clinical evidence. While thin-flap LASIK (sub-Bowman’s keratomileusis) helps preserve stroma and so may reduce the incidence of corneal ectasia, it seems to be associated with an increased incidence of interface haze.”

Discussing the safety of femtosecond laser flap creation, Dr Colin noted that a study by Michael Knorz MD, showed improved flap adhesion with femtosecond laser-created flaps having a bevel-in side cut. However, using the ocular Response Analyzer (Reichert) to measure corneal biomechanical properties, Dr Colin and colleagues found no differences in corneal hysteresis or corneal resistance factor values between eyes with bevel-in femtosecond laser versus mechanical microkeratome flaps.

Intraoperative problems associated with the mechanical microkeratome that can still occur using the femtosecond laser include suction loss leading to an incomplete flap

and creation of an irregular flap. However, with an incomplete laser flap, the procedure can usually be completed with a second laser pass at the same thickness level, and an irregular flap is very rare, occurring particularly in eyes with a previous corneal scar. Management for this complication involves creating a thicker flap at a later time using a mechanical microkeratome.

DLK also still occurs with the femtosecond laser and seems to be more common than with mechanical microkeratomes. However, according to two published studies, the risk of epithelial ingrowth is greater after an enhancement procedure (~ two per cent) and is extremely rare using the femtosecond laser in primary femtosecond laser LASIK (incidence zero per cent and 0.3 per cent).

“In one study, the risk of clinically significant ingrowth was especially increased if the flap lift was after three or more years. So in this situation, surface ablation with or without mitomycin-C may be preferred for retreatment,” Dr Colin said.

Unique intraoperative issues accompanying use of the femtosecond

laser include opaque bubble layer (oBL), anterior chamber bubbles and epithelial breakthrough. oBL, a collection of gas bubbles in the intralamellar spaces above and below the resection plane, may make flap lifting more difficult, impede some excimer laser trackers and possibly change the rate of tissue ablation, resulting in some induced astigmatism. Bubbles in the anterior chamber occur very rarely and also interferes with infrared pupil trackers. In these eyes, the surgery can proceed without active pupil tracking or after waiting a few hours for the bubbles to disappear.

Epithelial breakthrough, in which gas bubbles break through the epithelium within the flap margin prematurely, has an estimated incidence of 0.1 per cent and is most likely if the flap thickness is programmed to be 100 microns or less or in eyes with a focal break or scar in Bowman’s membrane. However, in most cases the flap can still be lifted and the ablation performed safely.

Unique postoperative complications of femtosecond laser flap creation include transient light sensitivity (TLS) in which patients develop photophobia two to six weeks after an uneventful procedure, and rainbow glare, where patients perceive a spectrum of coloured bands radiating from a white light source in darkness.

“Rainbow glare is not serious, but it can cause complaints from patients who expect perfect results,” Dr Colin said.

Results of a retrospective safety analysis including 1200 consecutive eyes that underwent femtosecond laser LASIK at Bordeaux University show the rate of intraoperative and postoperative flap complications was similarly low (~0.7 per cent). Intraoperative complications included two cases each of anterior chamber gas bubbles interfering with laser pupil tracking and premature breakthrough of gas bubbles through the epithelium, three incomplete flaps due to suction loss, and one irregular flap in an eye with a previous corneal scar. Six eyes developed DLK, which was stage three to four in two eyes, and there were three cases of TLS.

Joseph Colin - joseph.colin@chu-bordeaux.fr

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FEMTOSECOND LASERLaser for flap creation affords numerous benefits, but also trades some old problems for newby Cheryl Guttman Krader in Vienna

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In one study, the risk of clinically significant ingrowth was especially increased if the flap lift was after three or more years

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Joseph Colin MD

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EUROTIMES | Volume 16 | Issue 11

KeraRing implantation using a femtosecond laser offers a minimally invasive treatment with good biocompatibility and

a low rate of complications in patients with keratoconus, according to a study presented at the 2nd EuCornea Congress.

“In this small study we observed no complications in our patients and there was no modification of cell density in the central cornea and no modification of the epithelium, anterior stroma and endothelium around the rings, which indicates that the implant seems to be well tolerated by the ocular tissues,” said Thomas Gaujoux MD, Department of ophthalmology at the Quinze-Vingts national ophthalmology Hospital in Paris, France.

Dr Gaujoux said, however, that the study team did observe an increase in keratocyte density in the mid and posterior stroma area surrounding the ring segments, suggesting possible keratocyte activation and compressed stromal layers.

Dr Gaujoux’s study included nine eyes of keratoconus patients that were prospectively examined with the HRT 3 confocal microscope using the Rostock cornea module (Heidelberg Engineering) immediately before intracorneal ring implantation (KeraRing, Mediphacos) and again at six months and one year after implantation. Imaging software was used to analyse epithelial basal cell density, endothelial cell density and keratocyte density in the anterior, mid and posterior stroma and around the ring segments.

Eligibility criteria for the study included patients with at least grade two keratoconus, as denoted using the Krumeich classification system, clear central cornea, minimal pachymetry of more than 400 microns, and contact lens intolerance.

A 150-kHz femtosecond laser was used to create precise tunnels and the KeraRing PMMA segments were manually implanted to 70 per cent corneal depth. In terms of design, the KeraRing implants are characterised by a triangular cross-section that induces a prismatic effect by which the light coming through the implant is reflected, reducing the incidence of glare and haloes. Their apical diameter is 5.0mm and the flat basis width is 0.6mm with both

variable thickness and arc lengths. The optical zone provided by the ring segments is 5.0mm in diameter and depending on the case, one or two KeraRing segments of the same or different sizes may be implanted.

Looking at the overall results, Dr Gaujoux said that confocal images of the central basal cells one year after implantation showed no modification in the morphological structure of the central cornea. nor was any modification found in endothelial cell density in either the central or peripheral cornea. In terms of keratocyte density, there was no modification of keratocyte density in the central cornea or the anterior stroma. However, the study authors did note an increase of keratocyte density in the mid and posterior stroma, as well as intrastromal deposits of unknown provenance, which increased over time.

“These intrastromal deposits are interesting but their clinical significance remains to be established. We are not sure about the composition of this material, which is perhaps some form of lipid substance or cholesterol crystals, but we do know that they increase over time and the long-term consequences are unknown,” he said.

Dr Gaujoux said that a longer follow-up with a larger series of patients would help to confirm the findings of this initial study.

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IMPLANTATIONKeraRing shows good biocompatibility in French study but longer follow-up is neededby Dermot McGrath in Vienna

Thomas Gaujoux - Thomasgaujoux@yahoo.fr

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Confocal image of intracorneal ring segment

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MILAN6 - 7 September 2012

www.eucornea.org

3rd EuCornea Congress

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EUROTIMES | Volume 16 | Issue 11

Amniotic membrane has many qualities that make it attractive for ocular surgery. It provides trauma protection with

little immune response; it encourages epithelialisation of damaged cornea and conjunctiva, and suppresses inflammation, neovascularisation and cicatrisation, which helps keep recovering corneas clear and ocular tissues free of obstructive scar tissue or abnormal blood vessels. It may even have an antimicrobial effect.

As a result, amniotic membrane has been used in a long list of ocular procedures. It is particularly useful for grafting and patching epithelial ulcers and defects, protecting the epithelium following PK, limbal transplants, treating partial limbal deficiency, reducing calcium deposits in band keratopathy and after corneal EDTA treatment, and for immediate treatment of chemical burns. It also has been successfully used to culture corneal limbal epithelium for transplant.

“I think we all consider it a part of our standard surgical armamentarium,” ESCRS president Jose Guell MD, Barcelona, Spain, told the second annual EuCornea Congress.

However, the mechanisms of action of amniotic membrane are poorly understood, Dr Guell noted. As a result, “I honestly believe it is currently being used far in excess of its true useful potential.”

For example, it is not suitable in cases of complete limbal deficiency, should not replace conjunctival grafts for pterygium, is not a useful patch for pseudophakic corneal oedema and cannot be substituted for corneal stroma, he said. While it has been used to suppress scar formation in glaucoma filtering surgery, its track record is poor in these applications.

“I think we need to take into account these limitations.”

Mechanisms of action Derived from donor tissue from the amniotic sac, amniotic membrane was used experimentally as far back as the 1940s, and was used clinically in ophthalmology beginning in the early 1990s. In 1995

it became more widely available as preservation problems were overcome.

Dr Guell pointed out that some of the mechanisms of action for amniotic membrane are inferred from its composition rather than proven scientifically in relation to ocular surgery.

“We all thought preserved membrane to be an inert tissue with no viable cells and with very low biological activity.”

nonetheless, different parts of the amniotic membrane have different properties with implications for surgical applications. The epithelium has the highest concentration of growth factors and is the best substratum for culturing limbal cells of undifferentiated epithelial phenotype. Consequently, the membrane is typically placed epithelium side up in cases where rapid epithelium is desirable.

The basal lamina, which remains after any type of preservation, is made up of collagen, laminin and fibronectin similar to the conjunctiva. It promotes epithelial cell

migration, strengthens adhesions to basal cells, induces epithelial differentiation, and prevents apoptosis.

The stromal matrix suppresses inflammatory signalling factors, traps inflammatory cells from other tissues and induces their rapid apoptosis, and contains anti-inflammatory and anti-angiogenic proteins and protease inhibitors. It reduces inflammation locally, and is effective in treating inflamed tissues. Stromal side-up transplants remain clear.

Surgical strategies As a graft, amniotic membrane can replace absent stromal matrix and provide a basement membrane for epithelial growth, Dr Guell said. As a patch, it protects the ocular surface from external insults and provides biological factors to reduce inflammation and promote epithelialisation. In combination, epithelial side-up membrane at the periphery covered by stromal side-up at the centre ensures that epithelial cells

migrating from the conjunctiva will grow only at the periphery rather than growing over the cornea, as can happen with a single membrane.

There are many indications for amniotic membrane as a corneal graft, the most common being persistent epithelial ulceration and bullous keratopathy, Dr Guell said. He cautioned, however, that simply using membrane as a patch has only a temporary effect on bullous keratopathy. It may improve the epithelium, but after a few months the bullli reappear. All of the diseased epithelium must be removed and the membrane used as a patch to support conjunctival epithelial growth. As a corneal graft in combination with a corneal patch, it also can be used to treat neurotrophic ulcer.

The most common indication for amniotic membrane is as a patch, Dr Guell said. It is very effective for persistent corneal endothelial defects and promoting epithelialisation after PK in older and diabetic patients.

“We can improve early post-op epithelialisation. In a case with perforation we use all of our weapons, PK, membrane, and Avastin, to improve the behaviour of the eye. In eyes where we do limbal transplantation we also use the membrane to protect the epithelial surface.”

In a keratoconic eye, Dr Guell has used amniotic membrane to improve epithelialisation after scraping the epithelium. For partial limbal deficiency after extended contact use amniotic membrane can be used to encourage regrowth.

“It does not make sense to use membrane on complete limbal deficiency because the membrane will not afford limbal cells.”

For acute chemical calcification, amniotic membrane can control inflammation and allow re-epithelialisation if it is applied within a few hours of the injury, Dr Guell said. But typically, patients don’t come for two or three weeks, and then it is too late.

Culturing limbal cells from a fellow eye for transplant is a new indication. Dr Guell believes more will emerge as research progresses. He suggested that a group be formed to compare studies and standardise evaluation of ocular surface disease, such as the number of clock hours of limbal deficiency.

“our understanding of the best method of preservation for the membrane and its mechanisms of action still needs significant research.”

José Güell - guell@imo.es

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AMNIOTIC MEMBRANEMany ocular applications; research needed to define limitsby Howard Larkin in Vienna

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cORNEAupdate

Harminder Dua and Jose Guell speaking at the 2nd EuCornea Congress in Vienna

Don’t miss Bio-ophthalmology, see page 46

EUROTIMES | Volume 16 | Issue 11

The imaging capabilities of anterior segment optical coherence tomography (AS-oCT, Visante, Carl Zeiss Meditec Inc) allows for

objective, in-vivo assessment of microbial keratitis and effective monitoring of the disease course, according to a presentation at the 2nd EuCornea Congress.

“AS-oCT can be used for in-vivo quantification of bacterial keratitis and provides us with an objective assessment of corneal inflammation and treatment response with serial examinations,” said Aris Konstantopoulos MSc, MRCophth.

