glaucoma surgery 2011: why am i still doing a trabeculectomy? garry p condon, md associate professor...
TRANSCRIPT
Glaucoma Surgery 2011:
Why am I Still Doing a Trabeculectomy?
Garry P Condon, MD
Associate Professor Ophthalmology
Drexel University College of Medicine
Chairman Dept Ophthalmology
Allegheny General Hospital
Pittsburgh PAEXP11749SK
EX-PRESS® Device Brief Statement
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
INDICATION: The EX-PRESS® Glaucoma Filtration Device is intended to reduce intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed.
GUIDANCE REGARDING THE SELECTION OF THE APPROPRIATE VERSION: Prior clinical studies were not designed to compare between the various versions of the EX-PRESS® Glaucoma Filtration Device. The selection of the appropriate version is according to the doctor's discretion.
CONTRAINDICATIONS: The use of this device is contraindicated if one or more of the following conditions exist:
· Presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis.
· Pre-existing ocular or systemic pathology that, in the opinion of the surgeon, is likely to cause postoperative complications following implantation of the device.
· Patients diagnosed with angle closure glaucoma.
WARNINGS/PRECAUTIONS:
· The surgeon should be familiar with the instructions for use.
· The integrity of the package should be examined prior to use and the device should not be used if the package is damaged and sterility is compromised.
· This device is for single use only.
· MRI of the head is permitted, however not recommended, in the first two weeks post implantation.
ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings, precautions, complications and adverse events.
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Why do I still do some form of Trabeculectomy?
Experience
…stood the test of time
It works
Can repeat it
Doing it better
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Collaborative Initial Glaucoma Treatment Study (CIGTS)
• 465 trabeculectomies (300 patients) • Pre-op IOP: 27 mmHg• Post-op IOP: 15 mmHg
– 44% reduction
• 5 years follow-up
EXP11749SKLichter PR, Musch DC, Gillespie BW, et al; CIGTS Study Group. Ophthalmology. 2001;
What counts in glaucoma surgery…
“Is Scoring With Efficacy”
IOP Reduction of
30% and More…
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Trab: Nothing else stacks up!
Failed ContendersViscocanalostomyDeep sclerectomyDeep sclerectomy with
AquaflowSinusotomyThermal sclerostomyIridencleisisLaser sclerostomyInternal sclerectomyCyclodialysisTrabeculotomyGoniotomyCyclophotocoagulation
TransscleralEndoscopic
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Trab’s Two Biggest Contenders:
Tube ShuntsCanaloplasty
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Trabeculectomy …a life after TVT?
Tube vs Trab Study
A new Star?
Or tubes just on a Power Play?
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Trabeculectomy …a life after TVT?
• Study limitations – Preliminary data– More data being published
• 5yr results presented at AGS
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TUBE VS TRAB:SOME BOOTH COMMENTARY…
Listen to me...I’m a Canadian!
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TVT Probability of Failure
30.7%
15.1%
p = 0.010
EXP11749SKGedde SJ et al. TVT 3 yr follow up, AJO 2009
TVT Probability of Failure
30.7%
15.1%
p = 0.010
EXP11749SKGedde SJ et al. TVT 3 yr follow up, AJO 2009
The Fight Wasn’t Fair!
While all eyes were good candidates for a tube
….Failed trab eyes not good cases for another trab
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And yet…The Overtime Period!
Trab was ‘effective’ in 70% of cases
And on fewer meds!
… available options down the road
Needling / revision
Trab again!
EXP11749SKGedde SJ et al. TVT 3 yr follow up, AJO 2009
TVT: The Off Sides
Tube first … Big Bloody Operation
One Good Shot
Trab after a tube??
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TVT: The Penalty Box!
New motility problems in tube group 10%
EXP11749SKGedde SJ et al. TVT 3 yr follow up, AJO 2009
Replay… what can we say?
• Do TVT results to date favor tubes?• Yes – In patients with previous conj surgery
But…• In Clear corneal pseudophakes?• In Primary glaucoma surgery??
We just don’t know.
