A Guide to Comprehensive Dry Eye Diagnostics with the OCULUS ...

A Guide to Comprehensive Dry Eye Diagnostics with the OCULUS Keratograph 5M

1st Edition, September 2015

Foreword by Professor Kohji NishidaWritten by Shizuka Koh and Tresia De Jager

Edited by Lars Michael

i

Table of Contents

Foreword by Professor Kohji Nishida............................................................................................................................ iv

About the Authors........................................................................................................................................................ v

Dr. Shizuka Koh, Tresia de Jager.................................................................................................................................... v

Introduction.................................................................................................................................................................. 1

Dry Eye Disease............................................................................................................................................................. 2

Importance of Dry Eye Testing...................................................................................................................................... 3

Overview: Dry Eye Disease Classification....................................................................................................................... 3

Dry Eye Disease Test Procedures................................................................................................................................... 5

The OCULUS Keratograph 5M – a Revolution in Dry Eye Screening.............................................................................. 6

Dry Eye and Tear Film Analysis Tests of the Keratograph 5M....................................................................................... 9

Tear Meniscus Height (TMH)........................................................................................................................................ 9

Non-Invasive Keratograph Break-Up Time (NIKBUT)..................................................................................................... 14

Meibography with the Keratograph 5M Meiboscan..................................................................................................... 22

Tear Film Lipid Layer Examination.................................................................................................................................. 29

Tear Film Dynamic Examination.................................................................................................................................... 32

Scleral Redness Grading (R-Scan)................................................................................................................................... 33

Staining......................................................................................................................................................................... 36

Camera.......................................................................................................................................................................... 37

JENVIS Report Summary............................................................................................................................................... 45

Additional Displays....................................................................................................................................................... 48

Corneal Topography...................................................................................................................................................... 49

Automatic Keratoconus Detection................................................................................................................................. 55

Contact Lens Fitting Software........................................................................................................................................ 50

OxiMap®....................................................................................................................................................................... 51

Frequently Asked Questions......................................................................................................................................... 52

Additional Readings...................................................................................................................................................... 53

ii

Table of Figures

FIGURE 1: MAJOR ETIOLOGICAL CAUSES OF DRY EYE................................................................................................... 4

FIGURE 2: MAGNIFICATION CHANGER OF KERATOGRAPH 5M FOR DIFFERENT TEST PROCEDURES............................ 7

FIGURE 3: ILLUMINATION SYSTEM OF KERATOGRAPH 5M........................................................................................... 7

FIGURE 4: KERATOGRAPH 5M TMH USING THE INFRARED ACQUISITION FUNCTION.................................................. 9

FIGURE 5: TMH USING THE WHITE LIGHT ACQUISITION FUNCTION............................................................................. 9

FIGURE 6: KERATOGRAPH 5M TMH NORMAL EYE........................................................................................................ 10

FIGURE 7: TMH OF AQUEOUS-TEAR DEFICIENT DRY EYE.............................................................................................. 11

FIGURE 8: FLUORESCEIN STAINING IMAGES OF AQUEOUS-TEAR DEFICIENT DRY EYE................................................. 11

FIGURE 9: TMH OF EVAPORATIVE DRY EYE WITH MGD................................................................................................ 12

FIGURE 10: FLUORESCEIN IMAGE OF EVAPORATIVE DRY EYE WITH MGD.................................................................... 12

FIGURE 11: TMH OF EYE WITH EPIPHORA.................................................................................................................... 13

FIGURE 12: TMH OF EYE WITH CONJUNCTIVAL CHALASIS............................................................................................ 13

FIGURE 13: FLUORESCEIN IMAGE OF EYE WITH CONJUNCTIVAL CHALASIS.................................................................. 14

FIGURE 14: KERATOGRAPH 5M NIKBUT ACQUISITION WINDOW.................................................................................. 15

FIGURE 15: KERATOGRAPH 5M NIKBUT RESULT MAP................................................................................................... 15

FIGURE 16: DETAILED NIKBUT AND AUTOMATIC CLASSIFICATION, HERE ‘LEVEL 0’...................................................... 15



FIGURE 19: NORMAL NIKBUT RESULT............................................................................................................................ 18

FIGURE 20: SHORT NIKBUT RESULT................................................................................................................................ 18

FIGURE 21: FLUORESCEIN IMAGE OF ABOVE PATIENT................................................................................................... 19

FIGURE 22: NIKBUT RESULT OF AQUEOUS-DEFICIENT DRY EYE BEFORE TREATMENT................................................... 20

FIGURE 23: FLUORESCEIN IMAGE OF AQUEOUS-DEFICIENT DRY EYE BEFORE TREATMENT......................................... 20

FIGURE 24: NIKBUT RESULT OF AQUEOUS-DEFICIENT DRY EYE AFTER TREATMENT..................................................... 21

FIGURE 25: FLUORESCEIN IMAGE OF AQUEOUS-DEFICIENT DRY EYE AFTER TREATMENT............................................ 21

FIGURE 26: KERATOGRAPH 5M MEIBOSCAN ACQUISITION WINDOW.......................................................................... 22

FIGURE 27: KERATOGRAPH 5M MEIBOSCAN SOFTWARE FOR ENHANCED VISUALIZATION OF GLANDS...................... 22

FIGURE 28: MEIBOGRAPHY OF THE UPPER EYE LID WITH DIFFERENT GRADES............................................................ 23

FIGURE 29: MEIBOGRAPHY OF THE LOWER EYE LID WITH DIFFERENT GRADES........................................................... 24

FIGURE 30: NORMAL MEIBOSCAN RESULT..................................................................................................................... 25

FIGURE 31: MEIBOSCAN WITH SHORTENED GLANDS................................................................................................... 25

FIGURE 32: MEIBOSCAN WITH DROPOUT OF GLANDS................................................................................................. 26

FIGURE 33: FLUORESCEIN IMAGE OF SAME PATIENT..................................................................................................... 26

FIGURE 34: MEIBOSCAN AFTER RADIOTHERAPY............................................................................................................ 27

FIGURE 35: LOSS OF EYELASHES AND ABNORMAL LID MARGIN WAS OBSERVED........................................................ 27

FIGURE 36: MEIBOSCAN WITH MASCARA DOTS........................................................................................................... 28

FIGURE 37: BASELINE EXAMINATION............................................................................................................................ 28

FIGURE 38: AFTER 3 MONTHS TREATMENT................................................................................................................... 28



FIGURE 41: TEAR FILM LIPID LAYER EXAMINATION WITH THE KERATOGRAPH 5M...................................................... 29

FIGURE 42: SLIT LAMP: ± 0.5MM OBSERVABLE FIELD................................................................................................... 30

FIGURE 43: KERATOGRAPH 5M: ±9MM OBSERVABLE FIELD.......................................................................................... 30

FIGURE 44: NORMAL LIPID LAYER................................................................................................................................. 30

iii

Table of Figures

FIGURE 1: MAJOR ETIOLOGICAL CAUSES OF DRY EYE................................................................................................... 4

FIGURE 2: MAGNIFICATION CHANGER OF KERATOGRAPH 5M FOR DIFFERENT TEST PROCEDURES............................ 7

FIGURE 3: ILLUMINATION SYSTEM OF KERATOGRAPH 5M........................................................................................... 7

FIGURE 4: KERATOGRAPH 5M TMH USING THE INFRARED ACQUISITION FUNCTION.................................................. 9

FIGURE 5: TMH USING THE WHITE LIGHT ACQUISITION FUNCTION............................................................................. 9

FIGURE 6: KERATOGRAPH 5M TMH NORMAL EYE........................................................................................................ 10