Dr Konstantopoulos, an ophthalmologist at Southampton University Hospitals nHS Trust, UK, noted that corneal inflammatory disease is a major cause of blindness, as the infection and inflammation can lead to scarring, melting and perforation.

“Bacterial keratitis is a serious corneal infection with at least 4,000 cases of contact lens wearers requiring hospital treatment every year in the UK alone,” he said.

The typical pathologic features of bacterial keratitis include epithelial ulceration followed by stromal inflammatory infiltration and the development of corneal oedema as

the disease progresses. With slit-lamp examination, it is possible to measure epithelial defect dimensions including infiltrate dimensions and hypopyon height, said Dr Konstantopoulos. nevertheless, assessment of the depth and extent of pathologic features is subjective and depends significantly on the experience of the examiner. “It is difficult using this approach to form a quantitative assessment of the corneal oedema, and while we can partially assess the conjunctival/episcleral injection, we can’t actually grade it,” he said.

Given the drawbacks of slit-lamp analysis, Dr Konstantopoulos and Dr Parwez Hossain, consultant ophthalmologist and senior lecturer at the University of Southampton, set out to determine if anterior segment oCT, which has been successfully used to analyse the architecture of clear corneal incisions after cataract surgery and to assess the depth of intrastromal corneal rings in keratoconic eyes, might provide a more objective assessment of corneal inflammation.

“This relatively new imaging modality provides us with non-contact cross-sectional scans of the cornea and the anterior segment and has very good penetration through

opaque structures that develop in the cornea. It also incorporates software for the measurement of pathology or structure of the anterior segment,” he said.

Because of its non-contact examination, it may be an ideal method for evaluating and monitoring corneal ulcers that are suspected to be microbial in origin, he added.

Dr Konstantopoulos’s study set out to compare corneal inflammation between Gram-positive and Gram-negative pathogens in 18 bacterial keratitis patients. After clinical diagnosis of keratitis was confirmed using corneal scrapes, all patients were treated with intensive cefuroxime and ofloxacin drops. Clinical examination and AS-oCT scans were conducted on presentation and days three, seven and 14 of treatment. 11 patients were found to have Gram-negative pathogens and seven had Gram-positive pathogens.

Cross-sectional AS oCT scans were carried out at all visits through the same area of the corneal infiltration, with the scanning beam running through the meridian that crossed the centre of the infiltration, he said.

“In using AS oCT to assess corneal inflammation, the three key parameters that we looked at in this study were corneal

thickness, infiltrate thickness, and infiltrate width,” he said.

overall, the results showed that Gram-negative pathogens induced more corneal inflammation than Gram-positive bacteria. The corneal inflammation decreased rapidly within three days of treatment and differences in infiltrate thickness and corneal thickness between pathogen groups became non-significant after the three-day treatment mark, said Dr Konstantopoulos.

While the small patient numbers limited the significance of the study, he said that data from a larger series also supported the conclusion that gram-negative pathogens induce a larger inflammatory reaction.

“The intense inflammatory reaction observed with AS-oCT is consistent with the clinical picture of the more destructive disease of pseudomonas. We also have the findings from animal studies of bacterial keratitis that show that it is predominantly polymorphonuclear neutrophil infiltration that characterises these infiltrates and that corneal oedema is proportional to corneal ingress of these neutrophils,” he said.

Summing up, Dr Konstantopoulos said that AS-oCT examination could be used for objective in-vivo quantification of bacterial keratitis, that Gram-negative pathogens induce more corneal inflammation than Gram-positive bacteria and that corneal inflammation decreases rapidly within three days of treatment. Responding to a question from John Kanellopoulos MD on whether the study might justify the use of corticosteroids in the management of infectious keratitis, Dr Konstantopoulos said further study was needed before making any such recommendation.

Aris Konstantopoulos - ariskons@yahoo.com

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INFLAMMATORY DISEASEBacterial keratitis is a serious corneal infection with large numbers requiring hospital treatment by Dermot McGrath in Vienna

21

 

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GLAUcOMAupdate

Virtually every type of refractive surgery can have effects on glaucomatous pathology and/or its diagnosis, said Stephan

Kaminski MD, Medical University of Vienna, Vienna, Austria.

“Close collaboration between refractive and glaucoma surgeons should be considered in patients who are at risk for the disease,” Dr Kaminski told attendees at a session of the special Glaucoma Day portion of the XXIX Congress of the ESCRS.

He noted that most patients undergoing refractive surgery range in age from their mid-20s to around 50 years of age. Therefore, most will have undergone their procedures at an earlier age than patients usually develop glaucoma. The prevalence of glaucoma increases with age, from two per cent in those over 40 years of age to more than 10 per cent in those over 75

years of age. Refractive surgeons have no way of knowing whether their patients will develop the disease in the future, he said.

It therefore makes good sense to closely examine a refractive surgery candidate’s ocular parameters related to glaucoma, such as optic nerve head and IoP. Patients who are at a higher risk of the disease may warrant closer scrutiny. This includes patients with a family history of the disease, those of African descent, high myopes, those with a central cornea thickness less than 500 µm, and those with cardiovascular disorders. Their examinations should include visual field testing, nerve fiber imaging and optic disc photographs, he noted.

“Most highly myopic patients have an abnormal disc and it’s really hard to detect if they have glaucomatous pathology or if it’s just due to the myopia,” Dr Kaminski said.

Refractive surgery can raise the risk The different forms of refractive surgery have the potential to damage ocular structures in ways that have an effect on parameters important in glaucoma. For example, the suction produced by a microkeratome or femtosecond laser head during LASIK can temporarily raise IoP to 80 mmHg, which might be enough to induce some vision loss in a patient with an already compromised optic nerve.

“LASEK might be a better option in eyes with suspicious nerve heads,” Dr Kaminski said.

Meanwhile, both iris-fixated and angle-supported phakic IoLs can cause synechiae and pigment dispersion, Dr Kaminski said. Angle-supported IoLs can also compromise the trabecular meshwork. Posterior chamber IoLs also carry some glaucomatous risk, as they can compromise aqueous flow and induce pigment dispersion.

With clear lens extraction the main glaucoma-related risk comes from the postoperative elevated pressure caused due to retained viscoelastic. on the other hand, such procedures may actually be beneficial in eyes with pigment dispersion glaucoma.

The IOP challenge The main problem with corneal refractive techniques in relation to glaucoma is that they can skew the findings of Goldmann applanation tonometry, which remains the gold standard, Dr Kaminski noted. LASIK in particular makes the cornea softer and flatter. Corneal inlays may also alter cornea’s biomechanics, although there is currently little data as to how it affects Goldmann applanation tonometry.

“Previous corneal refractive surgery makes it difficult to set a target IoP. Target pressure must be individualised and based on the level of IoP at which glaucomatous change occurred. Preoperative IoP may be a guide to correct for corneal changes,” Dr Kaminski said.

The use of steroids in all refractive surgical procedures, especially corneal

surface ablation procedures, carries with it a risk of IoP increase. Elevated IoP can cause fluid accumulation in the LASIK flap interface, which can be misinterpreted as diffuse lamellar keratitis, potentially leading to the prescription of further steroids, Dr Kaminski said.

Dr Kaminski cited a study of 13 eyes with suspected diffuse lamellar keratitis that received steroids to treat the condition. Subsequent tonometry showed that the mean central IoP was 19.1 mmHg but the mean peripheral IoP was 39.5 mmHg. Closer examination showed interface oedema with interface fluid pockets. Fortunately, cessation of steroid use and initiation of anti-glaucomatous therapy resulted in clear corneas and normal vision by the end of follow-up (Galal et al, J Refr Surg 2006; 22: 441-447).

However, another report showed a less favourable outcome in six eyes of four patients with diffuse lamellar keratitis treated with steroids. All eyes developed interface fluid pockets and IoP was low to normal centrally in all eyes. However, IoP was not measured in the periphery until several months after the initiation of steroid medication. By that time, three eyes of two patients had severe optic neuropathy (Hamilton et al, Ophthalmol 2002; 109:659-665).

In summarising, Dr Kaminski said that the detection of high IoP after corneal refractive procedures could be difficult. Patients should therefore have a medical records card with preoperative data like IoP, central corneal thickness, anterior chamber depth, he suggested. Patients should undergo several IoP measurements preoperatively. General ophthalmologists and glaucoma specialists also need to be aware of any refractive surgery a patient has undergone.

“Patients should inform every ophthalmologist that refractive surgery has been performed, patients are often forgetting,” Dr Kaminski concluded.

REFRACTIVE SURGERYRefractive procedures carry some risk of glaucoma misdiagnosis

EUROTIMES | Volume 16 | Issue 11

Stephan Kaminski - stephan.kaminski@ meduniwien.ac.at

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ORGANIZING SECRETARIAT: Ph. +39 06 35.49.71.14 • info@jaka.it - www.jaka.it

pubb_sitrac_Layout 1 29/07/11 13.58 Pagina 1

by Roibeard O’hEineachain in Vienna

Patients should inform every ophthalmologist that refractive surgery has been performed, patients are often forgetting

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Stephan Kaminski

Don’t miss Calendar, see page 48

GLAUcOMAupdate

Stephan Kaminski - stephan.kaminski@ meduniwien.ac.at

EUROTIMES | Volume 16 | Issue 11

Recent years have seen a marked swing away from trabeculectomy in favour of aqueous shunts as primary glaucoma surgery in

many American and European centres, a trend that is likely to continue in the future, according to Keith Barton MD.

“There has been a greater than fourfold increase in the use of aqueous shunts in recent years, even though the current devices on the market are still based loosely on a 40-year-old design. This surgical area has really suffered from a dreadful lack of investment over the years but that is now being addressed and it is very likely that future shunts might be very different from current practice,” Dr Barton told delegates attending the World Glaucoma Congress.

Dr Barton, glaucoma service director at Moorfields Eye Hospital, London, noted the irony of discussing the expanding role of drainage devices in the context of a symposium on innovation, given that the technology underpinning current shunt models dates back to the 1960s.

“Most of our drainage devices today are based on the concepts of Tony Molteno who realised that if you took a long tube and diverted aqueous, not to the limbus but to the equatorial sub-conjunctival space, that you could establish drainage with a device that worked in the longer term. The more popular devices today such as the Ahmed Glaucoma Valve (new World Medical), which has a flow restrictor, and the Baerveldt shunt (Abbott Medical optics), are really based on the original Molteno design so things have not really evolved as much as we might have hoped in the last 40 years,” he said.

Looking at the US Medicare reimbursement data for the years 1995 to 2004, which showed the number of aqueous shunting devices implanted rose by 184 per cent in that period, Dr Barton said it was not clear to what extent this rise was due to an expanded role for drainage devices.

“This might account for some of the increased use of these devices, but it might also be because of surgeons following the traditional role for shunts more consistently and more often,” he said.

Looking at this ‘traditional’ role in more detail, Dr Barton noted that glaucoma drainage devices are usually indicated in eyes where there is an established poor

record of trabeculectomy success.“This includes single chamber eyes,

anterior chamber proliferative conditions, silicone oil cases, multiple filtration surgery failures, and other types of conjunctival scarring such as previous buckle surgery. We are all familiar with the demands of these particular eyes, and the 5FU filtering surgery study in 1996 confirmed how pointless it is to perform a trabeculectomy in these eyes because the success rate is so low. These are the eyes in which an aqueous shunt probably has a better outcome,” he said.

There were also other mitigating factors that helped to act as a brake on more widespread adoption of Molteno-type drainage devices, said Dr Barton. “The use of the Molteno device was limited quite a lot because many surgeons were only doing one or two a year and found it very difficult to get the flow rate just right because it was not titratable, it required complete occlusion and it carried a high risk of hypotony. Long-term success was also limited by plate encapsulation, which was influenced by factors such as plate material, shape, thickness, rigidity and so forth. Last but not least, there was a long-term risk of corneal endothelial cell loss, influenced by previous damage and tube position,” he said.

nevertheless, some of these drawbacks were also undoubtedly dependent on surgical experience and technique, said Dr Barton, who made an analogy with the introduction of phacoemulsification in cataract surgery.

