10/3/2013 1 GLAUCOMA SURGERY: NEW SURGICAL TECHNIQUES RONALD L. GROSS, MD ASORN AAO 2013 WVU EYE INSTITUTE 2013 I have the following financial interests or relationships to disclose: Alcon Allergan Merck Alacrity Biosciences Mati Therapeutics Financial Disclosure Ronald L. Gross, MD Trabectome® Minimally Invasive Surgical management of Glaucoma BACKGROUND • Equipment System & Single Use pack – Trabectome System - I/A & Electrosurgery - easily integrated into Phaco unit – Special Goniolens – Procedure Packs Equipment System Procedure Pack ANGLE ANATOMY Scleral spur
Transcript
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GLAUCOMA SURGERY:NEW SURGICAL
TECHNIQUES
RONALD L. GROSS, MD
ASORN AAO 2013
WVU EYE INSTITUTE 2013
I have the following financial interests or relationships to disclose:
Alcon
Allergan
Merck
Alacrity Biosciences
Mati Therapeutics
Financial DisclosureRonald L. Gross, MD Trabectome®
Minimally Invasive Surgical management of Glaucoma
BACKGROUND• Equipment System & Single Use pack
– Trabectome System - I/A & Electrosurgery - easily integrated intoPhaco unit
– Special Goniolens– Procedure Packs
Equipment SystemProcedure Pack
ANGLE ANATOMY
Scleral spur
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ANGLE ANATOMY
Scleral spur
Schwalbe’s line
SCHLEMM’S CHANNEL ~ 350-500µM WIDTH
• Primary resistance to outflow: juxtacannalicular connective tissues & inner wall of Schlemm’s
• ~ 8 collector channels (aqueous veins) drain directly into episcleral venous plexus, most inferior nasally [Ascher1942]
• Per Elke Luetjen-Drecoll: The collector channels & aqueous veins have a rich innervation and smooth muscle intheir walls as do both surrounding arteries and veins
Bron AJ, Tripathi RC, Tripathi BJ: Wolff’s Anatomy Eye and Orbit 8 th Ed;1997 (pg 292 & 298).
SCHLEMM’S CHANNEL AND OUTFLOWPATHWAYS
Image courtesy of Jocson
BLOOD REFLUX IN SCHLEMM’S CHANNEL
Image courtesy of Masahiro Maeda, MD
TRABECTOME SURGICAL SYSTEM HANDPIECE TIP INSIDE EYE
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POSITION AND SETUP
Similar to Phaco Patient Set -up.
30o Microscope tilt toward surgeon
Near axial microscope ocularalignment
Rotate patient’s head away asneeded to maximize gonioscopic view
• Does not preclude subsequent surgery (spares conjunctiva)
TRABECTOME+PHACO VS.TRABECULECTOMY + PHACO
Combined Trabectome and Cataract Surgeryversus Combined Trabeculectomy andCataract Surgery in Open-Angle Glaucoma
Brian A. Francis, MD, MS; Jonathan Winarko, MDUniversity of Southern California, Keck School of Medicine, Los Angeles, CA
Clinical & Surgical Ophthalmology 29:2/3, 2011
STUDY DESIGN
• Prospective, non-randomized, comparative trial
• Consecutive patients, 1 surgeon
• 2 Groups:
– Trabectome + PCE (N=89)
– Trabeculectomy + PCE (N=23)
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IOP COMPARISON
Trabectome + PCE Trabeculectomy + PCE
MEDICATION USE COMPARISON
Trabectome + PCE Trabeculectomy + PCE
TRABECTOME VS.TRABECTOME + PHACO
Experience with Trabectomein Adult Open Angle GlaucomaPatients followed for at LeastOne YearSameh Mosaed, Douglas J. Rhee, TheodorosFilippopoulos, Helen Tseng, Sunil Deokule, andRobert N Weinreb
Clinical & Surgical Ophthalmology 28:8, 2010
STUDY DESIGN
• Consecutive patients of three (3) surgeons
• 2 Groups:
– Trabectome (N=538)
– Trabectome + PCE (N=290)
IOP
Trabectome+PCE Trabectome Alone