FIGURE 7: TMH OF AQUEOUS-TEAR DEFICIENT DRY EYE.............................................................................................. 11

FIGURE 8: FLUORESCEIN STAINING IMAGES OF AQUEOUS-TEAR DEFICIENT DRY EYE................................................. 11

FIGURE 9: TMH OF EVAPORATIVE DRY EYE WITH MGD................................................................................................ 12

FIGURE 10: FLUORESCEIN IMAGE OF EVAPORATIVE DRY EYE WITH MGD.................................................................... 12

FIGURE 11: TMH OF EYE WITH EPIPHORA.................................................................................................................... 13

FIGURE 12: TMH OF EYE WITH CONJUNCTIVAL CHALASIS............................................................................................ 13

FIGURE 13: FLUORESCEIN IMAGE OF EYE WITH CONJUNCTIVAL CHALASIS.................................................................. 14

FIGURE 14: KERATOGRAPH 5M NIKBUT ACQUISITION WINDOW.................................................................................. 15

FIGURE 15: KERATOGRAPH 5M NIKBUT RESULT MAP................................................................................................... 15




FIGURE 19: NORMAL NIKBUT RESULT............................................................................................................................ 18

FIGURE 20: SHORT NIKBUT RESULT................................................................................................................................ 18

FIGURE 21: FLUORESCEIN IMAGE OF ABOVE PATIENT................................................................................................... 19

FIGURE 22: NIKBUT RESULT OF AQUEOUS-DEFICIENT DRY EYE BEFORE TREATMENT................................................... 20

FIGURE 23: FLUORESCEIN IMAGE OF AQUEOUS-DEFICIENT DRY EYE BEFORE TREATMENT......................................... 20

FIGURE 24: NIKBUT RESULT OF AQUEOUS-DEFICIENT DRY EYE AFTER TREATMENT..................................................... 21

FIGURE 25: FLUORESCEIN IMAGE OF AQUEOUS-DEFICIENT DRY EYE AFTER TREATMENT............................................ 21

FIGURE 26: KERATOGRAPH 5M MEIBOSCAN ACQUISITION WINDOW.......................................................................... 22

FIGURE 27: KERATOGRAPH 5M MEIBOSCAN SOFTWARE FOR ENHANCED VISUALIZATION OF GLANDS...................... 22

FIGURE 28: MEIBOGRAPHY OF THE UPPER EYE LID WITH DIFFERENT GRADES............................................................ 23

FIGURE 29: MEIBOGRAPHY OF THE LOWER EYE LID WITH DIFFERENT GRADES........................................................... 24

FIGURE 30: NORMAL MEIBOSCAN RESULT..................................................................................................................... 25

FIGURE 31: MEIBOSCAN WITH SHORTENED GLANDS................................................................................................... 25

FIGURE 32: MEIBOSCAN WITH DROPOUT OF GLANDS................................................................................................. 26

FIGURE 33: FLUORESCEIN IMAGE OF SAME PATIENT..................................................................................................... 26

FIGURE 34: MEIBOSCAN AFTER RADIOTHERAPY............................................................................................................ 27

FIGURE 35: LOSS OF EYELASHES AND ABNORMAL LID MARGIN WAS OBSERVED........................................................ 27

FIGURE 36: MEIBOSCAN WITH MASCARA DOTS........................................................................................................... 28

FIGURE 37: BASELINE EXAMINATION............................................................................................................................ 28




FIGURE 41: TEAR FILM LIPID LAYER EXAMINATION WITH THE KERATOGRAPH 5M...................................................... 29

FIGURE 42: SLIT LAMP: ± 0.5MM OBSERVABLE FIELD................................................................................................... 30

FIGURE 43: KERATOGRAPH 5M: ±9MM OBSERVABLE FIELD.......................................................................................... 30

FIGURE 44: NORMAL LIPID LAYER................................................................................................................................. 30

FIGURE 45: THICK LIPID LAYER....................................................................................................................................... 31

FIGURE 46: THIN LIPID LAYER......................................................................................................................................... 31

FIGURE 47: KERATOGRAPH 5M TEAR FILM DYNAMIC EXAMINATION........................................................................... 32

FIGURE 48: NORMAL VISCOSITY OF TEAR FILM ........................................................................................................... 33

FIGURE 49: LOW VISCOSITY OF TEAR FILM................................................................................................................... 33

FIGURE 50: R-SCAN SOFTWARE ACQUISITION WINDOW............................................................................................... 33

FIGURE 51: R-SCAN RESULT INCLUDING AUTOMATIC REDNESS GRADING ACCORDING TO JENVIS............................. 34

FIGURE 52: R-SCAN OF SEVERE RED EYE, CLASSIFIED AS 3.9 (ON A SCALE OF 0 TO 4)................................................. 35

FIGURE 53: R-SCAN BASELINE EXAMINATION............................................................................................................... 36

FIGURE 54: R-SCAN AFTER 1 MONTH OF TREATMENT.................................................................................................. 36

FIGURE 55: R-SCAN AFTER 3 MONTHS OF TREATMENT................................................................................................. 36

FIGURE 56: R-SCAN AFTER 9 MONTHS OF TREATMENT................................................................................................. 36

FIGURE 57: INTEGRATED JENVIS STAINING GRADING SCALE......................................................................................... 36

FIGURE 58: KERATOGRAPH 5M EXAMPLE OF FLUORESCEIN IMAGE............................................................................. 37

FIGURE 59: OD: FIRST BREAK-UP OF 3.06 SECONDS...................................................................................................... 38

FIGURE 60: OS: FIRST BREAK-UP 4.21 SECONDS........................................................................................................... 38

FIGURE 61: OD: 0.16MM.............................................................................................................................................. 39

FIGURE 62: OS: 0.16MM............................................................................................................................................... 39

FIGURE 63: OD: BULBAR REDNESS INDEX 1.2............................................................................................................... 39FIGURE 64: OS: BULBAR REDNESS INDEX 1.2................................................................................................................ 40

FIGURE 65: OD: NO MEIBOMIAN GLAND LOSS NOTED.................................................................................................. 40

FIGURE 66: OS: NO MEIBOMIAN GLAND LOSS NOTED.................................................................................................. 40

FIGURE 67: OD: FIRST BREAK-UP 6.31 SECONDS........................................................................................................... 42

FIGURE 68: OS: FIRST BREAK-UP 6.12 SECONDS............................................................................................................ 42

FIGURE 69: OD: 0.27MM............................................................................................................................................... 42

FIGURE 70: OS: 0.30MM............................................................................................................................................... 43

FIGURE 71: OD: BULBAR REDNESS INDEX 0.9............................................................................................................... 43

FIGURE 72: OS: BULBAR REDNESS INDEX 0.9................................................................................................................ 44

FIGURE 73: OD: NO MEIBOMIAN GLAND LOSS NOTED IN UPPER AND LOWER LID...................................................... 44

FIGURE 74: OS: NO MEIBOMIAN GLAND LOSS NOTED IN UPPER AND LOWER LID...................................................... 45

FIGURE 75: JENVIS REPORT OF THE KERATOGRAPH 5M............................................................................................... 46

FIGURE 76: JENVIS REPORT RESULTS COLOR CODED INDIVIDUALLY AND COMBINED ON RADAR CHART.................... 47

FIGURE 77: JENVIS REPORT ADDING ADDITIONAL TESTS.............................................................................................. 48

FIGURE 78: JENVIS REPORT PERSONALIZED E-MAIL CREATED FOR EACH INDIVIDUAL PATIENT................................... 48

FIGURE 79: JENVIS REPORT AS RECEIVED WHEN E-MAILED......................................................................................... 48