“Those of us who practised in the early 1990s and earlier will remember how phaco was first received very poorly and was regarded as a very dangerous technique. What changed that perception was partly the evolution of the equipment and technology, but also experience with the technique and knowing how to do it properly. Many of us in the past did so few of these aqueous shunt procedures that we never really built up the necessary experience. Slowly increasing experience has made it safer, with risks such as corneal endothelial cell loss greatly reduced thanks to more careful surgical technique,” he said.

Dr Barton said that several important scientific studies have provided evidence that supports primary drainage implant surgery as a reasonable approach. In this

respect, he cited Dr M T Britt’s 1999 study of the Baerveldt device which went a long way to “dispelling the myth that tubes could not achieve a low target pressure”, and the five-year results of the Tube Versus Trabeculectomy (TVT) study, in which tube shunt surgery showed a higher success rate compared with trabeculectomy using adjunctive mitomycin C in patients who have undergone previous glaucoma or cataract surgery.

The widespread perception that the TVT study involved lower-risk patients than have traditionally received tube shunt also needs to be put in context, said Dr Barton.

“This was an expansion of traditional indications and these patients had previous cataract surgery or one previous trabeculectomy failure rather than loss. However, they were not all clear corneal phacoemulsification cases. If you examine the data, only 12 per cent were clear corneal phacos and all the rest were either previous trabeculectomy failures or conjunctival cataract surgery. At enrolment the mean deviation and visual field loss was -16 dB so these were actually quite bad glaucoma cases,” he said.

Another important trial, the Ahmed Baerveldt comparison study, showed that the average IoP after one year was slightly higher in patients who received an Ahmed Valve compared to the Baerveldt device, but that there were fewer early and serious postoperative complications associated with the use of the Ahmed Valve compared to the Baerveldt, said Dr Barton.

Finally, Dr Barton said that a clearer picture should hopefully emerge from the primary TVT study, which is currently enrolling patients who have not yet had ocular surgery and have low-risk glaucomas such as primary open-angle glaucoma (PoAG), pigmentary glaucoma and pseudoexfoliation glaucoma.

“The potential benefits of the study include much cleaner comparisons as most studies include a mixture of various types of indication for surgery, so it is hard when you have an individual patient to extrapolate the results of a mixed study for that particular patient,” he said.

Drainage devices find increasing role in glaucoma surgeryby Dermot McGrath in Paris

23

         

GLAUCOMA SURGERY

Visit our new website http://youngophthalmologist.escrs.org

Young Ophthalmologists’Resource Centre

The ESCRS has developed a grant programme to support European trainee ophthalmologists who wish to observe clinical practice in a hospital or university setting.

The society is currently seeking interest from centres willing to offer observerships of one-to-two weeks’ duration in cataract and/or refractive surgery.

Those centres wishing to participate will be added to a database of centres available on this website.

to fi nd out more about the new ESCRS Observership Programme.

Keith Barton - bartoneyespa@gmail.com

contact

EUROTIMES | Volume 16 | Issue 11

A single intracameral injection of the anti-VEGF agent, bevacizumab (Avastin, Genentech/Roche), can improve

the outcome of glaucoma trabeculectomy procedures and reduce the subsequent need for postoperative interventions, according to the results of a study presented by Ingeborg Stalmans MD, PhD, Katholieke Universiteit Leuven, Leuven, Belgium, at the XXIX Congress of the ESCRS.

The randomised controlled study showed a complete success rate of 83 per cent among patients who received the anti-VEGF agent compared to only 59 per cent among patients who received placebo (p=0.003), she noted. The number of needlings required to reach the target pressure was significantly higher in the bevacizumab-treated group compared to the placebo-treated group.

“The take home message is that a single intracameral injection of bevacizumab at the end of trabeculectomy was associated with increased absolute success rates and a reduced need for postoperative interventions,” Dr Stalmans said.

In the randomised study, patients receiving bevacizumab included 37 with primary open angle glaucoma (PoAG) and 33 with normal-tension glaucoma. Patients receiving placebo included 36 with PoAG and 35 with normal tension glaucoma. Mean (treated) preoperative IoP was 21 mmHg in the PoAG patients and 15 mmHg in the normal tension glaucoma patients. All were scheduled for trabeculectomy at the time of recruitment. Patients were excluded from the study if they were pregnant, had undergone previous intraocular surgery, or had severe heart disease, untreated brain cancer, or inflammatory bowel disease.

Patients with PoAG underwent trabeculectomy with bevacizumab or placebo. Those with normal-tension glaucoma underwent trabeculectomy with mitomycin C and bevacizumab or placebo. Dr Stalmans and her associates administered bevacizumab as a single injection at a dosage of 50 microlitres, 25 mg/ml into the anterior chamber through a hydrated paracentesis.

The researchers deemed patients to be absolute successes if they achieved target

pressures without the use of IoP-lowering medications, and they deemed them to be qualified successes if they achieved target pressures with IoP-lowering medications. The fixed target pressures were 6.0 mmHg to 18 mmHg for PoAG patients and 6.0 mmHg to 14 mmHg for patients with normal-tension glaucoma.

overall absolute success was 83 per cent in patients receiving bevacizumab compared to 59 per cent in the placebo group (p=0.003). There were no significant differences between the bevacizumab groups and placebo groups in term of qualified success rates, which were, respectively, 99 per cent and 94 per cent overall, 100 per cent and 94 per cent in the PoAG patients, and 97 per cent and 94 per cent in the normal-tension glaucoma patients. The results were the same when success was defined as achieving the predetermined target IoP based on the surgeon’s clinical judgment instead of fixed target pressures.

Ingeborg Stalmans - ingeborg.stalmans @med.kuleuven.be

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ANTI-VEGF Study shows better trabeculectomy outcomes in patients receiving intracameral bevacizumabby Roibeard O’hEineachain in Vienna

GLAUcOMAupdate

The take home message is that a single intracameral injection of bevacizumab at the end of trabeculectomy was associated with increased absolute success rates and a reduced need for postoperative interventions

“

Ingeborg Stalmans MD, PhD

12th EURETINA Congress

6-9 September 2012

www.euretina.org

Abstract Submission Deadline:15 March 2012

EUROTIMES | Volume 16 | Issue 11

The efficacy, safety and tolerability outcomes for intravitreal VEGF-Trap Eye 2mg (aflibercept; Eylea, Regeneron/Bayer) injected

every two months are clinically equal to intravitreal ranibizumab 0.5mg (Lucentis, Genentech) injected monthly for the treatment of exudative age-related macular degeneration (AMD), reported Ursula Schmidt-Erfurth MD, at the annual meeting of the Association for Research in Vision and Ophthalmology.

Dr Schmidt-Erfurth, professor and chair, Department of Ophthalmology, Medical University of Vienna, Austria, presented results from the VIEW 1 (Vascular Endothelial Growth factor Trap–Eye: Investigation of Efficacy and Safety in Wet AMD) and VIEW 2 pivotal trials. Representing the largest Phase III program ever conducted in exudative AMD, the two studies enrolled 2,457 patients with active subfoveal neovascular AMD and compared three dosing regimens of VEGF-Trap Eye, 0.5mg every four weeks, 2.0mg every four weeks, and 2.0mg every eight weeks, against ranibizumab 0.5mg every four weeks.

All VEGF-Trap Eye regimens began with a loading dose of three monthly injections. OCT imaging was required per protocol only quarterly in VIEW 1 (although it was often performed monthly) and monthly in VIEW 2. Over 12 months, the mean number of injections received was 7.5 in the VEGF Trap-Eye 2mg eight-week arms and

about 12.5 across all of the four-week arms (ranibizumab and VEGF Trap-Eye).

“Current therapy with anti-VEGF agents represents a dramatic advance in the treatment of exudative AMD as up to 95 per cent of patients achieve stabilised vision and 25 per cent to 40 per cent benefit with clinically relevant BCVA gains of at least three lines. However, results from several clinical trials of ranibizumab demonstrate that continuous monthly injections and monitoring is needed to achieve such good outcomes. Consequently, ‘follow-up burden’ has become a new term closely associated with anti-VEGF therapy,” said Dr Schmidt-Erfurth, principal investigator and Steering Committee chair for VIEW 2, which was performed in centres in Europe, South America, Asia and Australia.

“The results from the VIEW studies demonstrate VEGF-Trap Eye may avoid the

need for monthly intravitreal dosing and monitoring.”

She noted the benefit of VEGF-Trap Eye could be understood based on its pharmacology. VEGF Trap-Eye is a fusion protein of key domains from human VEGF receptors 1 and 2 with the Fc portion of human immunoglobulin G. It has high affinity for all VEGF-A isoforms, binding more tightly than native receptors or ranibizumab, which is a monoclonal antibody to VEGF-A. In addition, VEGF Trap-Eye blocks the activity of placental growth factor, which is also implicated in exudative AMD, and modelling studies indicate intravitreal VEGF Trap-Eye has prolonged intraocular activity versus ranibizumab, Dr Schmidt-Erfurth explained.

VIEW results The study groups were well balanced in their demographic and baseline ocular characteristics. Across all arms, mean age was about 75 years and mean baseline ETDRS BCVA was about 53 to 54 letters. By protocol, 20 per cent of patients enrolled in VIEW 2 had to be Asian. “With its multi-ethnic population, for the first time we will be able to widely generalise data from VIEW 2,” Dr Schmidt-Erfurth said.

Analyses of BCVA data showed immediate, significant and sustained increases in all treatment arms and demonstrated non-inferiority of all VEGF-Trap Eye regimens versus ranibizumab every four weeks for the primary endpoint of the proportion of patients maintaining vision (<15 letters lost from baseline) at week 52. In the intravitreal aflibercept groups, 95 per cent to 96 per cent of patients maintained vision at 52 weeks compared with 94 per cent of ranibizumab patients.

Mean letter change from baseline BCVA at week 52 was similar for patients treated with VEGF Trap-Eye 2mg q8w and ranibizumab 0.5mg q4w in both VIEW 1 (7.9 and 8.1) and VIEW 2 (8.9 and 9.1). In addition, in both studies at week 52, about one-third of

patients treated with VEGF Trap-Eye 2mg q8w or ranibizumab 0.5mg every four weeks achieved a 3-line (15 letters) or greater gain from baseline BCVA.

“A three-line gain in BCVA is a very sensitive parameter of the clinically relevant benefit of treatment and indicates the extent to which photoreceptors may be saved and function restored,” commented Dr Schmidt-Erfurth.

Analyses of OCT images showed improvements in BCVA corresponded well with morphological findings of rapid and sustained reduction of retinal oedema, but also showed there were small fluctuations in retinal thickness values from month to month even in “perfect” responders.

No new safety signals emerged for VEGF Trap-Eye in the VIEW studies. Endophthalmitis rates were 0.3 per cent among VEGF Trap Eye-treated patients and 1.0 per cent among patients receiving ranibizumab. Mortality rates were similar for the control and VEGF Trap Eye arms, and lower than expected based on age of the patient population.

“Endophthalmitis is always a concern in studies of intravitreal injections, but the rate of this complication was extremely low and balanced across all treatment groups. The same statements can be made for Anti-Platelet Trialists Collaboration events of vascular deaths, non-fatal myocardial infarction and non-fatal stroke, as well as for hypertension, which is a sensitive indicator of systemic anti-VEGF action,” said Dr Schmidt-Erfurth.

Regeneron and Bayer HealthCare are collaborating on the global development of VEGF-Trap for the treatment of neovascular AMD, central retinal vein occlusion and diabetic macular oedema. Bayer will market it outside of the US, and has submitted an application for marketing authorisation in Europe in wet AMD in June 2011. The US FDA recently accepted the drug for priority review.

Ursula Schmidt-Erfurth – ursula.schmidt-erfurth@meduniwien.ac.at

cont

act

VEGF TRAPStudy suggests treatment every eight weeks feasibleby Cheryl Guttman Krader in Fort Lauderdale

26

retinaUpdate

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EUROTIMES

The results from the VIEW studies demonstrate VEGF-Trap Eye may avoid the need for monthly intravitreal dosing and monitoring

“

Ursula Schmidt-Erfurth MD

EUROTIMES | Volume 16 | Issue 11

Intravitreal injection with a tumour necrosis factor alpha (TNFa) inhibitor appears to have no therapeutic benefit in eyes with

exudative age-related macular degeneration refractory to anti-VEGF therapy and may elicit a severe intraocular inflammatory reaction, according to the results of a retrospective study undertaken by the Pan-American Collaborative Retina Study (PACORES) Group.