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Canaloplasty?
Best study: 89 patients 3-year F/UPre-op IOP: 23.5 mmHgPost-op IOP:15.5 mmHg
34% reduction
EXP11749SKLewis, RA, et al, Canaloplasty: 3 yr results, Journal of Cataract and Refractive Surgery 2011
Canaloplasty: Problems No independent data…
Uncontrolled, non-randomized study from i-Science
And…15% of cases surgeons couldn’t
complete the operation!!Find the canal Pass the Microcatheter
EXP11749SKLewis, RA, et al, Canaloplasty: 3 yr results, Journal of Cataract and Refractive Surgery 2011
Canaloplasty vs Trabeculectomy
Sponsor i-Science CIGTS NIH
Patients (#)
89 465
F/U (yrs) 3 5
IOP reduction
34% 44%
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Lewis, RA, et al, Canaloplasty: 3 yr results, Journal of Cataract and Refractive Surgery 2011Lichter PR, Musch DC, Gillespie BW, et al; CIGTS Study Group. Ophthalmology. 2001;
So for that super-LOW IOP
In Primary Virgin Eyes
For now…
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Trabeculectomy is the Gold Standard!
Trab… The Winning play!!!
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…but live with this!?
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…and this
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… We CAN DO IT BETTER!
Surgery 1 year apart
OS limbal based OD fornix based
Fornix based flapBroader MM-C applicationBullet-proof Conj closure
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Mastering water-tight closure
Condon Conj Closure video: Eyetube.net
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EX-PRESS® Device Indication
The EX-PRESS® Glaucoma Filtration Device is intended to reduce intraocular pressure in
glaucoma patients where medical and conventional surgical treatments (SLT/ALT)
have failed.
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More precision?More control?
Maris, Ishida and Netland. J Glaucoma, Jan 2007
Hearndon and Marzette. AGS 2008
EX-PRESS® device under scleral flap
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Trab-what I hated
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EX-PRESS® device titled 220EXP11749SK
EX-PRESS® Device: P-50
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EX-PRESS® device P-50 DETAIL
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My Flap Technique
Conj flap technique: Limbus-Based <2001
Fornix-Based>2001
Number of consec eyes:(min 4 wk f/up)
107 199
wound leaks req surg repair: 2 2
wound leaks req surg repair % 1.9 1.0
Video: ‘Closing the Conjunctival Flap’www.Eyetube.net
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1 mo
1 yr
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Assessment of Bleb Morphology and Post-operative Outcomes After
EX-PRESS® device Versus Trabeculectomy(Good & Kahook, AJO 2011)
• Retrospective Consecutive Case Control Series
• Seventy Patients (n=35 each group) with Mean of ~28 months of follow up
• Also assessed time to visual recovery
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Post-operative Outcomes After EX-PRESS® device Versus Trabeculectomy
Final IOP decreased by 45.15% and 48.45% from baseline in the EX-PRESS® device and Trabeculectomy groups respectively (p=0.209)
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Assessment of Visual RecoveryEX-PRESS® device Versus Trabeculectomy
* Best CorrectedEXP11749SK
EX-PRESS® Glaucoma Filtration Device
Remarkably Biocompatible
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A Nyska, Y. Glovinsky, M. Belkin, and Y. Epstein. Biocompatibility of the EX-PRESS® miniature glaucoma drainage implant. J Glaucoma. 2003 Jun; 12(3):275-80
De Feo etal. 2009• 2 yr postop EX-PRESS® device in one eye
(postmortem)• No difference in corneal endothelial cell density
between the two eyes
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F. De Feo, S. Jacobson, A Nyska, P. Pagani, C.E Traverso. Histological Biocompatibility of a Stainless Steel Miniature Glaucoma Drainage Device in Humans: A Case Report. Toxicologic Pathology, 37: 512-516, 2009
We can do BETTER than this!
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And this…
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Let’s raise the bar…
More correct and effective standard surgery
New approaches to enhance current techniques
Smoother more favorable outcomes
No… Let’s Raise a Glass at the Bar!
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Thank-you
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