FIGURE 80: KERATOGRAPH 5M OVERVIEW DISPLAY: KERATOMETRY, CURVATURE, ELEVATION AND POWER DATA.... 51

FIGURE 81: KERATOGRAPH 5M INDICES DISPLAY: CORNEAL ABNORMALITIES DETECTED AUTOMATICALLY................ 52

FIGURE 82: KERATOGRAPH 5M CONTACT LENS FITTING SOFTWARE............................................................................ 52

FIGURE 83: A SIMULATED FLUORESCEIN IMAGE CALCULATED AFTER A SPECIFIC LENS IS CHOSEN............................. 51

FIGURE 84: OXIMAP® LOW DK/T PERIPHERAL............................................................................................................... 51

FIGURE 85: OXIMAP® HIGH DK/T CENTRAL AND PERIPHERAL..................................................................................... 51

FIGURE 86: CORRECT LOCATION FOR TMH MEASUREMENT?...................................................................................... 53

iv

Foreword by Professor Kohji NishidaOsaka University Graduate School of Medicine, Japan

In their first edition of ‚The Guide to Comprehensive Dry Eye Diagnostics with the OCULUS Keratograph 5M‘, Dr Koh and Mrs De Jager proof that dry eye does not necessarily have to be a dry topic in literature. The two authors combine their clinical and technical expertise, as well as their ophthalmology and optometry viewpoints to present their practical experience about dry eye diagnosis.

They shine light on the complexity of diagnosing this very common, multifactorial disease, and introduce how improved optics and new unique features added onto an established technology, namely a Placido-based topographer, can enhance every optometrist‘s and anterior segment surgeon‘s dry eye clinic of today.

Ocular health, successful contact lens fitting as well as excellent cataract and refractive surgery results first of all require a well-managed ocular surface, not to forget pain-free eyes of our patients. The key to diagnose various factors of dry eye disease and to find the cause of it may lay in using a more comprehensive approach with mainly non-invasive diagnostic methods that are easy to integrate into our clinics, systematically report our findings, and quickly and efficiently communicate those and individual advisable treatment options to our patients.

This practical guide explains detailed and step-by-step how different types of dry eye disease are diagnosed with a new unique piece of equipment, the OCULUS Keratograph 5M. Interested readers and users of this diagnostic unit can ease their challenging task and cut short their time to enhance dry eye diagnosis and treatment. Rich in real-life examples, readers can profit from direct advice by one of the leading dry eye experts from Japan using one of the most advanced diagnostic tools of today.

v

About the AuthorsDr. Shizuka Koh

Shizuka Koh, MD, is an Assistant Professor of the Department of Ophthalmology, at Osaka University Graduate School of Medicine, Osaka, Japan. She received her MD from Osaka University Medical School in 1999.

After her residency and fellowship at Osaka University Hospital, she completed her research fellowship at Flaum Eye Institute, University of Rochester, New York. She specializes in corneal diseases, ocular surface diseases and ocular optics. Her interests in research include tear film dynamics and dry eye as well as the evaluation of optical quality in ocular surface diseases, amongst others. As a member of the Tear Film & Ocular Surface Society and the Japan Dry Eye Society, she stays abreast with the latest developments in the field. In addition, Dr Koh is an active member of the Lid and Meibomian Gland Working Group (LIME) in Japan.

Awards for her academic contributions include The Japan Cornea Society‘s Promising Investigator Award (2014), Johnson & Johnson Contact Lens Research Award (2014), The Japan Contact Lens Society‘s Young Investigator Award (2013), Dry Eye Research Award (2007) and Alcon Japan Clinical Award (2006).

Aside from her interest in ophthalmology, she plays the hammered dulcimer which she mastered during her stay in Rochester, NY.

Tresia de Jager

After almost a decade in private practice, working as optometrist for a premier eye care group in South Africa, Tresia relocated to Hong Kong. In 2011 she joined the OCULUS Asia team, a direct subsidiary of OCULUS Optikgeraete GmbH, Wetzlar, Germany as clinical consultant.

Tresia has presented at various ophthalmology and optometry meetings throughout the Asia-Pacific region including Hong Kong, Vietnam, the Philippines and Indonesia. She continues to facilitate application trainings and workshops for various OCULUS diagnostic devices covering visual field testing, anterior segment imaging with Scheimpflug, Orthokeratology, and has developed specific interest in dry eye diagnostics with the Keratograph 5M.

1

Introduction

As a medical practitioner what is the first thought that comes to mind when hearing the term dry eye disease? Burning, blurry vision, irritation, tearing, redness, photophobia, pain… to name but a few.

Compared to other conditions being treated on a daily basis in clinics, this on the surface, appear not to be of most importance. However this may be the single condition presenting in our clinics far more often than realized, undiagnosed in a lot of cases and in severe cases, if left untreated, can have devastating effects.

It is exactly for this reason that we have written this guide, not only raising awareness about the condition, but also assisting clinicians making comprehensive dry eye screening part of the daily routine. In the end, alleviating your patient’s discomfort from dry eyes may prove to make the world of difference for them.

Shizuka Koh Tresia De Jager

August 2015

2

Dry Eye Disease

Dry eye disease (DED) is a chronic, symptomatic ocular surface disease. Estimates currently show that approximately 100 million people are affected by this condition worldwide1, however in many cases DED is underdiagnosed and left untreated.

During the 2007 International Dry Eye WorkShop the condition was defined as a multifactorial disease2, characterized by impairment of the integrity of tear film and cornea that affects visual function in a limited manner (e.g., in advanced or severe cases). The cornea is the first transparent tissue of the eye and the tear film ensures a smooth refracting surface. As a result, the instability of a disrupted tear film over the irregular surface of a dry eye is thought to be associated with optical disturbances.

The reality is, every clinic globally where visual services are provided, are subjected to DED patients on a daily basis. By definition various factors contribute to the prevalence of DED and therefore no single diagnostic test can successfully be used on its own to diagnose DED, but a combination of various test increases correct diagnosis and treatment. DED affects the quality of vision, but also damages the eye; therefore it is essential that eye care professionals acquire the necessary knowledge and equipment for proper diagnosis and treatment.

1 Hillen M, The Burden of Dry Eye Disease, The Ophthalmologist March 17, 2015, Issue #03152 The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye

WorkShop (2007). Ocul Surf. 2007;5:75-92.

3

Importance of Dry Eye Testing

DED is one of the most common ocular disorders; its growing prevalence demands our attention. Correct diagnosis and treatment can improve simple daily tasks (working on a PC, being in a room with a fan, etc.) for our patients, but can also assist in refractive surgery screening procedures, premium intraocular lens selection, contact lens fitting, to name only but a few.

1. Symptom improvement: Experiencing dry eye symptoms can be rather debilitating for patients. Improving on simple things like foreign body sensation, dryness, ocular fatigue, constant tearing, irritated, itching eyes among others can make quite a big difference for DED patients.

2. Surgery screening: It is important to examine the ocular surface conditions pre-operatively in each individual eye to optimize surgical outcomes. Pre-existing dry eye can affect cataract refractive surgical outcomes. It has been reported that DED is a very common complication of refractive procedures such as Lasik. Dry eye screening is an important step in the refractive procedure decision making process.

3. Contact lens intolerance: DED is a contra-indication for successful contact lens fitting.

4. General screening: Various systemic, endocrine and other medical conditions have dry eye as one of the manifestations.

Overview: Dry Eye Disease Classification

The tear film is a very thin layer over the ocular surface. A deficiency in either quantity or quality of the tear film can lead to DED. This results in a general classification for DED, namely, aqueous-deficient and evaporative dry eye, both of which can be influenced by the effect of environmental factors. See figure 1 below for dry eye classification according to the 2007 Report of the International Dry Eye WorkShop.