Speaking at the annual meeting of the Association for Research in Vision and Ophthalmology, Erick Hernandez-Bogantes MD, reported findings based on analyses of 20 eyes treated at four centres in South and Central America between March and May of 2009. Eyes were judged as having “refractory” disease if they had no improvements in vision, angiographic leakage and subretinal and/or intraretinal fluid on OCT after receiving at least three consecutive monthly anti-VEGF injections.

Eight eyes were treated with 1.0mg of the chimeric human/murine monoclonal TNFa antibody, infliximab (Remicade, Centocor), eight eyes received infliximab 2.0mg, and four eyes were treated with a 2mg dose of the recombinant human IgG1 monoclonal TNFa antibody, adalimumab 2mg (Humira, Abbott Laboratories).

Across the three groups, baseline logMAR BCVA ranged from 0.94 to 1.58 and central macular thickness from 301 to 387 microns. After three months, there was no significant change in logMAR BCVA or in central macular thickness with any of the TNFa inhibitor regimens. No systemic adverse events occurred, and there were no ocular adverse events in the adalimumab-treated

eyes. However, severe uveitis developed in six (37.5 per cent) of the 16 infliximab-treated eyes.

Dr Hernandez-Bogantes observed that the lack of efficacy of the intravitreal anti-TNFa treatment is consistent with some existing reports, but also needs to be reconciled with other published data that would suggest a possible role. He explained that TNFa is a proinflammatory cytokine that regulates inflammation and immune cells. In addition, exudative AMD has been associated with a TNFa gene polymorphism in a Taiwanese Chinese population, and intravitreal infliximab was shown effective for inhibiting CNV in a rat model of AMD and for improving BCVA and reducing central foveal thickness in a small case series.

“The negative outcomes in our study may represent a timing issue such that the treatment was administered too late. Alternatively, perhaps there is a dose-response effect wherein CNV may be inhibited by lower doses of anti-TNFa agents, but promoted by higher doses.

“Importantly, clinicians should be aware of the potential risks described by us and others. Fortunately, all of the uveitis cases in the present series resolved with intensive topical corticosteroid therapy. However, in a recently published paper in which the PACORES Group reported on intravitreal anti-TNFa treatment for refractory diabetic macular oedema using the same doses of infliximab and adalimumab, severe uveitis developed in eight (42 per cent) of 19 eyes treated with infliximab 2mg. Five of those cases responded to topical corticosteroid therapy, but three eyes (37.5 per cent) required pars plana vitrectomy.”

Dr Hernandez-Bogantes is a vitreoretinal research fellow, Instituto de Cirugia Ocular, San Jose, Costa Rica. His mentor, Lihteh Wu MD, is principal investigator for the study.

contactsErick Hernandez-Bogantes – erick_herbog@hotmail.comLihteh Wu – lw65@cornell.edu

TUMOUR NECROSISRetrospective study finds significant risk with no functional or anatomic benefitby Cheryl Guttman Krader In Fort Lauderdale

27

retinaUpdate

Don’t miss Book Review, see page 39

“The negative outcomes in our study may represent a timing issue such that the treatment was administered too late”Erick Hernandez-Bogantes MD

EUROTIMES | Volume 16 | Issue 11

Pooled results from two Phase 3, randomised, double-masked, placebo-controlled clinical trials demonstrate that intravitreal

injection of ocriplasmin (formerly microplasmin, ThromboGenics) is safe, effective and well-tolerated non-surgical treatment for symptomatic vitreomacular adhesion (sVMA), said Pravin U Dugel MD, at the annual meeting of the Association for Research in Vision and Ophthalmology.

The pivotal Microplasmin for IntraVitreous Injection-Traction Release withoUt Surgical Treatment (MIVI-TRUST) studies were identically designed and involved the participation of 90 investigators across the US and Europe. Patients were adults with vitreomacular traction (VMT) or full-thickness macular hole (FTHM) <400 microns that in the opinion of the investigator was related to decreased visual function. The study excluded anyone with proliferative retinopathy, exudative age-related macular degeneration (AMD), retinal vein occlusion (RVO), high myopia, aphakia, vitreous haemorrhage, or vitreous opacification in the study eye.

Participants were randomised to receive a single intravitreal injection of 0.1ml placebo solution or 125 microgram ocriplasmin. The primary efficacy variable was the proportion of patients achieving resolution of sVMA at day 28 as determined by masked OCT evaluation at a central reading centre. The analysis of this endpoint showed a highly statistically significant difference favouring ocriplasmin over the placebo-treated patients. Considering a subgroup of patients without an epiretinal membrane, the rate of resolution of sVMA at day 28 among ocriplasmin-treated eyes was even higher.

Results from secondary efficacy endpoints also showed statistically significant differences favouring ocriplasmin over the control group, said Dr Dugel, a vitreoretinal specialist in private practice, Phoenix, AZ.

“The efficacy demonstrated by ocriplasmin in the Phase 3 studies is consistent with results from earlier trials, and its safety profile has been outstanding during a clinical development programme that spans 10 years and includes more than 800 treated patients,” he commented.

The ability to safely and effectively manipulate the vitreous through pharmacologic intervention with

ocriplasmin is exciting because it brings a whole new dimension to the treatment of a number of vitreoretinal diseases, he noted.

Dr Dugel said that the “collision of three major factors” creates a situation that is ripe for the use of ocriplasmin. He cited the need for agents to use in combination with anti-VEGF injections for the treatment of retinal diseases, emerging information on the role of VMA in vision-threatening retinal diseases, and advances in diagnostic imaging technology.

Despite the benefits of anti-VEGF therapy in the treatment of AMD, RVO, and DME, it is simply not sustainable to continue to administer intravitreal anti-VEGF injections as monotherapy for these chronic diseases. Thus, a search has been ongoing for combination approaches that could reduce the necessary frequency of injections, he said.

“Recent evidence suggests that VMA may have a significant role in the development of these diseases, and the possibility of using ocriplasmin in a novel approach as a combination agent is exciting. The introduction of SD-OCT has greatly improved our ability to visualise VMA and, therefore, understand the role of VMA in many retinal diseases.”

Secondary efficacy analyses showed total posterior vitreous detachment was induced in 13.4 per cent of eyes injected with ocriplasmin, while FTMH closure was achieved at 28 days in 40.6 per cent of ocriplasmin-treated eyes with FTMH.

Twice as many ocriplasmin-treated eyes compared with the controls benefited with a two-line or greater improvement in visual acuity, and a significantly higher proportion of eyes in the ocriplasmin group compared with the controls achieved a three-line or greater improvement from baseline VA.

In quality of life assessments using the Visual Function Questionnaire-25, ocriplasmin treatment was associated with greater improvements in the general vision subscale and the composite score.

Although the efficacy of ocriplasmin was impressive in the pivotal trials, the actual results with proper patient selection may be even more impressive. Dr Dugel noted there are two aspects of the study design to consider. First, not all enrolled patients had VMA and second, ocriplasmin was administered as a single injection.contact Pravin Dugel – pdugel@gmail.com

ClINICAl TRIAlSPivotal trial results positive for pharmacologic treatment of symptomatic vitreomacular adhesionby Cheryl Guttman Krader in Fort Lauderdale

28

retinaUpdate

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EUROTIMES | Volume 16 | Issue 11

Spectral domain-optical coherence tomography (SD-OCT) holds promise as a prognostic tool for patients treated for macula-off retinal

detachment (RD), according to a study presented at the 11th EURETINA Congress.

“Recent advances in imaging technologies have enabled researchers to detect ultrastructural abnormalities in the macula to histological detail and to correlate them with functional deficits. Our study showed that SD-OCT can play a role in identifying the morphological changes preoperatively and after macula-off retinal detachment repair,” said Cristina Irigoyen MD, Royal Liverpool University Hospital, UK.

While there is a 95 per cent rate of anatomical success after RD surgery, Dr Irigoyen noted that functional success is less impressive, with only 60 per cent of patients obtaining reading ability. The reasons for such incomplete visual recovery in clinically normal looking retina is not well understood.

Recent animal model studies have helped to shed light on the pathobiological factors that can influence visual recovery in patients after RD surgery, said Dr Irigoyen.

“The retinal detachment leads to photoreceptor apoptosis that occurs two to three days after the retina is detached. The remodelling of the neural retina and subretinal pathologies such as multilayering of the retinal pigment epithelium and glial scars will limit the photoreceptor recovery,” she said.

Despite progress on many fronts, Dr Irigoyen stressed that the link between molecular expression, cellular architecture and recovery of normal vision remains relatively unexplored territory.

Dr Irigoyen’s prospective interventional study included 27 eyes that underwent RD surgery for macula-off RD between July 2009 and June 2010. Visual acuity and SD-OCT examinations were performed preoperatively and at three months, six months and one year. Exclusion criteria included dense media

and pre-existing macular conditions such as AMD and diabetic maculopathy, she said.

The aim of the study was to identify the morphological changes preoperatively and after macula-off RD repair using spectral-domain OCT. The researchers correlated preoperative structural changes with postoperative visual acuity and examined those changes over time and correlated them with visual acuity recovery.

The mean macular detachment was 24 days and a statistically significant difference in visual acuity outcomes was found in patients with the macula detached over 20 days. Results for preoperative OCT images correlated to postoperative visual acuity showed that the height of the retinal detachment and distance to the nearest undetached retina were also deemed factors in poor visual outcomes.

However, Dr Irigoyen said that interestingly there seemed to be no correlation with the structure of the detached retina in preoperative OCT images and postoperative visual acuity outcomes, contrary to previous published reports.

In the postoperative OCT images, the postoperative structure of the detached retina was correlated with visual acuity, especially the outer and inner nuclear layers cysts. There was also a strong correlation between postoperative dropout of external limiting membrane and inner/outer segment junction layers, which she said might partly explain the poor visual outcome after RD surgery.

Dr Irigoyen emphasised that future studies with a larger sample size and longer follow-up would be necessary to investigate if the changes detected are reversible and to establish their relationship with visual acuity and photoreceptor regeneration.

“These imaging techniques may provide the objective parameters needed for prospective trials on the efficacy of neuroprotection,” she said.

contact Cristina Irigoyen – cirigoy@hotmail.com

VISUAl OUTCOMESOCT imaging probes relationship between surgery and resultsby Dermot McGrath in London

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retinaUpdate

Postoperative spectral domain-OCT findings after successful anatomical retinal detachment repair. A, Disruption of photoreceptor inner segment outer segment junction (IS/OS), external limiting membrane (ELM) and Verhoeff’s membrane (VM); BCVA 3/60. B, Subretinal

fluid after scleral buckle surgery and IS/OS disruption; BCVA: 6/24. C, Integrity of ELM, IS/OS and VM; BCVA 6/9

Cour

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3rd EuCORNEACONGRESS

6-7 SEPTEMBER

12THEURETINACongress6-9 SEPTEMBER

2nd WORLD CONGRESS OF PAEDIATRIC

OPHTHALMOLOGY AND STRABISMUS

7-9 SEPTEMBER

XXX Congress of the ESCRS

8-12 september

3rd EuCORNEACONGRESS

6-7 SEPTEMBER

12THEURETINACongress6-9 SEPTEMBER

2nd WORLD CONGRESS OF PAEDIATRIC

OPHTHALMOLOGY AND STRABISMUS

7-9 SEPTEMBER

XXX Congress of the ESCRS

8-12 september

The correct diagnosis of vitelliform lesions requires a multimodal approach in order to determine the stage of disease, distinguish

disorders of the retinal pigment epithelium from vascular lesions, and identify those cases where they are symptomatic of malignancy, said Lawrence A Yannuzzi MD, in his Kreissig Lecture, which he delivered at the 11th EURETINA Congress in London, UK.

Vitelliform lesions take their name from vitellus, a Latin word for egg yolk, because of their fried egg-like appearance. They were first described by Frederich Best MD, who gave his name to Best’s disease, a paediatric hereditary disease of the retinal pigment epithelium that is characterised by the presence of the lesions.

Subsequent authors have described the lesions occurring in other diseases of the retinal pigment epithelium, Dr Yannuzzi noted. They include other hereditary disorders such as pattern dystrophy, an adult onset disease, as well as various vitelliform dystrophies whose genetic basis is less clear and which are associated with chronic retinal detachment. There is also a condition called acute exudative vitelliform maculopathy, he said.