MEDICATION USE
Trabectome+PCE Trabectome Alone
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TRABECTOME ONLY VS TRABECTOME+PCESURVIVAL CURVE
Trabectome alone 64.9%
Trabectome+PCE 86.9%
Success definition:No additional glaucoma surgery and
IOP reduction ≥20% from pre-op and IOP <21 mmHglast 2 follow ups, after 3 months post-op
GLAUCOMA OVERVIEW• Glaucoma is one of the leading causes of blindness and is prevalent in the aging
US population
• Characterized by optic nerve damage and associated visual field loss
• Primary open-angle glaucoma (POAG) is the most common form of glaucoma
• Elevated IOP (ocular hypertension) is caused by resistance to aqueous humoroutflow in the trabecular meshwork
• Elevated IOP is the primary risk factor for glaucoma
• Glaucoma therapy must control both the level and fluctuation of IOP forimproved outcomes
• Surgical intervention in early stage patients may be beneficial in reducing therisk for vision loss due to glaucoma
CURRENT POAG TREATMENT
Newly DiagnosedPOAG Patient
Add MoreRx Therapy
Prescription Therapy(30 – 90 Days)
Switch or AddRx Therapy
LaserTrabeculoplasty
Invasive SurgeryTrabeculectomy
Drug therapy has been thestandard of care in glaucoma forover 30 years.Up to 80% of patients are taking2 medications increasing thedisease management challengesof glaucoma and financial burdento patients and the healthcaresystem.
AAO Preferred Practice Pattern; Primary Open Angle Glaucoma. AAO committee 2003.Stein J, Newman-Casey P, Niziol L, et. al. Association between the use of glaucoma medications andmortality. Arch Ophthalmol. 2010;128(2):235-245.
CHANGING POAG TREATMENT
Early StagePOAG Patient
Prescription Therapy1 or More Meds
Reduce IOP andMedication Use toSustain Target Pressure
Consider patient factors such as lifestyle, costs, andco-existing conditions when selecting glaucomatherapy. Factors such as noncompliance can have aneffect on clinical outcomes.
For patients undergoing cataract surgery, minimallyinvasive combination procedures that lower IOP andreduce medication dependence are practical andsustainable treatments for early diseasemanagement.
AAO Preferred Practice Pattern; Primary Open Angle Glaucoma. AAO committee 2003.Vizzeri G, Weinreub R.. Cataract surgery and glaucoma. Curr Opin Ophthalmol . 2010;128(2):235-240.
Minimally InvasiveCombo CataractProcedure
Combo CataractPOAG Patient
Opportunity to ReduceIOP and Medication Use
Comorbid Cataract and Glaucoma
Patients withCataract
Patients withCataract andGlaucoma
GLAUCOMA AND CATARACT
Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br JOphthalmol. 2006;90(3):262-7.Salmon JF.Chapter 11. Glaucoma, Vaughan & Asbury's General Ophthalmology.Kwon, Y. H., J. H. Fingert, et al. (2009). Primary open-angle glaucoma. N Engl J Med 360(11): 1113-24.Centers for Medicare and Medicaid Services. 2002 – 2007. Medicare Standard Analytical File.Baltimore, MD. 2007.
20.5%
79.5%
>650,000 of comorbid cases
Of the 3.3 million annual cataract proceduresperformed in the US, 20.5% of patients have
comorbid glaucoma and/or OHT
Global Incidence of Glaucoma
• Glaucoma will affect more than60.5 million people by 2010 andnearly 80 million people by 2020.
US Incidence Glaucoma• An estimated 3 to 6 million
people have glaucoma or ocularhypertension.
• Primary open-angle glaucoma(POAG) is the most commonform of glaucoma and the 2nd
leading cause of blindness.