4

Figure 1: Major etiological causes of dry eye3

Both aqueous-deficient and evaporative dry eye can lead to increased evaporation and decreased tear film stability. Distinguishing between these two groups and determining if they exist individually or as a combination is crucial for DED diagnosis and treatment.

Evaporative dry eye is more common, and accounts for 35-45% of all dry eye cases, but both forms usually occur simultaneously in the most severe cases4. Recently, short tear film break-up time type dry eye has been regarded as a sub-type of dry eye.

It is reported to be associated with decreased tear film stability observed as a shorter tear film break-up time and dry eye symptoms without ocular surface damage and tear deficiency5,6.

3 From 2007 Report of the International Dry Eye WorkShop (Ocul Surf. 2007)4 Lemp MA et al. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea.

2012;31:472-478.5 Toda I, et al. Dry eye with only decreased tear breakup time is sometimes associated with allergic conjunctivitis. Ophthalmology.

1995;102:302–309.6 Koh S, et al. Effects of suppression of blinking on quality of vision in borderline cases of evaporative dry eye. Cornea. 2008;27:275–278.

5

Dry Eye Disease Test Procedures

The following is an overview of non-invasive versus invasive test procedures.

Test type / Result InvasiveMinimally Invasive/Non-

Invasive

QuantitativeSchirmer test Phenol red thread test

Tear meniscus height

Qualitative

Fluorescein BUT (Break-up time)

Fluorescein staining

Tear osmolarity

White light interferometry

NIBUT (Non-Invasive Break-Up Time)

Flow behaviour

Further tests

Rose Bengal / lissamine green staining

Impression cytology

Blink rate assessment

Redness grading

Noncontact meibography

Table 1: Overview of important dry eye analysis tools

Traditionally, common objective diagnostic clinical tests assessing the tear film and diagnosing DED are known as the Schirmer test and fluorescein tear film break-up time (BUT). It has been shown that low reproducibility, sensitivity and specificity7 are disadvantages of the Schirmer test. In addition, the test is invasive in nature. The BUT is most frequently assessed with fluorescein installation, although this technique can destabilize the tear film8.

7 Lucca JA, et al. A comparison of diagnostic tests for keratoconjunctivitis sicca: lactoplate, Schirmer, and tear osmolarity. CLAO J. 1990;16:109–112.

8 Mengher LS, et al. A non-invasive instrument for clinical assessment of the pre-corneal tear film stability. Curr Eye Res. 1985;4:1-7.

6

Non- or minimally invasive dry eye tests have the major advantage that data is captured from the surface of the eye without significantly inducing reflex tearing.

These types of non-invasive techniques have the potential to represent the “true” state of the ocular surface9. It is important to note that the induction of reflex tearing can subsequently affect results of tests following the invasive procedure. Therefore the inclusion of non-invasive tests should be done prior to any invasive test in the DED testing line up. Patient comfort, objective results and the ability to measure the tear film in the steady-state further contributes to non-invasive testing advantages.

Recent advances in new technologies have enabled us to non-invasively evaluate the quantity and quality of the tear film. One such instrument is a relatively new, commercially available Placido topographer, the Keratograph 5M, manufactured by OCULUS Optikgeraete GmbH, Wetzlar, Germany.

The OCULUS Keratograph 5M – a Revolution in Dry Eye Screening

A high-resolution color camera and integrated magnification changer open up entirely new perspectives in professional tear film analysis. The tear film can be assessed with both white and infrared light. Tear film volume (Tear Meniscus Height - TMH), tear film stability (Non-Invasive Keratograph Break-Up Time – NIKBUT) and Meibomian gland observation (Meiboscan) can easily be assessed with the Keratograph 5M. Presence of symptoms and different signs assist with the classification of DED, as seen in the table below, the Keratograph 5M forms part of this evaluation process.

9 Methodologies to diagnose and monitor dry eye disease: report of the Diagnostic Methodology Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007;5:108-152.

7

Figure 2: Magnification changer of Keratograph 5M for different test procedures

Courtesy: OCULUS Optikgeraete GmbH Germany

Figure 3: Illumination system of Keratograph 5M

Courtesy: OCULUS Optikgeraete GmbH Germany

8

Subjective symptoms

Tear volumeTear film stability

Ocular surface staining

Meibomian gland

dysfunction (MGD)

Normal - Normal Normal - -

Aqueous- deficient dry

eye+

(Assessed by Keratograph 5M

TMH)

Low


NIKBUT)

Decreased

+


Meiboscan)

+/ -

Evaporative dry eye &

MGD+


TMH)

Normal / Low


NIKBUT)

Decreased

+


Meiboscan)

+

Table 2: Use of Keratograph 5M as screening device for DED

9

Figure 4: Keratograph 5M TMH using the infrared acquisition function

Figure 5: TMH using the white light acquisition function

• Objective To evaluate the quantity of the tear film

• Method o TMH image recorded o TMH measured with a built-in ruler. Generally, TMH is measured in line with the pupil

center. o Normal TMH > 0.20mm o Irregular TMH can be evaluated along the lid margin o Magnification changer assists with image evaluation

Dry Eye and Tear Film Analysis Tests of the Keratograph 5MTear Meniscus Height (TMH)

A camera image is taken with either infrared or white illumination allowing measurement of the TMH.

10

• Tips and advice o To avoid artificial high readings due to reflex tearing from other tests, the first test

performed during tear film assessment should be the TMH measurement o It may be better to measure TMH a few seconds after the blink to avoid post-blink TMH

change o If conjunctival chalasis or lid parallel conjunctival folds (LIPCOF) exist, accurate TMH

measurement can be difficult• Step by step 1. Enable ‘TMH’ button 2. Select IR or white light 3. Magnification, exposure and gain can be changed if necessary 4. Adjust the camera image to display tear meniscus centrally 5. Focus on the lower tear meniscus 6. Record image by pressing ‘Image” button or alternatively using the foot switch

Case examples of TMH measurement 1. Normal TMH

Figure 6: Keratograph 5M TMH normal eye

27 year old, male patientTMH measured along the lid margin inferior to the pupil centerMeasured TMH is 0.25mm

11

2. Aqueous-tear deficient dry eye

Figure 7: TMH of aqueous-tear deficient dry eye

20 year old, female patientAqueous-deficient dry eye with Sjögren’s syndromeMeasured TMH is 0.08mm which is a remarkable decreased TMH

Fluorescein staining images of same patient

Figure 8: Fluorescein staining images of aqueous-tear deficient dry eye

Schirmer test score of 3mm and BUT of 2 seconds

Notes:

A blue-free barrier filter is yellow and works as a barrier filter for fluorescein. This filter is a useful tool in detecting damaged conjunctival epithelium in dry eyes 10,11.

Conjunctival epithelial damage in aqueous-deficient dry eye with Sjögren’s syndrome is greater than those in aqueous-deficient dry eye with non-Sjögren’s syndrome.

10 Koh S, et al. Diagnosing dry eye using a blue-free barrier filter. Am J Ophthalmol. 2003;136;513-519.11 Bron AJ. Diagnosis of dry eye. Surv Ophthalmol. 2001;45(suppl):S221-S226.