Dr Yannuzzi said that pattern dystrophy accounts for about 19 per cent of eyes with vitelliform lesions. In such cases, fundus autofluorescence will show a pattern abnormality, he noted. Acuity remains good in such eyes during the early stages of disease, over time it will decrease in response to compression of the fovea, he said. In addition, the degeneration of the pigment epithelium will result in a fundus hypofluorescence.

Soft drusen will sometimes have a vitelliform appearance. However, in retinal

pigment epithelial dystrophies, OCT will show that the lesions are on top of the retinal epithelium, whereas soft drusen occur beneath the retinal pigment epithelium. Moreover, while both types of lesion can occur in the same eye, unlike soft drusen, retinal pigment epithelium dystrophies will not respond to anti-VEGF injections.

“The diagnosis of this disease is multimodal, you need the fundus autofluorescence and high resolution OCT,” he said.

Another form of drusen which can assume a vitelliform appearance is cuticular drusen. They account for about 20 per cent of eyes with vitelliform lesions. Under fundus autofluorescent imaging, it has yellow-white punctate accumulations which have a “stars in the sky” appearance. In addition, OCT shows their location as below the retinal pigment epithelium (RPE). Fluorescein angiography will provide an inverse negative image of that obtained with fluorescein autofluorescence, he noted.

In addition to Best’s disease and pattern dystrophy, conditions where the lesions are on top of the retinal pigment epithelium include Stargardt’s disease and multifocal pattern dystrophy, and reticular pseudodrusen. Soft drusen and vitelliform pigment epithelium lesions can also occur in the same eye.

Dr Yannuzzi noted that acute exudative vitelliform maculopathy can be idiopathic and benign with a good prognosis in terms of vision. However, in some cases the condition can be neoplastic in origin, and can represent an ocular manifestation of such conditions as malignant melanoma, CNS lymphoma, sarcoidosis, breast cancer or endometrial cancer.

contact Lawrence A Yannuzzi – layannuzzi@gmail.com

EUROTIMES | Volume 16 | Issue 11

ThE dIAGNOSISVitelliform lesions can occur in a broad range of pathologiesby Roibeard O’hEineachain in London

32

retinaUpdate

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The diagnosis of this disease is multimodal, you need the fundus autofluorescence and high resolution OCT

“

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EUROTIMES | Volume 16 | Issue 11

The future is likely to see increasing use of amniotic membrane in battlefield scenarios, where its physical properties as a versatile,

pliable and durable biomaterial make it suitable for treating acute ocular traumatic injuries, according to Major Gerry Clare FRCOphth.

“Amniotic membrane is already widely used in ophthalmology, but its interest in terms of military use derives from the fact that it can be dried and transported and stored at room temperature, which makes it a light, handy and easy biomaterial to use in conflict zones,” Dr Clare said.

Addressing delegates attending a special session of military ophthalmology at the

joint meeting of the European Society of Ophthalmology (SOE) and the American Academy of Ophthalmology, Dr Clare said that the ophthalmic use of amniotic membrane, which is the innermost layer of the placenta and consists of a layer of epithelium overlying a basement membrane and an avascular stromal matrix, is not a recent innovation.

“Foetal membranes were first used as a skin substitute in 1910 and as a conjunctival substitute in 1938 by de Rötth; prior to that, oral mucous membrane had been advocated by Denig as a surgical treatment for ocular burns, highlighting the need for a comfortable, biocompatible ocular surface dressing. In 1941, Brown published

a paper on the treatment of ocular lime burns by covering the entire ocular surface with rabbit peritoneum to promote healing, but this proved unsuccessful. Sorsby and others subsequently used ‘amnioplastin’, chemically processed amniotic membrane, as a temporary patch for treating ocular burns. Although it was recommended for military use in 1949, there were subsequently very few Western publications on amniotic membrane use until it reappeared in the 1990s, when it became available as a frozen product,” he said.

Dr Clare noted that improved methods of processing and preserving amniotic membrane have led to a resurgence of interest in its use as a biomaterial for treating ocular surface burns and acute injuries.

“There are currently over 20 indications for amniotic membrane use in ophthalmology, the commonest ones being persistent epithelial defects, bullous keratopathy and ocular surface reconstruction. It can be obtained frozen or dried and it can be used as a graft or a patch. It can be used directly on the eye or it can be used as a substrate to expand stem cells from the limbus. There is some controversy as to whether it should be used intact with the epithelial layer still on the basement membrane or whether it would be better to remove that first in order to expand the cells,” he said.

In terms of battlefield injuries, Dr Clare said that amniotic membrane might be indicated in cases of ocular injury with associated burns resulting from an improvised explosive device.

“It may be used as a localised multilayered graft for small or impending perforations and also for infectious keratitis. For acute burns it may be used to prevent symblepharon, either as a partial patch over the damaged tissue or as a complete ocular surface dressing, secured with bolsters coming out into the skin or with a ring conformer placed in the fornices,” he said.

However, there is a lack of randomised controlled trials concerning amniotic membrane use in ocular burns. Although the observed clinical effects of amniotic membrane treatment in some studies have

included facilitation of epithelialisation and reduction of inflammation, vascularisation and scarring, high quality evidence for its benefit in treating burns is lacking.

“There has been some interesting work on the use of amniotic membrane in infectious keratitis. While it is doubtful that therapeutic amniotic membrane can retain intrinsic anti-microbial properties, Prof Harminder Dua has surmised that it may act as a kind of reservoir for antibiotic action over time, resulting in healed ulcers after amniotic membrane transplantation,” Dr Clare said.

One of the major advantages of using amniotic membrane is its versatility, said Dr Clare. It can be used as substitute tissue, functioning as a substrate for corneal epithelial cells or as a multilayered scaffold for stromal tissue ingrowth. It may also act as a ‘spacer’ to keep burnt tissues apart and can shield the cornea from ingrowing conjunctiva if required.

While there has been much speculation on the supposed biological action of amniotic membrane, more research is needed before any firm conclusions can be drawn, said Dr Clare.

“We know that it has numerous biochemical components within it, but what we really do not know is whether they work in sufficient quantity to be active on the eye and treat human disease,” he said. “In many cases, biological properties do not need to be inferred to explain the functionality of amniotic tissue as a physical membrane.”

He also noted other limitations associated with amniotic membrane usage.

“There is a lack of RCTs concerning amniotic membrane and many studies have poorly defined criteria of success and failure, so it is not clear what difference the amnion made. There are reports of corneal thinning, fungal keratitis and frank failure after amniotic membrane transplantation. It is also possible that patients may become sensitised if they have repeated exposure to amnion from the same donor. Moreover, it is a heterogeneous tissue, there being variations in biochemical and physical properties between donor membranes and even between samples from the same donor membrane. Methods of preparation and surgical application also vary, and it is often unclear exactly when and how amnion should be applied to the eye for best results,” he concluded.

Despite these limitations, Dr Clare said that the self-evident physical properties of amniotic membrane, particularly its pliability and its durable and versatile nature, are likely to see its increasing use in conflict zones in the future.

Major Gerry Clare – msxgc@nottingham.ac.uk

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AMNIOTIC MEMBRANEVersatile biomaterial suitable for treating acute ocular traumatic injuriesby Dermot McGrath in Geneva

OcularUpdate34

“There are currently over 20 indications for amniotic membrane use in ophthalmology, the commonest ones being persistent epithelial defects, bullous keratopathy and ocular surface reconstruction”

Major Gerry Clare

Don’t miss Out & About, see page 42

OcularUpdate

EUROTIMES | Volume 16 | Issue 11

Delivering the ARVO/Alcon Keynote Lecture during the annual meeting of the Association for Research in

Vision and Ophthalmology, Roderick R McInnes MD, PhD predicted major advances in understanding of the genetics of eye diseases are forthcoming within the next decade.

“Trying to predict the future can be hazardous. However, considering the extensive amount of exciting research under way in genetics and biology, I think it is safe to say that patients and physicians have a great deal to look forward to,” said Dr McInnes, Alva chair in human genetics, director, Lady Davis Research Institute, and Canada research chair in neurogenetics, at the Jewish General Hospital of McGill University, Montreal, Canada.

Interestingly, about 2,500 of the 7,000 known human single gene diseases involve the eye, and although all parts of the eye are represented among the monogenic diseases, it is also remarkable that the number of genes (190 loci, at which the gene has been identified in 155) in which mutations cause retinal degeneration is much greater than the number affecting any other part of the eye, noted Dr McInnes, who is also professor, departments of human genetics and biochemistry, McGill University, Montreal.

So far, the causative gene has been identified for fewer than half of known single gene diseases, and it is believed that another 4,500 to 7,000 more single gene diseases will eventually be identified. While these numbers suggest a monumental challenge, Dr McInnes predicted that the causative gene for virtually all presently known monogenic disease will be identified within the next five to 10 years, thanks to developments in sequencing technologies.

“Recently introduced sequencing technologies are very fast compared with the old tedious methods and relatively inexpensive. Consequently, whole genome sequencing can often find a mutation in a single affected individual without any family history pattern. As the cost per sample for this sequencing continues to fall and reaches $1000 per genome, which geneticists have considered a Holy Grail

for maximising the potential of genomic medicine, the capabilities of this technique will have a huge impact on medicine,” said Dr McInnes.

The power of next-generation sequencing for identifying the causative gene is illustrated by recent research using high-throughput DNA sequencing to resolve the complex genetics of retinitis pigmentosa. As reported in a recent paper [J Med Genet 2011;48:145-51], application of this technology identified the involved gene in four of five unrelated patients with classical RP phenotypes. The same technology also led to identification of a new RP-associated gene, that for dehydrodolichol diphosphate synthase (DHDDS), in three siblings with RP. The disease gene in this family had not been identifiable using earlier techniques.

“This technology does not always find the mutant gene, but it is a great improvement over what has been done until now. In just two years since exome sequencing was introduced, to date it has been used to identify more than 30 disease genes. This is remarkable progress and I think the rate of discovery of disease genes using this technology will be exponential.”

There has also been encouraging recent progress in understanding the genetic basis of common diseases, including eye diseases. The focus in genomic medicine research of common diseases is to identify the variant forms of genes, i.e. alleles that confer disease susceptibility or resistance. This is done by using microarrays to identify single nucleotide polymorphisms (SNPs) throughout the genome. This approach has allowed genome-wide association studies in large populations,

and identified disease-associated variants in more than a hundred common disorders.

“In studies including hundreds to thousands of people and looking at millions of SNPs for disease associations, more than 1,000 genetic variants for polygenic traits, most of them for diseases, had been identified by the end of 2010,” Dr McInnes reported.

“For ocular diseases, at least 15 genome-wide association studies have been done to date and identified loci for AMD, exfoliation glaucoma, myopia and refractive errors, and primary open angle glaucoma, among others,” he said.

For common diseases, recent studies indicate that variations in multiple genes typically contribute to risk, and most of the individual gene variants have modest effects, increasing the relative risk of

disease development perhaps by just 1.1- to 1.4-fold. Therefore, in general, information on gene variants cannot be used to guide patient care. However, there are some exceptions, including AMD, for which the finding of certain combinations of alleles in the alternative complement factor pathway confer a 90 per cent risk of getting the disease, and exfoliation glaucoma, for which certain alleles of the gene for lysyl oxidase-like 1 (LOXL1) increase risk by about 100-fold.

Although the discovery of genetic variant(s) in any individual may not be useful for predicting disease development, identification of these susceptibility genes is important as it can provide valuable insight into the pathophysiology of the disease. To this end, researchers worldwide are working to identify the cohorts of genes that confer risk to various common diseases and will be trying to weave this information together to construct a genetic and biologic network to explain the genetic risk for each disease.

“This will be hard and slow work for biologists in addition to geneticists, but the task will be facilitated by worldwide consortiums that are creating and phenotyping mouse and yeast knockouts, to allow a systems approach to elucidating the biology of newly identified disease-related genes,” Dr McInnes said.

Roderick McInnes – rod.mcinnes@mcgill.ca

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GENOMIC MEdICINEAdvances in sequencing technologies will contribute to rapid gains in knowledgeby Cheryl Guttman Krader in Fort Lauderdale

35

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EUROTIMES | Volume 16 | Issue 11

Despite significant treatment and surgical advances in recent years, cataracts and glaucoma currently remain the biggest

challenges in paediatric ophthalmology and will do into the future, according to the organiser of the 13th International Paediatric Ophthalmology meeting, held in Dublin, Ireland.