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ISTENT® TRABECULAR MICRO-BYPASS
The only currently FDA approved device for thetreatment of mild-to-moderate open-angle glaucoma
• Falls into the “MIGS” category• Improves aqueous outflow through the natural
physiologic pathway• Reduces IOP• Inserted ab interno through the phaco incision• Can be performed under topical anesthesia• Overall safety profile similar to cataract surgery alone• Spares conjunctival tissue• Preserves potential for future treatment options
ISTENT® SPECIFICATIONS
• iStent dimensions are customized for a natural fit within the 270µm canal space
• Made of surgical-grade nonferromagnetic titanium
• Heparin-coated to promote self-priming
iStent is the smallest medical device known to be implanted in thehuman body and weighs just 60 µg
Self-Trephining Tip
Snorkel0.3 mm
Lumen 120 µm
iStent is designed for instinctive controlOne iStent system is comprised of a preloaded stent in
a single-use, sterile inserter with a secure rotatable grip
The inserter has reacquisition capability to facilitatemanipulation and placement into Schlemm’s canal
Customized iStent configurations
Two configurations of the iStent are available, one for theright eye (OD) and one for the left eye (OS)
The iStent is inserted ab interno through the phacoincision and can be performed under topical anesthesia
ISTENT® SYSTEM
Zhou, J. and G. T. Smedley. Trabecular bypass: effect of schlemm canal and collector channel dilation . JGlaucoma .2006;15(5):446-55.
Left Right
• Abnormality of the trabecularmeshwork (TM) is the primarysource of elevated intraocularpressure (IOP) in open-angleglaucoma
• 50-75% of total resistance toaqueous humor outflow is foundin the juxtacanalicular tissue ofthe TM
• Bypassing the TM allows accessto Schlemm’s canal and thedistal system in order to improveaqueous outflow through theconventional outflow pathways
Primary Source of Resistance:Diseased Trabecular Meshwork
Grant WM. Further studies on facility of flow through the trabecular meshwork. ArchOphthalmol.1958;60(4 )1:523-33.
Rosenquist R, et al. Outflow resistance of enucleated human eyes at two different perfusion pressuresand different extents of trabeculotomy. Curr Eye Res. 1989;(12):1233-40.Johnson DH, Johnson M. How does non-penetrating glaucoma surgery work? Aqueous outflow
resistance and glaucoma surgery. J Glaucoma.2001;10:55-67.
ISTENT® MAXIMIZES OUTFLOWTHROUGH A SINGLE BYPASS
Improve outflow and reduce IOP
iStent improvesaqueous outflow bycreating a patentbypass between theanterior chamber andSchlemm’s canal
iStent in the trabecular meshwork
Bahler CK, Smedley GT, Zhou J, Johnson DH. Trabecular bypass stents decrease intraocular pressure incultured human anterior segments. Am J Ophthalmol. 2004 Dec;138(6):988-94
ISTENT® PIVOTAL US IDE TRIALProspective, randomized, multi-centered study of POAG patients whounderwent iStent + cataract surgery vs. cataract surgery (CE) alone
290 subjects at 29 sites
240 randomized subjects with cataract and mild-to-moderate OAG
(1:1 randomization)
50 additional non-randomized subjects for safety
Patient population
Mild-to-moderate POAG (also PXE and PDS)
IOP ≤ 24 mm Hg on 1-3 medications
Post-medication washout IOP 22 – 36 mm Hg
Efficacy endpoints
Primary: IOP ≤ 21 mm Hg without medications at month 12
Secondary: IOP reduction ≥ 20% without medications at month 12
Follow-up through 2 years postoperative
Samuelson TW. Prospective randomized trial of cataract surgery with iStent implantation and cataractsurgery alone in mild-moderate open-angle glaucoma. Paper presented at: American Academy ofOphthalmology Annual Meeting; October 2009; San Francisco, CA.