12

3. Evaporative dry eye & MGD

Figure 9: TMH of evaporative dry eye with MGD

66 year old, female patientEvaporative dry eye with MGDVascular engorgement at the lid margin is observedMeasured TMH is 0.20mmFluorescein staining image of same patient

Figure 10: Fluorescein image of evaporative dry eye with MGD

Anterior displacement of the mucocutaneous junction is observed (blue arrows).Schirmer test score of 15mm and BUT of 5 seconds

Note:Important to know, unlike aqueous-deficient dry eye, TMH is not always decreased with evaporative dry eye

13

4. Eye with epiphora

Figure 11: TMH of eye with epiphora

45 year old, female patientPatient complaining of excessive tearingMeasured TMH is 0.68mm (Note: Remarkable increase)

5. Eye with conjunctival chalasis

Figure 12: TMH of eye with conjunctival chalasis

47 year old, female patientDry eye with conjunctival chalasisDue to the conjunctival chalasis, accurate TMH measurement is difficult.

14

Fluorescein staining image of same patient

Figure 13: Fluorescein image of eye with conjunctival chalasis

The patient was diagnosed with Sjögren’s syndrome. In addition to dry eye, conjunctival chalasis may contribute to the ocular surface damage (Blue line indicates the edge of the conjunctival folds).

Schirmer test score of 1mm and BUT of 2 seconds.

Non-Invasive Keratograph Break-Up Time (NIKBUT)

Placido rings are reflected on the corneal surface. The software analyzes different segments and a distortion in the reflected mires is recorded as a break in the tear film. The results are displayed in a color-coded map, where red/orange segments correspond with a faster break-up time. A break-up characteristics map shows the total area (%) of the cornea affected during the measuring time. The time when the first break in the tear film occurred is displayed, as well as the average time of all the break-ups that occurred during the measurement. The software automatically grades the level according to the JENVIS grading scale, see below figures.

15

Figure 14: Keratograph 5M NIKBUT acquisition window

Important: Ask the patient to blink twice when prompted by the software!

Figure 15: Keratograph 5M NIKBUT result map

Figure 16: Detailed NIKBUT and automatic classification, here ‘Level 0’

Color-coded map: colors corresponding with time the break-ups occurred

Break-up characteristics map

First, average break-up time & classification

16



• Objective To evaluate the quality (stability) of the tear film

17

• Method o Instruct the patient to blink naturally. Avoid unnatural/forced/double blinks. o When device is aligned, notice will be given to instruct patient to blink twice. After the

second blink, measurement will automatically begin. o Instruct and motivate the patient to keep his/her eyes open without blinking. o Measurement is automatically terminated if the patient blinks, moves strongly, or the

tear film significantly breaks up. o A break-up characteristics map display total area of the cornea being affected by breaks

in the tear film. o First and average break-up time is displayed in the results display.

• Reported values: 9.7 ± 6.7 seconds for normal eyes and 4.6 ± 1.3 seconds for dry eyes12 (Study from Japan). 4.3 ± 0.3 seconds for normal eyes and 2.0 ± 0.2 seconds for dry eyes13 (Study from China).

• Tips and advice o Perform measurement of NIKBUT after TMH measurement o Dry eye patients: First break-up area recordet with NIKBUT shows a tendency of

occuring in the inferior cornea. First tear film break-up area during fluorescein BUT is also generally observed in these areas

• Step by step 1. Enable ‘NIKBUT’ button 2. Select infrared or white light 3. Adjust camera if necessary 4. When aligned, prompt “Blink twice” appears on the screen 5. Instruct patient to blink twice 6. Measurement automatically activated after second blink

12 Koh S, et al. Upper and lower difference in tear film stability and meibomian glands in dry eye. Eye & Contact Lens. In press13 Hong J, et al. Assessment of tear film stability in dry eye with a newly developed keratograph. Cornea. 2013;32:716-721.

18

Case examples of NIKBUT

1. Normal

Figure 19: Normal NIKBUT result

27 year old male patientThe patient kept his eyes open for 25 seconds without blinking during the measurement. The color-coded map is displayed in a uniformly green color, indicating a good tear film stability.The first break-up was detected and recorded at 23.2 seconds.

2. Aqueous-tear deficient dry eye with Sjögren‘s syndrome

Figure 20: Short NIKBUT result

59 year old, female patient Patient blinked 10.66 seconds after the measurement started, ending the measurement.

19

Dark orange or red colors are displayed in the inferior, central part of the color-coded map. This is an indication that break-up occurred faster in this area.The first break-up was detected and recorded at 3.25 seconds.

Fluorescein staining image of same patient

Figure 21: Fluorescein image of above patient

This patient suffered from a dry mouth due to Sjögren’s syndrome and this resulted in her being referred to the eye clinic. She did not receive any dry eye treatment prior to this examination.Schirmer test score of 5mm and BUT of 2 seconds.

20

3. Aqueous-deficient dry eye pre- and post-dry eye treatment45 year old, female patient

Pre-treatment

Figure 22: NIKBUT result of aqueous-deficient dry eye before treatment

Patient blinked 19.75 seconds after measurement started, ending the measurement.The inferior part of the color-coded map is displayed mainly with orange and yellow colors, indicating that most of the break-up occurred in this area.The first break-up was detected and recorded at 4.33 seconds.

Fluorescein staining image of same patient before the treatment

Figure 23: Fluorescein image of aqueous-deficient dry eye before treatment

21

Post-treatment of the same patient

Figure 24: NIKBUT result of aqueous-deficient dry eye after treatment

3 weeks after the dry eye treatment with 3% diquafosol ophthalmic solution (Diquas, ophthalmic solution 3%, Santen Pharmaceutical Co. Ltd, Osaka, Japan), tear film stability improved. Her first break-up was detected at 7.78 seconds.

Fluorescein staining image of same patient after treatment

Figure 25: Fluorescein image of aqueous-deficient dry eye after treatment

Improved corneal fluorescein staining in inferior cornea was observed after the treatment of diquafosol ophthalmic solution for 3 weeks.

Note:

Diquafosol is a drug used for dry eye treatment by stimulating the secretion of tear fluid and mucin on the ocular surface. The 3% diquafosol ophthalmic solution is currently available in Japan and South Korea. (at the time of writing in August, 2015)

22

Figure 26: Keratograph 5M Meiboscan acquisition window

Figure 27: Keratograph 5M Meiboscan software for enhanced visualization of glands

• Objective To observe and evaluate the morphological changes in the meibomian glands.

• Method o Eversion of the lids is necessary o Large working distance allows the observation and eversion of the eyelids o Upper and lower lid images can be recorded separately o Recorded images can be enhanced by activating Meibo analysis

Meibography with the Keratograph 5M Meiboscan

Inclusion of infrared diodes in the hardware of the Keratograph 5M makes it possible to trans-illuminate the upper and the lower eyelid.

23

Figure 28: Meibography of the upper eye lid with different grades

• Tips and advice o Meibomian glands are arranged separately throughout the tarsal plates of the upper

and lower eyelids14. Meibomian glands in the upper eyelid are larger in number and longer than those in the lower eyelid15.

o Use of Meiboscore grading would be helpful to grade or complete loss of meibomian glands16.

Meiboscore grading with the Keratograph 5M

14 Knap E, et al. The international workshop on meibomian gland dysfunction: report of the subcommittee on anatomy, physiology, and pathophysiology of the meibomian gland. Invest Ophthalmol Vis Sci. 2011;52:1938-1978

15 Greiner JV, et al. Volume of the human ad rabbit meibomian gland system. Adv Exp Med Biol. 1998;438:339-343.16 Arita R, et al. Noncontact infrared meibography to document age-related changes of the meibomian glands in a normal population.