Prof Michael O’Keeffe, consultant ophthalmologist, Temple Street Children’s Hospital, Dublin, is the founder of the bi-annual conference, which had a varied and practical programme with attendees from as far away as Australia and America.

The meeting was particularly useful for general ophthalmologists in an Irish context as there is less sub-specialisation in the field compared to larger countries like the US, he explained.

“Attendees get practical sessions on how to deal with children. A lot of people are not comfortable examining children and therefore this helps them. In Ireland it is not as sub-specialised as it is in America where you have purely adult ophthalmologists, paediatric ophthalmologists, etc. You have people here who have to deal with everybody because that’s the way the country functions and I don’t think we could afford anything different,” he said.

Attendees look to get practical sessions and the latest medical and surgical updates out of these meetings, and the Dublin conference was carefully planned, said Prof O’Keeffe. “We run good didactic sessions. We rotate the conditions covered at the conference every time and bring in international speakers.” This year the conference featured speakers from the UK, Switzerland, the US, India, Singapore and Austria as well as Ireland.

Prof O’Keeffe said of particular interest at this year’s conference were the eye movement sessions, presentations on patients with congenital defective vision, and the presentations on glaucoma and cataracts, as well as new techniques in how to deal with retinopathy.

“People are now familiar with Avastin, so if parents come in to them to talk about it, they can learn about it. They got updates on cataract surgery and implants, focusing the eye, and even about prescribing glasses, when to prescribe them and who to prescribe to,” he said.

Congenital cataracts The meeting also featured two specific sessions on cataracts, highlighting their continuing dominance as one of the leading ophthalmological referrals in children.

“Congenital cataracts remain the biggest challenge in paediatric ophthalmology and will remain so in the future. Glaucoma is a nightmare condition to treat, much more difficult to treat than in adults. And the other key challenge I suppose is the number of children to be examined and how to get through the volume of children that now present at clinics and how to be knowledgeable in examining them and treating them,” Prof O’Keeffe elaborated.

Looking ahead in the education calendar, he said he was looking forward to the 2nd World Congress of Paediatric Ophthalmology and Strabismus (WCPOS), which is taking place in Milan next September in conjunction with the ESCRS Congress.

“The first meeting was held in Barcelona [2009] and it was a very good meeting and I think it fits in very well with the ESCRS meeting. It is a very good, practical meeting and I’m looking forward to Milan,” said Prof O’Keeffe.

contactMichael O’Keeffe – HMurphy@materprivate.ie

BIG ChAllENGESCataracts still one of the leading ophthalmological referrals in childrenby Priscilla Lynch in Dublin

37

www.wcpos.org

2nd world congress of paediatric ophthalmology

and strabismus7-9 september 2012

paediatric OphthalmOlOgy

Update

Glaucoma is a nightmare condition to treat, much more difficult to treat than in adults

“Prof Michael O’Keeffe

EUROTIMES | Volume 16 | Issue 11

Ophthalmologists on fixed-term state contracts may have the same rights to promotion as their colleagues in permanent

posts, under a new EU court ruling.The decision by the Court of Justice

would appear to prohibit any state health agency or state-owned hospital or clinic from discriminating against an ophthalmologist just because of her or his current or former employment status in a temporary, interim or fixed-term post.

The case, which involved a challenge by a civil servant working in a regional state agency in Spain, may ultimately affect how Europe’s private hospitals and clinics that receive public money hire and promote their ophthalmologists.

The Spanish case centred on the interpretation of the European Directive on Fixed-Term Work, introduced in 1999. Under the directive, an employer cannot treat fixed-term workers less favourably than permanent workers, unless the

employer can justify the different treatment on objective grounds. That directive was based on a framework agreement created between the European Trade Union Confederation, the Union of Industrial and Employers’ Confederations of Europe, and the European Centre of Employers and Enterprises Providing Public Services.

The Spanish case arose over the treatment of Francisco Javier Rosado Santana, a civil servant working for the regional administrative authority in Andalucía. From 1989 to 2005, Mr Santana worked full-time for the regional authority on fixed-term contracts as a so-called “interim” civil servant. In 2005, he accepted a permanent post as a career civil servant with the same authority.

In 2007, that regional authority published a competition notice for the internal promotion of its career civil servants. One of the conditions for promotion was that candidates had to hold or be able to obtain a bachelor’s degree

or have completed 10 years’ service as a career civil servant. The competition notice stated that no account would be taken of prior periods of service completed as a temporary or interim employee.

Promotion tests Although Mr Rosado Santana could meet neither qualification, the authority allowed him to sit the required promotion tests, which he passed. He was then placed on a list of successful candidates in November of 2008. The next March, however, the, regional authority annulled his promotion on the grounds that he did not have the required bachelor’s degree or 10 years’ seniority as a career civil servant.

Mr Rosado Santana challenged the annulment before the Spanish courts, arguing that his period of service as an interim civil servant should be taken into account for the purposes of calculating the 10 years’ seniority required to be able to take part in the tests for promotion.

When the case reached the Court for Contentious Administrative Proceedings in Seville, that court asked the Court of Justice to rule on whether it was permissible for Spain or any other EU country to disregard a civil servant’s period of service on a fixed-term contract in deciding on promotion.

In a judgment handed down last September, the Court of Justice first found that the Directive on Fixed-Term Work applied to Mr Rosado Santana notwithstanding the fact that he was now a career civil servant. The Court of Justice ruled that his change in status did not deprive him of the protection of the Directive on Fixed-Term Work because the discrimination of which he complained arose because of his former status on a fixed-term contract.

The Court of Justice went on to rule that there must not be any difference in treatment between career civil servants and comparable interim civil servants in an EU country unless the difference in treatment was justified on objective grounds.

Against that background, the Court of Justice ruled that it was for the Spanish court in Seville to establish, first, whether Mr Rosado Santana, when he was working as an interim civil servant, was in a situation comparable with that of the career civil servants admitted to the promotion procedure.

Objective grounds As part of that exercise, the Spanish court or any other EU court must take into consideration the nature of the duties performed by Mr Rosado Santana or any other person in a comparable position for the years worked as an interim civil servant and the quality of the experience acquired in that role.

Accordingly, if the Spanish court were to find that the duties performed by Mr Rosado Santana as an interim civil servant did not correspond to those performed by a career civil servant in the grade required by the competition notice, he could not reasonably claim to be the victim of discrimination.

If, however, it emerged from the Spanish court’s consideration of the duties performed by Mr Rosado Santana as an interim civil servant that his situation was comparable with that of a career civil servant in the grade required by the competition notice, the Spanish court would then, as a second step, have to ascertain whether there was an objective ground justifying the failure to take account, in the context of the selection procedure at issue, of those periods of service.

On that basis, the Court of Justice stated that the concept of “objective grounds” meant that any unequal treatment of a worker on a fixed-term contract could only be justified by precise factors that characterised the specific nature of the employment condition. In deciding what constituted objective grounds, a state authority could not rely merely on the temporary nature of any employment as an “objective ground” for the purposes of the directive.

n For more details visit the Court of Justice website at: www.curia.eu.

PROMOTION PROSPECTSEurope’s state health authorities cannot discriminate against ophthalmologists on fixed-term contractsby Paul McGinn

38

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EUROTIMES | Volume 16 | Issue 11

“Nothing in medicine has made such dramatic changes in the last three decades as the field of cataract surgery.” Thus begins the preface to this book, whose leads authors are Drs Olson and Jin. They provide a vivid pen picture of the standard of care of cataract surgery in the 1970s; a particular older female patient, after a successful two-hour procedure, and after enduring three days of total bed rest with a bed pan in situ, and three months of not being able to lean over below the waist, found her initial ecstatic reaction at her 20/20 vision with an aphakic correction at a three-month postoperative visit replaced by the poignant question on trying to use her new glasses “is there any way you can put my cataract back?”

This is a rapidly evolving field, and one in which any textbook is only up to date at the very moment it is written. The authors have adopted a logical three-part structure to the book; the first section looks in-depth at preoperative investigation and approach. Dr Olson himself contributes the first chapter on patient counselling, which has many wise things to say about patient education and patient selection, and the management of patient expectations.

The book goes on to deal with the preoperative examination and the assessment and grading of the cataract itself. Part of what has revolutionised cataract surgery has been the preoperative assessment. In this it follows a familiar pattern with innovations in medical techniques; while initially the focus is on the wonderful technique itself, after some time it changes to what is done before and after surgery.

The second section deals with intraoperative issues. While the first chapter of this section deals with routine issues intraoperatively, the remainder deal with the approach in more complicated cases and also the intraoperative management of complications such as wound burn, posterior capsular rupture and a shallow anterior chamber.

Finally, the third section deals with the postoperative management – from pharmaceutical interventions to the approach to managing unhappy patients postoperatively. This advice is clear and

straightforward, with a pragmatic focus that characterises the book overall. Finally, the last chapters of the third section deal with the case of cataract surgery after previous refractive surgery, and the future of cataract surgery itself.

The book is reasonably well illustrated with full-colour photographs and diagrams where appropriated. Purchasing the book gives access to a website with videos. It is interesting since I have begun reviewing books for this column how the audiovisual element often bundled with practical books has evolved. There was initially a great sense of novelty about a CD-ROM bundled with a book. Over time it became the norm to have a CD inside the cover. Now with the near-ubiquitous internet, the CD (or CD-ROM) has been dropped in favour of web access.

On that note of technological evolution over the past few years, I would like to wish all readers of this column well. This is my final review for this section, although hopefully not the very last you have read of me in EuroTimes. I wish to thank the editorial team, the administrative staff, the designers, the book authors and publishers and most importantly you the readers for contributing to an enjoyable and interesting tenure in this column.

Cataract surgery

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If you a have a book you would like to have reviewed please send it to: EuroTimes, Temple House, Temple Road, Blackrock, Co Dublin, Ireland

Thursday, February 16• Networking & Welcome

Friday, February 17• Managing Cataract Complications/Complicated Cases:

You Make the Call• Cornea & External Disease:

Practical Topics and Interactive Panel Discussion• Optional Workshop: Astigmatism Management• Optional Workshop: Herpes Simplex/Zoster Ophthalmicus

• Legislative Update

Saturday, February 18• New Technology in Anterior Segment Surgery• Cataract Surgery and Retinal Disease: Evaluation & Treatment• Optional Workshop: Implementing EHR• Optional Workshop: Dilemmas in Co-Management

of Patients with Retinal Disease

• Video Presentations: Complications and Challenging Cases

Sunday, February 19• Challenging Cases for the Comprehensive Clinician• Glaucoma Management Pearls• Optional Workshop: DSEK• Optional Workshop: Glaucoma

• Medicare Update

Monday, February 20• Refractive Surgery Goes Mainstream:

Pearls for the General Ophthalmologist• Faculty Roundtables & Wrap-Up

Experience the ExtraordinaryThis winter, join us for the 5th annual ASCRS Winter Update. Hosted at the FairmontMayakoba in Playa del Carmen, Mexico, the 2012 program continues a tradition of experiential education in an extraordinary location.

Interactive sessions with accessible faculty.Pertinent topics offering practical tips.Spectacular and convenient location.

Program ChairsEdward J. Holland, MDStephen S. Lane, MDRoger F. Steinert, MD

Program CommitteeDavid F. Chang, MDEric D. Donnenfeld, MDRichard A. Lewis, MDKeith A. Warren, MD

FacultyBrock K. Bakewell, MDClara C. Chan, MDVincent P. de Luise, MDLisa M. Gangi, COEW. Barry Lee, MDRichard L. Lindstrom, MDNancey K. McCannTina Pinke, COT, COEE. Ann RoseJonathan B. Rubenstein, MDThomas W. Samuelson, MDPaul Studenbordt, COER. Doyle Stulting Jr., MD, PhDVonda Syler, COEMaureen L. Waddle, MBALiliana Werner, MD, PhD

www.WinterUpdate.org

Register today and save!Book housing online.

Program at a Glance

“ The meeting was great. The casual atmosphere allowed open discussion. My family lovedthe resort and our day trips to Xcaret to snorkel and to Coba to see Mayan ruins.”