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0
20
40
60
80
12 Months
iStent + Cataract
Cataract
ISTENT® PIVOTAL US IDE TRIAL
p = .004
%ey
es
Primary Endpoint≤ 21 mm Hg IOP with no medications
68%
50%67%
48%
18% more patients with CE plus iStent achieved targetpressures of ≤ 21 mm Hg with no medications
iStent® Trabecular Micro-Bypass Stent, Glaukos® Corporation; Directions for Use, Part # 45-0074
17% more patients with CE plus iStent achieved ≥20% reduction in IOP with no medications
ISTENT® PIVOTAL US IDE TRIAL
0
10
20
30
40
50
60
70
12 Months
iStent + Cataract
Cataract
Secondary Endpoint≥ 20% IOP reduction with no medications
p = .010
64%
47%
iStent® Trabecular Micro-Bypass Stent, Glaukos® Corporation; Directions for Use, Part # 45-0074
%ey
es
ISTENT® PIVOTAL US IDE TRIAL -IOP AND MEDICATION REDUCTION
At 12 months:
• >30% reduction from baseline IOP
• similar outcome validated adherence to the
study design (manage to threshold IOP)
• For iStent subjects, IOP reduction with
significantly less (P=0.001) medication:
• 15% of iStent vs. 35% cataract group on
medication
15%
35%
Samuelson TW, Katz LJ, Wells JM, et al. Randomized evaluation of the trabecular micro-bypass stentwith phacoemulsification in patients with glaucoma and cataract. Ophthalmology. 2011;118:459-467
.
FREQUENTLY REPORTEDADVERSE EVENTS
iStent® + cataract surgeryN=116 n(%)
Cataract surgeryonly N=117 n(%)
Early postoperative corneal edema 9 (8%) 11 (9%)
Any BCVA loss of at least one line at orafter the 3 month visit 8 (7%) 12 (10%)
Posterior capsular opacification 7 (6%) 12 (10%)
Stent obstruction 5 (4%) 0 (0%)
Blurry vision or visual disturbance 4 (3%) 8 (7%)
Elevated IOP 4 (3%) 5 (4%)
Excerpts from complete listing of safety population
iStent® Trabecular Micro-Bypass Stent, Glaukos® Corporation; Directions for Use, Part # 45-0074
Comparable overall safety profile
PATIENT HEAD & MICROSCOPE
• Patient head isturned away fromyou > 35⁰
• Microscope headis tilted toward you> 35⁰
The iStent injector is a sterile, single-use system, pre-loaded with oneiStent designed to deliver into Schlemm’s canal through the trabecularmeshwork
• The iStent® is inserted ab interno through the clear, cornea phaco-incision and can be performed under topical anesthesia
• The physiological preservation of the trabecular meshwork ensures anatural episcleral back pressure of 8 to 11 mm Hg, ensuring minimalto no risk for hypotony
ISTENT® SURGICAL PROCEDURE
4. Rosenquist R, Epstein D, Melamed S, et al. Outflow resistance of enucleated human eyes at twodifferent perfusion pressures and different extents of trabeculotomy. Curr Eye Res1989;8:1233-40.
• iStent® rails are seated against scleral wall of Schlemm’s canal
• iStent® Snorkel sits parallel to the iris plane
iStent® Surgical Procedure
ISTENT® SURGICAL PROCEDURE CLINICAL EXPERIENCECumulative human experience
Over 4000 subjects have been implanted to date
Clinical experience in US and OUS studies demonstrate IOP andmedication reduction with an overall favorable safety profile
iStent® Surgery iStent® Surgery
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130 lens
RetCam IntraoperativeGlaukos Procedure
ISTENTHandling Reminders
• Do not open the iStent box until cataract surgery is successfully completed ANDthe Dr. has checked the anterior chamber angle for good visualization
• After opening the box check to confirm the stent is on the tip of the insertiondevice
• Peel back and hold open for scrub to take out by the pinch slots - never drop ontotray – treat the iStent inserter like a diamond blade
• Squeezing the pinch slots releases tension on the insertion device
Tray reminders:
• Gonioprism• Miotic (Miochol/miostat)• Extra cohesive viscoelastic• Micro-forceps