Ophthalmology. 2008;115:911-915

24

Figure 29: Meibography of the lower eye lid with different grades

• Meiboscore grading o Grade 0: No loss of meibomian glands o Grade 1: Loss of less than 1/3 of the total meibomian gland area o Grade 2: Loss of 1/3 to 2/3 of the total area o Grade 3: Loss of more than 2/3 of the area

• Step by step 1. Enable the ‘Meibo Upper/lower button’ 2. Evert the upper eyelid first 3. Adjust camera if necessary 4. Position the camera that the upper eyelid is positioned in the red-framed recording box 5. Focus the camera on the meibomian glands to get a clear image 6. Record image by pressing ’Image’ or alternatively using the foot switch 7. Repeat for the lower lid

25

Figure 30: Normal Meiboscan result

27 year old, male patientThe Meibomian glands appeared as hyperluminescent grapelike clusters in the upper and lower eyelid.

2. Age-related meibomian gland dropout

Figure 31: Meiboscan with shortened glands

74 year old, male patientRemarkable dry eye and abnormal lid margins were not noted, however, dropout and shortening of meibomian glands are observed.

• Case examples of Meiboscan1. Normal eye

26

3. Meibomian gland dysfunction (MGD)

Figure 32: Meiboscan with dropout of glands

45 year old, female patientOnly a few meibomian glands are observed in both the upper and lower lid.

Fluorescein staining image of the same patient

Figure 33: Fluorescein image of same patient

On referral to the eye clinic, she had not been receiving any prior dry eye treatment.Schirmer test score of 14mm and BUT of 3 secondsShe was diagnosed as evaporative dry eye with MGD.

27

4. After radiotherapy

Figure 34: Meiboscan after radiotherapy

44 year old, female patientThe patient received radiotherapy for the treatment of lacrimal gland tumor 6 months ago. Remarkable meibomian gland loss is observed both in upper and lower lids.

Slit lamp image

Figure 35: Loss of eyelashes and abnormal lid margin was observed

28

5. Black dots - mascara inside

Figure 36: Meiboscan with mascara dots

35 year old, female patientBlack dots shown in the image is mascara.The Meiboscan images are used as educational tools to inform patients about possible ocular surface damage due to excessive mascara/eye pencil on eyelid.

6. Case report: MGD patient receiving medicinal treatment 43 year old, female patient

Figure 37: Baseline examination Figure 38: After 3 months treatment

No glands visible Mild reactivation of gland tissue in lower eyelid

29

Figure 39: After 6 months treatment Figure 40: After 9 months treatment

Upper eyelid ducts visible Improvement of upper and lower eyelids gland tissue

Data courtesy above figures: University Eye Clinic Düsseldorf, Germany

Tear Film Lipid Layer Examination

The principle of white light interferometry is used while a video or image is recorded by the Keratograph 5M.

Figure 41: Tear Film Lipid Layer Examination with the Keratograph 5M

• Objective Assessing the quality of the lipid layer in the tear film

• Method o Video recording makes lipid layer assessment easier o Instruct the patient to blink during recording o Magnification changes can be done during recording

30

• Tips and advice o Lots of colorful fringes indicates a thicker lipid layer o To be able to optimally assess the distribution of the lipid on the surface of the tear

film, record the lipid layer for the duration of two to three eyelid blinks

• Step by step 1. Enable the ‘Lipid layer’ button 2. Move the device in small increments to the patient’s eye 3. Focus the Placido rings properly 4. Move the device slowly back and focus on the lipid layer

Press ‘IMAGE’ to capture an image, ‘Rec’ to record a video. Stop recording press ‘Stop’. Alternatively use the foot switch.

Case examples of lipid layer examination1. Comparing lipid layer examination between Keratograph 5M and a slit lamp

Figure 42: Slit lamp: ± 0.5mm observable field Figure 43: Keratograph 5M: ±9mm observable field

2. Normal lipid layer

Figure 44: Normal lipid layer

31

30 year old, male patientNormal lipid layer are indicated by the bronze reflections being seen on the image.

3. Thick lipid layer

Figure 45: Thick lipid layer

32 year old, female patient

Increase in color fringes is an indicator of a thicker lipid layer.

4. Thin lipid layer

Figure 46: Thin lipid layer

45 year old, female patient

White, colorless reflections can be observed. This patient has a thin lipid layer.

Note:

Observation of tear film lipid layer is better with video function

32

Figure 47: Keratograph 5M Tear Film Dynamic Examination

• Objective Analysis of the tear film viscosity

• Method o The amount, movement and speed of particles found in the tear film is assessed with a

video recording o A fast speed of particles in the tear film after each blink is an indication of a normal

tear film o If the movement is sluggish or a lot of particles in the illuminated area are observed,

this is indicative of an irregular/highly viscous tear film

• Step by step 1. Enable ‘Tear film-Dynamic’ button 2. Adjust the camera if needed 3. Focus the two light spots observed in the inferior cornea. The tear film must be clearly

focused 4. To capture an image, press the ‘Image’ button. To record a video, press ‘Rec’. 5. Press ‘Stop’ to stop recording. Foot switch can be used to perform these functions

Tear Film Dynamic Examination

Video recording (up to 32 frames per second) performed by the Keratograph 5M is used to observe the distribution of particles in the tear film.

33

Case examples of tear film dynamic examination

Figure 48: Normal viscosity of tear film Figure 49: Low viscosity of tear film

Normal Viscous tear film

Notes:

Best results for the tear film dynamic examination can be observed with a video recording. Not only the amount of particles is observed, but also the speed of moving particles assists to determine the viscosity of the tear film. Slow/sluggish movement and increase in the amount of particles seen after the blink is an indication of a more viscous tear film.

Scleral Redness Grading (R-Scan)

The software detects the thin conjunctival vessels and evaluates sclera to blood ratio determining the degree of redness.

Figure 50: R-Scan software acquisition window

34

Figure 51: R-Scan result including automatic redness grading according to JENVIS

• Objective Automatic classification of the bulbar redness

• Method o An image of the anterior surface of the eye is taken o Software analyzes the thin conjunctival vessels, evaluating sclera-to-blood vessel ratio.

The results is an automatic and objective finding relating to the degree of redness according the JENVIS grading scale

o A further classification between bulbar and limbal redness is done. Degree of temporal versus nasal redness for these areas is separately displayed

• Tips and advice o Separate peri-limbal area analysis makes it easier to grade the ciliary flush. This is

important for follow up in cases with uveitis17.

• Step by step 1. Enable the ‘Bulbar Redness’ button 2. Align the camera so that the grey disc covers the iris 3. Press the ‘Image’ button, alternatively use the foot switch

17 Marguerite McDonald MD, Kelly Alexis Fumuso, Shakira Senior, Wendy Fernandez, The tech’s role in dry eye diagnostic testing Implementing dry eye diagnostic testing improves efficiency and care Optometry Times November 2014

35

Case examples of R-Scan1. Bulbar Redness

Figure 52: R-Scan of severe red eye, classified as 3.9 (on a scale of 0 to 4)

31 year old, male patient

Patient presented with a severe red eye. The software analyzed the thin conjunctival vessels and bulbar redness 3.9 was documented.This enhances patient education regarding their eye condition and aids in follow up examinations to show effectiveness of treatment.

Please note that by clicking on the limbal redness icon, the software simultaneously can grade the degree of limbal redness for the same patient.

36

2. Case report: MGD patient receiving treatment – inflammatory reaction improvement

43 year old, female patient (same patient as above discussed in meibography case report)

Figure 53: R-Scan baseline examination Figure 54: R-Scan after 1 month of treatment

Total redness of 2.4 Total redness of 2.6

Figure 55: R-Scan after 3 months of treatment Figure 56: R-Scan after 9 months of treatment

Total redness decreased to 1.3 Total redness improved to 0.8

Courtesy above figures: University Eye Clinic Düsseldorf, Germany

Staining

The Keratograph 5M software includes the integrated JENVIS grading scale, which facilitates the classification and grading of corneal staining. Every image taken can be compared with a sample image on the screen.