Gary J. Foster, MD, Fort Collins, Colorado

Back i

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EUROTIMES November 2011_Layout 1 10/20/11 12:23 PM Page 2

Thursday, February 16• Networking & Welcome

Friday, February 17• Managing Cataract Complications/Complicated Cases:

You Make the Call• Cornea & External Disease:

Practical Topics and Interactive Panel Discussion• Optional Workshop: Astigmatism Management• Optional Workshop: Herpes Simplex/Zoster Ophthalmicus

• Legislative Update

Saturday, February 18• New Technology in Anterior Segment Surgery• Cataract Surgery and Retinal Disease: Evaluation & Treatment• Optional Workshop: Implementing EHR• Optional Workshop: Dilemmas in Co-Management

of Patients with Retinal Disease

• Video Presentations: Complications and Challenging Cases

Sunday, February 19• Challenging Cases for the Comprehensive Clinician• Glaucoma Management Pearls• Optional Workshop: DSEK• Optional Workshop: Glaucoma

• Medicare Update

Monday, February 20• Refractive Surgery Goes Mainstream:

Pearls for the General Ophthalmologist• Faculty Roundtables & Wrap-Up

Experience the ExtraordinaryThis winter, join us for the 5th annual ASCRS Winter Update. Hosted at the FairmontMayakoba in Playa del Carmen, Mexico, the 2012 program continues a tradition of experiential education in an extraordinary location.

Interactive sessions with accessible faculty.Pertinent topics offering practical tips.Spectacular and convenient location.

Program ChairsEdward J. Holland, MDStephen S. Lane, MDRoger F. Steinert, MD

Program CommitteeDavid F. Chang, MDEric D. Donnenfeld, MDRichard A. Lewis, MDKeith A. Warren, MD

FacultyBrock K. Bakewell, MDClara C. Chan, MDVincent P. de Luise, MDLisa M. Gangi, COEW. Barry Lee, MDRichard L. Lindstrom, MDNancey K. McCannTina Pinke, COT, COEE. Ann RoseJonathan B. Rubenstein, MDThomas W. Samuelson, MDPaul Studenbordt, COER. Doyle Stulting Jr., MD, PhDVonda Syler, COEMaureen L. Waddle, MBALiliana Werner, MD, PhD

www.WinterUpdate.org

Register today and save!Book housing online.

Program at a Glance

“ The meeting was great. The casual atmosphere allowed open discussion. My family lovedthe resort and our day trips to Xcaret to snorkel and to Coba to see Mayan ruins.”

Gary J. Foster, MD, Fort Collins, Colorado

Back i

n 201

2

Admini

strato

r Prog

ram Tr

ack

With Ex

pand

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ram

EUROTIMES November 2011_Layout 1 10/20/11 12:23 PM Page 2

EUROTIMES | Volume 16 | Issue 11

From the New World to our world If you only have time to catch one outside event while attending the conference, head for the Czech Museum of Music’s celebration in Czech and English of the 170th anniversary of the birth of Antonín Dvořák. Nearly all of us have heard the Czech composer’s New World Symphony, and you will find the original score here, as well as letters, photographs, recordings and interactive insights into the life of this modest, religious man, who began his career as a humble musician from the countryside, composing popular airs such as the Slavonic Dances and Moravian Duets.

Karmelitská 2/4, 118 00 Prague 1, www.nm.cz, Fri 9.00-18.00, Sat & Sun 10.00-18.00.

Anniversary arias Not to be outdone, Prague’s State Opera has scheduled a performance of Dvořák’s Rusalka for Friday (2 February), but if that’s not to your taste, Saturday offers two chances to see Tchaikovsky’s ever popular Swan Lake, while Sunday rings the changes with Bizet’s Carmen. Built in 1888, the building itself, a glorious confection of gilt and red velvet in the grand tradition, is also something to enjoy.

Rusalka: 19.00; Swan Lake: 14.00 & 19.00; Carmen: 19.00.

Tickets from www.bohemiaticket.cz, or direct from the box office: Wilsonova 4, Praha 1. +420 224 227 266, www.opera.cz

Happy bones With the engaging title of Jolly Skeletons, the Naprstek Museum’s exhibition compares popular Mexican ceremonies with Czech autumn and winter festivals. Are there any similarities between the Mexican Day of the Dead, despite its name, a joyful celebration of life, with European Christmas, Three Kings and masked Carnivals? You’ll find out if you visit.

Betlémské náměstí 1, 110 00 Praha 1, http://www.nm.cz/naprstkovo-muzeum/sbirky.php Fri 10.00-18.00, Sat & Sun 10.00-18.00.

Creation station The main building of the National Museum in Prague may be closed for a much-needed renovation, but the organisation’s work continues in other

locations such as its new building, which in the past few decades has served as stock exchange, parliament and the headquarters of Radio Free Europe. The exhibition Inventions and Inventors uncovers the story of how many everyday objects are of Czech origin and concentrates on the lives and works of 20 inventors from this part of Europe.

Vinohradská 1, 110 00, Praha 1, www.nm.cz, Fri-Sun, 10.00-18.00.

Old tech to high tech Reopened in February 2011, the National Technical Museum, one of the oldest in Europe, was founded in 1908 and gathers its exhibits from near and far. As well as astronomical instruments from the 16th century, used by Tycho Brahe and Johannes Kepler at the court of Rudolf II, Viktor Kaplan’s first turbine and early daguerreotypes, it features the first Czech car, the oldest surviving Bugatti in its refurbished transport display and screenings of the animated films for which Czech cinematographers are famous.

Kostelní 42, Praha 7, www.ntm.cz,Fri-Sun 10.00-18.00.

Nothing to see The Invisible Exhibition sounds like a contradiction but this 90-minute tour led by blind and partially sighted people plunges visitors into total darkness and invites them to explore using only the senses of touch, hearing and smell. The idea is to share some of the experience of being a blind person, and to show that there is beauty in the world that does not rely on vision to reveal itself. Inevitably, perhaps, a visit becomes a trust exercise, too, as visitors have to put themselves in the power of their sightless guides. A parallel exhibition shows the gadgets – talking clocks, Braille

typewriters – that help blind people negotiate the sighted world.

Novoměstská radnice, Karlovo nám. 1/23, 120 00 Praha 2, www.neviditelna.cz

Fri-Sun, 12.00-19.00. Tours in groups of eight every 15 minutes. Tours in different languages and out-of-hours tours can be arranged. Book on: info@neviditelna.cz or telephone + 420 777 787 064.

Vineyard visits Even in winter, Prague’s Botanical Gardens are worth a visit. If the weather is unkind, take shelter in the Fata Morgana greenhouse, considered to be one of the finest in Europe. Planted to resemble three different kinds of natural habitat; tropical rainforest, dry tropics and tropical mountain regions, the displays cover 1,750 square metres. Among the outside plantings, don’t miss St Claire’s vineyard. Its tiny chapel dates back to 1680, but the vineyard itself is thought to have first been planted in the 13th century. It still produces wines, bottles of which are only on sale here.

Nádvorní 134, Praha 7 – Troja 171 00, www.botanicka.cz,

Fri-Sun, 9.00-16.00. Book guided tours on +420 603 582 191 or email: pruvodci@botanicka.cz

Black arts Prague has several black-light theatres, where art and live action, usually mime, play together in a unique way on a black background. At Metro Theatre, under the direction of the artist František Kratochvíl, the company combines basic three-dimensional black theatre, cartoons, dance and pantomime. Each 80-minute performance is followed by a workshop at which the secrets of the illusions you have just seen are revealed.

Národní 25, Prague 1, www.en.divadlometro.cz, Fri-Sun 20.00

Pictures of a revolution After Velvet, an exhibition of the best in contemporary Czech visual art, opened in 2009 to commemorate the 20th anniversary of the Velvet Revolution. Featuring the work of artists who came to prominence well before 1989 as well as those who set up new schools and movements in the dynamic decades that came after, it mixes things up by avoiding a chronological order and showing artists of different generations side by side in the historic Renaissance spaces of the Golden Ring House.

Týnská 6 , Praha 1, www.ghmp.cz,Fri-Sun 10.00-18.00.

CUlTURE APlENTyPrague, which will host the 16th ESCRS Winter Meeting, has some major attractionsby Renata Rubnikowicz

42 Feature

Out & abOut

Prague State Opera – interior

Vineyard – Botanical Gardens

Capsule complications declining?Capsule complications, i.e. communication with the vitreous body, though rare, are one of the feared problems associated with cataract surgery. Swedish researchers report encouraging data from a large review indicating a downward trend in the incidence of this complication. Researchers reviewed data from the Swedish National Cataract Register between 2002 and 2009. This included 602,553 cataract extractions performed at 52 ophthalmic surgery units in Sweden. Capsule complications occurred in 12,574 cataract extractions, corresponding to a frequency of 2.09 per cent. Interestingly, the incidence of this complication consistently decreased each year from 2002 to 2006, after which it stabilised. Risk factor associated with capsule rupture included poor corrected distance visual acuity in the surgical eye, the occurrence of glaucoma, diabetic retinopathy and advanced age. The researchers believe the decline in complications might be explained by the fact that cataract surgery was performed in younger and healthier eyes over the period. However, the complication rate decreased even more in challenging cases, indicating that the surgery has become more technically refined over time. Noting a concern for under reporting, they propose regular validation of randomly chosen clinics and data to improve future data quality.n M Lundström, et al., JCRS, “Decreasing rate

of capsule complications in cataract surgery: Eight-year study of incidence, risk factors, and data validity by the Swedish National Cataract Register”, Volume 37, Issue 10, 1762-1767.

MICS vs. hard cataractsHow does microincision cataract surgery compare with conventional small-incision coaxial phacoemulsification in the treatment of hard cataracts? To evaluate this question, Korean researchers conducted a clinical trial in 180 eyes randomised to have an initial incision of 1.80mm, 2.20mm, or 2.75mm. The eyes in each group were equally randomised to treatment with burst, pulse or continuous mode. At two months postoperatively, they noted no statistically significant differences in ultrasound time, cumulative dissipated energy, corrected distance visual acuity, central corneal thickness, or percentage endothelial cell loss among the three incision groups. The 2.75mm incision induced more astigmatism at two months and less incisional corneal oedema at one week than either of the other groups. Ultrasound time, cumulative dissipated energy, incisional corneal thickness, and central corneal thickness at one week and the percentage endothelial cell loss at two months with continuous mode were statistically significantly higher than with pulse mode and burst mode in

all three incision groups. The researchers conclude that phacoemulsification using microincisions may be as safe and effective as the conventional small incision for hard cataracts.n EC Kim et al., JCRS, “Microincision versus

small-incision coaxial cataract surgery using different power modes for hard nuclear cataract”, Volume 37, Issue 10, 1799-1805.

Keratitis and surface ablationSurface ablation procedures including photorefractive keratectomy (PRK), laser-assisted subepithelial keratectomy (LASEK), and epithelial laser in situ keratomileusis (epi-LASIK), offer the attraction of not less susceptibility to initial or secondary flap complications. However, recovery time is longer and concern remains about the development of infectious keratitis. A large Spanish study evaluated the incidence, culture results, risk factors, treatment strategies and visual outcomes of infectious keratitis after surface ablation. Investigators reviewed the medical records of 9794 patients who had surface ablation between January 2003 and December 2009. Infectious keratitis after surface ablation occurred in 39 eyes of 38 patients, or 0.20 per cent. The onset of infection was early (within seven days after surgery) in 28 cases (71.79 per cent). Cultures were positive in 13 of 27 cases in which samples were taken. The most frequently isolated microorganism was Staphylococcus species. The final corrected distance visual acuity (CDVA) was 20/20 or better in 23 cases (58.97 per cent), 20/40 or better in 36 cases (92.30 per cent), and worse than 20/40 in three cases (7.69 per cent). The researchers emphasise that prompt and aggressive management with an intensive regimen of fortified antibiotic agents is essential. Proper management can preserve useful vision in most cases.n V de Rojas et al., JCRS, “Infectious keratitis in

18,651 laser surface ablation procedures”, Volume 37, Issue 10, 1822-1831.

43

FURTHER STUDYBecome a member of ESCRS to receive a copy of EuroTimes and jcrs journal

Thomas KohnenaSSoCIaTE EDIToR oF jcrs

Live Surgery · Lectures · Video Presentations

Claus Eckardt, Chairman

The program will cover the full spectrum of vitreoretinal

surgery with an emphasis on concepts and techniques.

Audience participation will be encouraged and extensive

discussion will be provided.

