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

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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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