Figure 57: Integrated JENVIS staining grading scale

37

Figure 58: Keratograph 5M example of fluorescein image

Case report

History and symptoms

44 year old patient presented with the following symptoms:• Foreign body sensation• Burning sensation• Dryness• Fluctuating vision

Day 1Visual acuity: OD – 0,5 OS – 0,5

Camera

The high-resolution camera makes for superior quality images. Real time adjustments of the digital zoom, different lightning options and exposure time can easily be done. As a result high quality images of the ocular surface, cornea, conjunctiva, lashes, lids and even fluorescein break up time is obtained18. The color imaging function can be used to create real-life fluorescein images or videos, permitting assessment and documentation of the fit and movement of the contact lens.

18 Christopher Kent, Dry-Eye Diagnosis: 21st-Century Tools As technology advances, our ability to uncover and monitor the disease continues to improve. Review of Ophthalmology 2013

38

NCT: OD – 10.2mmHg OS – 9mmHg

Traditional diagnostic test resultsOSDI (Ocular surface disease index): 52.27Conjunctival hyperemia grading done with slit lamp: OU – 1 (mild conjunctival hyperemia)BUT (Fluorescein break-up time): OD – 3 seconds OS – 4 secondsSchirmer test score of: OD – 1mm OS – 3mmCorneal fluorescein staining: OU: 1 (less than 5 stains noted)

Keratograph 5M dry eye tests resultsNIKBUT

Figure 59: OD: First break-up of 3.06 seconds

Figure 60: OS: First break-up 4.21 seconds

39

TMH

Figure 61: OD: 0.16mm

Figure 62: OS: 0.16mm

R-Scan

Figure 63: OD: Bulbar redness index 1.2

40

Figure 64: OS: Bulbar redness index 1.2

Meibo-Scan

Figure 65: OD: No meibomian gland loss noted

Figure 66: OS: No meibomian gland loss noted

41

Treatment:

Evaluation of the patient’s test results, combined with the symptoms she was diagnosed with aqueous-deficient dry eye.

SYSTANE® ultra lubricant eye drops (Alcon Laboratories Inc, Fort Worth, TX, USA) prescribed as an artificial tear supplement.

0.02% flurometholone prescribed as an anti-inflammatory agent, taken 4x daily

Day 20 (after treatment started)

Visual acuity: OD – 1.0 OS – 0.8

NCT: OD – 9.2mmHg OS – 9mmHg

OSDI: 38.81

Conjunctival hyperemia graded with the slit lamp: 0 (mild hyperemia)

BUT: OD – 5 seconds OS – 5 seconds

Schirmer test score of: OD – 2mm OS – 5mm

Corneal fluorescein staining: 0

Keratograph 5M Results

42

NIKBUT

Figure 67: OD: First break-up 6.31 seconds

Figure 68: OS: First break-up 6.12 seconds

TMH

Figure 69: OD: 0.27mm

43

Figure 70: OS: 0.30mm

R-Scan

Figure 71: OD: Bulbar redness index 0.9

Figure 72: OS: Bulbar redness index 0.9

44

Meibo-Scan

Figure 73: OD: No meibomian gland loss noted in upper and lower lid

Figure 74: OS: No meibomian gland loss noted in upper and lower lid

Conclusion of this case:

After 20 days of dry eye treatment the patient signs and symptoms improved. The OCULUS Keratograph 5M assisted not only with the diagnostic process, but made patient education easier.

Case data with courtesy of Zhongshan Ophthalmic Centre, Sun Yat-Sen University, Guangzhou, Peoples Republic of China, Professor Jin Yuan, research fellow Yuqing Deng

45

Figure 75: JENVIS Report of the Keratograph 5M

• Objective Find the cause of dry eye quickly and reliably, but most importantly educate patients

about their eye conditions, aiming to increase treatment compliance

• Method o Drawing up a comprehensive dry eye report entails: - Dry eye questionnaire OSDI (Ocular surface disease index) or McM (McMonnies) - Measuring LIPCOF (lid parallel conjunctival folds) with the slit lamp - Four measurements with the Keratograph (TMH, NIKBUT, R-Scan, and Meibo-Scan) o Various other screening methods and results (ranging from eyelid blink rate to staining)

can be included in the report o Results of individual examination displayed as blue dot on a color coded bar o A combination of six (questionnaire, LIPCOF, four Keratograph 5M measurements) will

be displayed on a radar chart in a hexagon shape o A detailed printout containing a summary of all performed measurements/

examinations can be generated and given to the patient/customer. This report can also be e-mailed directly to patient/customer.

JENVIS Report Summary

Comprehensive Dry Eye Report

46

• Tips and advice o Dry eye screening is not limited to only a few tests and there are various different tests

available that clinicians can perform o The JENVIS Dry Eye Report allows the clinicians to add tests at their own discretion to

complete their screening process o Tests are performed from non-invasive to invasive o Additional notes can be added to report by clinicians

• Instructions for JENVIS Dry Eye Report use 1. Click on ‘Examination’ button and choose ‘New JENVIS Dry Eye Report’ 2. To start the first measurement (TMH) please click on the button “New” 3. Measurement window automatically opens, perform TMH measurement 4. Repeat procedure for subsequent tests 5. Results will be shown on color coded bar and combination of six test’s results displayed

on radar chart

Figure 76: JENVIS report results color coded individually and combined on radar chart

47

• Add additional tests o Click on the ‘Add’ button o Dropdown list with different tests displayed o Individually activate whichever test/s as needed o Results of these tests will be displayed on color coded bars, but not on the radar chart

Figure 77: JENVIS report adding additional tests

• Generate printout report o Different treatment options can be activated in the ‘text block’ field o Additional notes in the ‚text block’ field can be written for each individual patient o Click on ‘Print’ in top bar of display o Click on ‚email‘ to send report via email

48

Figure 78: JENVIS report personalized e-mail created for each individual patient

Figure 79: JENVIS report as received when e-mailed

Additional DisplaysApart from the unique dry eye analysis functions, the Keratograph 5M also measures topography according to gold standard rules. These topography functions include various topography maps, automatic keratoconus detection, Zernike, Fourier analysis and topography guided contact lens fitting software, latter also useful for Orthokeratology.

49

Corneal Topography

The Keratograph 5M supplies precise, reliable data for determining both the pre- and postoperative status, measuring up to 22,000 data points. In combination with automatic measurement release, the integrated keratometer guarantees perfect reproducibility. Various graphical representations (axial, tangential, elevation and refractive power) are available.

Figure 80: Keratograph 5M Overview Display: keratometry, curvature, elevation and power data

Automatic Keratoconus Detection

Corneal alterations such as keratoconus can be diagnosed at an early stage. The Indices display shows the topographic keratoconus stage. Based on a combination of several indices this output field characterizes the stage of development of the keratoconus. Besides classification into any of stages 1-4, it may also show the attribute “possible” in cases of suspected incipient keratoconus. The present classification has been adapted as far as possible to Amsler and Muckenhirn stages. However, one should always bear in mind that this assessment by the Keratograph software is entirely based on topography and is not to be regarded as a basis for a clinical diagnosis. Besides staging, the software is capable of producing comments in this field such as “severely deformed cornea”, “status following corneal surgery” or “keratoglobus” whenever it encounters topographic features indicative of such conditions.