Klinik für Augenheilkunde – Klinikum Frankfurt HöchstGotenstraße 6 - 8 · 65929 Frankfurt /GermanyPhone: +49 69.3106-2972 · Fax: +49 69.3106-3695c.eckardt@em.uni-frankfurt.de

Information and registration: www.eckardt-frankfurt.de

FrankfurtRetina MeetingMarch 10th - 11th 2012

2012

Faculty

Donald D'Amico - USACarl Awh - USABill Aylward - Great BritainAdiel Barak - IsraelAudina Berrocal - USATillmann Eckert - GermanyHeinrich Heimann - Great BritainRaymond Iezzi - USAKazuaki Kadonosono - JapanShunji Kusaka - JapanCarlos Mateo - SpainAndreas Mohr - GermanyHassan Mortada - EgyptYusuke Oshima - JapanGrazia Pertile - ItalyStanislao Rizzo - ItalyGabor Scharioth - GermanyCyrus Shroff - IndiaPeter Stalmans - BelgiumPeter Szurman - GermanyRamin Tadayoni - FranceCynthia Toth - USABrian Ward - USAKeith Warren - USADavid Wong - China

anzeigen_FRM2012:eurotimes 12.10.2011 9:55 Uhr Seite 1

Review

Jcrs highlightsJournal of Cataract and Refractive Surgery

EUROTIMES | Volume 16 | Issue 11

EUROTIMES | Volume 16 | Issue 11

Pattern scan laserNIDEK has received FDA Clearance for the MC-500 Vixi, Multicolor Pattern Scan Laser.“This pattern scan laser based on our previous successful technology is our most advanced laser yet, finally offering the choice of any configuration of green, yellow or red colours. This new scanning system demonstrates our continued commitment to the ophthalmic community,” said Motoki Ozawa, president and CEO of NIDEK.nwww.nidek-intl.com

44 Feature

industry newsRecent developments in the vision care industry

New generation of endoillumination

The Xenotron III offers excellent endoillumination with even the smallest fibre optics, said a spokeswoman for Geuder. “By means of maximal light intensity, the Xenotron III optimally illuminates the fundus to provide the surgeon with a better view,” she said. “The unique integrated PHOTOTOXGUARD system continuously monitors the emitted light and warns the surgeon of possible phototoxicity. With this increased safety feature, procedures can be carried out very near the retina.”n www.geuder.com.

Nanosecond laser technology The new SmartTech laser from SCHWIND eye-tech-solutions is striving for a technological revolution in refractive surgery and significant improvements in LASIK procedures.

“Instead of a highly complex femtosecond laser, an innovative microchip laser is used, which operates with blue light in the UV range (355 nm) and produces ultra-short light pulses, each shorter than a billionth of a second,” said a company spokeswoman.”n www.eye-tech-solutions.com/

New retinal imager A new, hi-tech retinal imaging solution that could help prevent diabetes patients from going blind has been released in Europe. The EasyScan system has been developed by i-Optics. “Weighing less than 7kg and with a footprint smaller than a binder, EasyScan is extremely portable – which means imaging can be brought closer to the patient. It consumes little power and it connects to a PC or laptop via a standard USB connection,“ said a spokeswoman.nwww.i-optics.com

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biO-OphthalmOlOgyUpdate

EUROTIMES | Volume 16 | Issue 11

Researchers in Britain, the US and Israel have reported success in halting retinal ganglion cell (RGC) death in animal models.

RGC death, resulting in vision loss and blindness, has been associated with several ocular pathologies including ischemic optic neuropathy and glaucoma. If predictive of what might also be achieved in human eyes, the results provide significant promise for clinical studies using the same therapeutic approach.

The new findings rely on a crucial event in many degenerative retinopathies – the triggering of a molecular cascade that brings about the death of key neuronal cells. This “active” form of cell death, referred to as “apoptosis,” has been well documented in retinitis pigmentosa, age-related macular degeneration and glaucoma and is consequently the focus of numerous therapeutic investigations aimed at inhibiting such final degenerative steps.

Apoptosis is recognised as a major physiological process playing an important role in both developmental biology and human disease. The process is now well understood as a genetically controlled mechanism of cell death in which the cell activates a specific set of instructions which lead to the deconstruction of the cell from within. Such cell death contrasts markedly with the more familiar mechanism known as “necrosis.” Necrosis occurs when a cell is injured mechanically or receives some shock whereby it is unable to continue carrying out the activities of life. Though the end result of both apoptosis and necrosis are the same, that is, the death of the cell, the mechanisms leading to such death are crucially different: necrosis is characterised

by cellular swelling, rupture, leakage and inflammation while apoptosis appears to be a more deliberate and choreographed affair.

Cells dying by apoptosis replace swelling with shrinkage and rupture with an elegant packaging of cellular contents into a convenient size for disposal. There is no leakage of cellular material and no inflammation. The remaining fragments of an apoptosed cell are neatly and quietly disposed of by either neighbouring healthy cells or by the body’s household staff, the macrophages.

Associated diseases Diseases associated with too much apoptosis include neurodegenerative disorders such as retinitis pigmentosa, Parkinson’s disease, and Alzheimer’s while diseases associated with too little apoptosis include a broad range of cancers in which the natural checks to inhibit uncontrolled cell proliferation have been lost.

The actual mechanics of apoptosis are mediated by a specific set of proteins – the “caspases” – which are responsible for the deconstruction of the cell from within. Once the caspases are activated the process of orderly shut-down begins and so researchers have naturally sought to find ways to block caspase activation and activity in order to halt cell death.

The death of RGCs is a hallmark of certain ophthalmic diseases including ischemic neuropathy, non-arteritic ischemic optic neuropathy, glaucoma, and others. In developing tools to interfere with the apoptotic process, researchers – at the University of Birmingham in the UK and at Quark Pharmaceuticals in the US and Israel – focused their attention on one specific

caspase – “caspase-2” – known to act as both an initiator and an executioner in the process of apoptosis. To block the effects of caspase-2, the researchers designed specific nucleic acid inhibitors known as short-interfering ribonucleic acids – “siRNA.” These naturally occurring molecules are found throughout the plant and animal kingdoms. So momentous was their discovery in the 1990s that two American researchers received a Nobel Prize for Medicine and Physiology in 2006.

The discovery of “RNAi” – ribonucleic acid interference – is now understood to be a method for silencing genes by destroying the intermediate molecule – mRNA – that carries information encoded in DNA out into the cell cytoplasm where it is generally translated into protein. Harnessing such technology is of fundamental importance as it provides a potent means to specifically block protein production by interfering in the process of translation – the mechanism by which cells make proteins from RNA templates. By destroying the template, you destroy the ability of the cell to make the protein described in the RNA.

Synthetic sIRNAs In this research, synthetic siRNAs were generated by the University of Birmingham and Quark research teams and were specifically designed to target the mRNA of caspase-2. Blocking such translation prevented caspase-2 protein from mediating cell death in the retinal ganglion cell (RGC) population. The results of the research, published in the journal Cell Death & Differentiation (doi:10.1038/cddis.2011.54), showed that intravitreal delivery of anti-caspase-2 synthetic siRNA, “siCASP2”, significantly enhanced RGC survival in a dose dependent manner for over 30 days without inducing an interferon response. The chemically modified siRNA persisted in the retina for over one month and was detected in other retinal cells besides RGCs. A single dose of siCASP2 delivered on day zero and day 10 appeared to completely protect against RGC death for the first week and to maintain cell survival out to 30 days; however, higher doses, while showing no toxicity, did not increase RGC survival.

“Stabilised siCASP2 exhibits a long residence time in the rat eye after intravitreal administration, is taken up readily by RGC, activates RNAi, is neuroprotective after RGC axotomy and, therefore, may be a useful therapeutic in ophthalmic diseases that involve RGC death,” the researchers concluded.

The studies provide encouraging support for human clinical studies using siCASP2 to inhibit caspase-2 activity in the retinal ganglion cell population of patients suffering from optic nerve atrophy, and non-arteritic ischemic optic neuropathy.

RETINAl ThERAPy AdVANCEAnti-apoptotic results using siRNA may preview potential benefits for optic nerve atrophy and glaucoma patientsby Gearoid Tuohy

46

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The actual mechanics of apoptosis are mediated by a specific set of proteins – the “caspases” – which are responsible for the deconstruction of the cell from within

Rome2nd EURETINA Winter Meeting ‘Innovation in Management of Retinal Disease’

Rome Cavalieri Waldorf Astoria Hotel

Saturday 28 January 2012

Included topics:• Imaging

• Eye and Brain

• Regeneration and Degenerationof the Retina

• Retina and Stem Cells

• Gene Transfer

• Retina Basic Research

www.euretina.org

Reference48

calendar Of eventsDates for your Diary

February2012

3-5prague, czech republic

16th ESCRS Winter Meetingwww.escrs.org

January

November

April June

2012

2011

2012 2012

1-4

9-10

22-2717-22

28

12-13

23-26

21 14-17

vienna,austria

zurich, switzerland

berlin,germany

copenhagen,denmark

rome,italy

athens, greece

dublin, ireland

milan,italy

belgrade, serbia

nurnberg,germany

International Symposium on Ocular Pharmacology and Therapeuticswww.isopt.net

7th International Congress ofCorneal Cross-Linking www.cxl-congress.org

ISER 2012XX Biennial Meeting of the International Society for Eye Researchwww2.kenes.com/iser/pages/home.aspx

10th EGS Congresswww.eugs.org

2nd EURETINA Winter Meetingwww.euretina.org

Practice Development Workshop and Masterclasswww.escrs.org/dublin2011

91st SOI National Congresswww.soiweb.com

International Symposium on Glaucoma – New Insights and Updateswww.glaucoma–belgrade2012.org

25th International Congress of German Ophthalmic Surgeonswww.doc-nuernberg.de

December

JulyJune

2011

20122012

6-7 6-97-9

13-15

8-12

milan, italy milan, italy

3rd EuCornea Congress www.eucornea.org

12th EURETINA Congresswww.euretina.org

2nd World Congress of Paediatric Ophthalmology and Strabismuswww.wcpos.org

7th Pan-Hellenic Vitreo-Retinal Meetingwww.gvrs.gr

XXX Congress of the ESCRSwww.escrs.org

SeptemberSeptember20122012

March March

February

20122012

2012

16-171-4

16-20

22-2510-11

23-25

2nd EuroLam Macula and Retina Congresswww.euro-lam.org

26th International Congress of the HSIOIRSwww.hsioirs.org

World Ophthalmology Congress www.woc2012.org/

The 3rd World Congress on Controversies in Ophthalmology (COPHy)www.comtecmed.com/COPHy/2012/

Frankfurt Retina Meetingwww.eckardt-frankfurt.de

XVI National Congress of Italian Society of Corneal Transplantwww.sitrac.it

miami, usa

athens, greece

abu dhabi,uae

istanbul, turkey

mainz, germany

rome, italy

Advertising Directory: Alcon Laboratories: Page: OBC; Allergan Ophthalmology: Page: 44; ASCRS / Eyeworld Pages: 36, 40-41; Carl Zeiss Meditec AG Page: 29; D.O.R.C International BV Pages: 24, 43; European Glaucoma Society Page: 32; Mater Hospital Page: 12; Medicel AG Page: 21; Medicontur Page: 7; NIDEK Page: 27; Oculus Optikgeraete GmbH Page: 28; Oertli Instruments AG Page: IBC; Schwind Eye-Tech Solutions Page: IFC; S.I.TRA.C. Page: 22; Technolas Perfect Vision Page: 11; VSY Biotechnology Page: 3; Ziemer Ophthalmic Systems AG Page: 39

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Cataract Surgery Will Change in a Femtosecond.

With Alcon’s LenSx® Laser, the Possibilities Have Just Begun.Delivering the accuracy of a femtosecond laser to Refractive Cataract Surgery, the LenSx® Laser is designed to predictably perform many of the most challenging aspects of traditional cataract surgery. Creating highly reproducible capsulotomy, lens fragmentation and all corneal incisions with image-guided surgeon control, Alcon’s LenSx® Laser is Putting the Future in Motion.

To learn more about LenSx® Laser technology for Laser Refractive Cataract Surgery, visit lensxlasers.com.

©2011 Alcon, Inc. 3/11 LSX11500S0V-D

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76557 LSX11500S0V-D ET.indd 1 9/12/11 9:58 AM