50

Figure 81: Keratograph 5M Indices Display: corneal abnormalities detected automatically

Contact Lens Fitting Software

The topography data generated by Keratograph creates the basis for professional contact lens fitting software. Data are generated by contact-free measurement, evaluated automatically and represented in diagrams which offer a wealth of information. An extensive, continuously updated contact lens database is available for finding the most suitable lens or simulating fluorescein images. Additional contact lens data can be easily imported by the user.

Figure 82: Keratograph 5M Contact lens fitting software

In the Contact lens fitting software, topographical data is used to calculate the mathematically best fitting contact lenses. The most appropriate lens will be displayed at the top of the list. A simulated fluorescein image will be calculated as shown below when a specific lens is chosen.

51

Figure 83: A simulated fluorescein image calculated after a specific lens is chosen

OxiMap®

An intact tear film and good oxygen supply to the cornea are indispensable for contact lens wearing comfort. The OxiMap®, which is easy to understand, represents oxygen transmissibility as a function of refractive power. Oxygen transmissibility also depends on the material and thickness of the contact lens. Manufacturers still quote oxygen transmissibility globally with reference to the centre of a minus 3.00 D contact lens. The OxiMap® provides a graphic representation of Dk/t values over the entire surface of the lens as a function of refractive power, which is much more realistic.

Figure 84: OxiMap® low Dk/t peripheral Figure 85: OxiMap® high Dk/t central and peripheral

Visualization of oxygen transmissibility of minus 3.00 D lenses made from different lens material. The material of the lens shown on the right has higher oxygen transmissibility than the lens on the left.

52

Frequently Asked Questions

Q1: Can we perform NIKBUT measurement even in severe dry eye?A1: NIKBUT measurement for dry eye with severe corneal epithelial damage is difficult.

Even when the NIKBUT measurement is performed in such cases, the device mostly reports the results as “too short”.

Q2: Is NIKBUT value the same as fluorescein tear film break-up time (TFBUT)? A2: The differences between fluorescein TFBUT and NIKBUT values should be noted,

although positive correlation between TMH and Schirmer test values has been reported.19,20

Q3: Why are sometimes white areas displayed in the color-coded map of the NIKBUT display?

A3: White areas are displayed if the patient blinks before 15 seconds after the measurement started. This does not affect the measurement in any way.

Q4: Does abnormal corneal shape i.e. keratoconus affect NIKBUT measurement?A4: No, the software detects a basic image. In the case of keratoconus for example the

strained Placido rings induced by the condition is noted initially by software and distortions from the original image is recorded and indicated as a break in the tear film. However, in cases with advanced keratoconus or severe irregular corneal astigmatism, it is hard to perform the measurement.

19 Ibrahim O, et al. Application of Visante optical coherence tomography tear meniscus height measurement in diagnosis of dry eye disease. Ophthalmology. 2010;117:1923-1929.

20 Wang J, et al. Correlations among upper and lower tear menisci, non-invasive tear break-up time and Schirmer’s test. Am J Ophthalmol. 2008;145:795-800.

53

Q5: Looking at the image below, which is the correct TMH?

Figure 86: Correct location for TMH measurement?

A5: The 0.22mm measurement is the true representation of the TMH. Measurement should be done from the white to white border of the meniscus

Q6: In some cases, RF scan evaluating bulbar redness cannot detect the conjunctival area correctly.

A6: In eyes with small lid aperture or eyes with ptosis, (commonly seen in the older Asian population), the device cannot detect the conjunctival area correctly.

Q7: What and who is JENVIS?A7: Founded in 2005, JENVIS is an independent research institute located in Jena, Germany.

The institute is directly connected to the Department of Optometry at the University of Applied Sciences in Jena. Their main focus is performing impartial and unprejudiced research studies. For more info, please visit: http://www.jenvis-research.com/jenvis/

Q8: What are the particles being observed during the tear film dynamic examination?A8: The particles are a combination eroding corneal epithelial cells, tarsal conjunctival cells

and small air-particles

Q9: Can data from the Keratograph be exported for research?A9: Yes, data from the NIKBUT, R-scan and all keratometric data can be exported to csv

files.

54

Additional Readings

2015

1. Assessment of Bulbar Redness with a Newly Developed Keratograph. Wu S, Hong J, Tian L, Cui X, Sun X, Xu Optom Vis Sci. 2015;92:892-899. doi:10.1097/OPX.0000000000000643.

2. Infrared imaging of meibomian glands and evaluation of the lipid layer in Sjögren‘s syndrome patients and nondry eye controls. Menzies KL, Srinivasan S, Prokopich CL, Jones L Invest Ophthalmol Vis Sci. 2015;56:836-841. doi:10.1167/iovs.14-13864.

3. Effect of non-invasive tear stability assessment on tear meniscus height. Koh S, Ikeda C, Watanabe S, Oie Y, Soma T, Watanabe H, Maeda N, Nishida K Acta Ophthalmol. 2015;93:e135-e139. doi: 10.1111/aos.12516. Epub 2014 Oct 12.

4. Agreement between Automated and Traditional Measures of Tear Film Breakup. Cox SM, Nichols KK, Nichols JJ. Optom Vis Sci. 2015 Jul 3. [Epub ahead of print]

5. Noninvasive Imaging of Tear Film Dynamics in Eyes With Ocular Surface Disease. Abdelfattah NS, Dastiridou A, Sadda SR, Lee OL. Cornea. 2015 Jul 29. [Epub ahead of print]

2014

6. Imaging meibomian glands on a patient with chalazia in the upper and lower lids: a case report. Srinivasan S, Menzies KL, Sorbara L, Jones LW Cont Lens Anterior Eye. 2013;36:199-203. doi: 10.1016/j.clae.2013.02.014. Epub 2013 Mar 29.

7. Meibomian gland dysfunction determines the severity of the dry eye conditions in visual display terminal workers. Wu H, Wang Y, Dong N, Yang F, Lin Z, Shang X, Li C PLoS One. 2014;9:e105575. doi: 10.1371/journal.pone.0105575

55

8. Noninvasive Keratograph assessment of tear film break-up time and location in patients with age-related cataracts and dry eye syndrome. Jiang Y, Ye H, Xu J, Lu Y J Int Med Res. 2014;42:494-502. doi: 10.1177/0300060513504701. Epub 2014 Jan 20

9. Evaluation of Meibomian Gland Dysfunction and Local Distribution of Meibomian Gland Atrophy by Non-contact Infrared Meibography. Finis D, Ackermann P, Pischel N, König C, Hayajneh J, Borrelli M, Schrader S, Geerling G. Curr Eye Res. 2014 Oct 20:1-8. [Epub ahead of print]

10. Meibomian gland dropout in patients with dry eye disease in China. Feng Y1, Gao Z, Feng K, Qu H, Hong J. Curr Eye Res. 2014;39:965-972. doi: 10.3109/02713683.2014.891748. Epub 2014 Jul 22.

2013

11. [Characterisation of tear film dynamics after application of trehalose for treatment of dry eye]. Ramoth T, Hovakimyan M, Guthoff RF, Stachs O. Klin Monbl Augenheilkd. 2013;230:1220-1224. doi: 10.1055/s-0033-1351069. Epub 2013 Dec 10. German.

2012

12. Infrared imaging of meibomian gland structure using a novel keratograph. Srinivasan S, Menzies K, Sorbara L, Jones L Optom Vis Sci. 2012;89:788-794. doi: 10.1097/OPX.0b013e318253de93.

This work was supported with an educational grant fromOCULUS Asia Ltd., Hong Kong

[email protected]

69/0

915/

EN/L

A

P/SD

/037

/EN

Date post:	10-Dec-2016
Category:	Documents
Upload:	hanga
View:	292 times
Download:	3 times

A Guide to Comprehensive Dry Eye Diagnostics with the OCULUS ...

Documents