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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 PA. EXP11749SK. EX-PRESS ® Device Brief Statement.
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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 PA EXP11749SK
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. EXP11749SK
Why do I still do some form of Trabeculectomy? Experience …stood the test of time It works Can repeat it Doing it better EXP11749SK
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 Lichter PR, Musch DC, Gillespie BW, et al; CIGTS Study Group. Ophthalmology. 2001; EXP11749SK
What counts in glaucoma surgery…“Is Scoring With Efficacy” IOP Reduction of 30% and More… EXP11749SK
Failed Contenders Viscocanalostomy Deep sclerectomy Deep sclerectomy with Aquaflow Sinusotomy Thermal sclerostomy Iridencleisis Laser sclerostomy Internal sclerectomy Cyclodialysis Trabeculotomy Goniotomy Cyclophotocoagulation Transscleral Endoscopic Trab: Nothing else stacks up! EXP11749SK
Trab’sTwo Biggest Contenders: Tube Shunts Canaloplasty EXP11749SK
Trabeculectomy …a life after TVT? Tube vsTrab Study A new Star? Or tubes just on a Power Play? EXP11749SK
Trabeculectomy …a life after TVT? • Study limitations • Preliminary data • More data being published • 5yr results presented at AGS EXP11749SK
Listen to me... I’m a Canadian! Tube VS Trab:some booth commentary… EXP11749SK
TVT Probability of Failure 30.7% p = 0.010 15.1% Gedde SJ et al. TVT 3 yr follow up, AJO 2009 EXP11749SK
TVT Probability of Failure 30.7% p = 0.010 15.1% Gedde SJ et al. TVT 3 yr follow up, AJO 2009 EXP11749SK
The Fight Wasn’t Fair! While all eyes were good candidates for a tube ….Failed trab eyes not good cases for another trab EXP11749SK
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! Gedde SJ et al. TVT 3 yr follow up, AJO 2009 EXP11749SK
TVT: The Off Sides Tube first … Big Bloody Operation One Good Shot Trab after a tube?? EXP11749SK
TVT: The Penalty Box! New motility problems in tube group 10% Gedde SJ et al. TVT 3 yr follow up, AJO 2009 EXP11749SK
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. EXP11749SK
Canaloplasty? Best study: 89 patients 3-year F/U Pre-op IOP: 23.5 mmHg Post-op IOP:15.5 mmHg 34% reduction Lewis, RA, et al, Canaloplasty: 3 yr results, Journal of Cataract and Refractive Surgery 2011 EXP11749SK
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 Lewis, RA, et al, Canaloplasty: 3 yr results, Journal of Cataract and Refractive Surgery 2011 EXP11749SK
CanaloplastyvsTrabeculectomy Lewis, RA, et al, Canaloplasty: 3 yr results, Journal of Cataract and Refractive Surgery 2011 Lichter PR, Musch DC, Gillespie BW, et al; CIGTS Study Group. Ophthalmology. 2001; EXP11749SK
So for that super-LOW IOP In Primary Virgin Eyes For now… EXP11749SK
Trabeculectomy is the Gold Standard! Trab… The Winning play!!! EXP11749SK
…but live with this!? EXP11749SK
…and this EXP11749SK
… We CAN DO IT BETTER! Surgery 1 year apart OS limbal based OD fornix based • Fornix based flap • Broader MM-C application • Bullet-proof Conj closure EXP11749SK
Mastering water-tight closure Condon Conj Closure video: Eyetube.net EXP11749SK
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. EXP11749SK
More precision? More control? Maris, Ishida and Netland. J Glaucoma, Jan 2007 Hearndon and Marzette. AGS 2008 EX-PRESS® device under scleral flap EXP11749SK
Trab-what I hated EXP11749SK
EX-PRESS® device titled 220 EXP11749SK
EX-PRESS® Device: P-50 EXP11749SK
EX-PRESS® device P-50 DETAIL EXP11749SK
My Flap Technique Video: ‘Closing the Conjunctival Flap’ www.Eyetube.net EXP11749SK
1 mo 1 yr EXP11749SK
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 EXP11749SK
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) EXP11749SK
Assessment of Visual RecoveryEX-PRESS® device Versus Trabeculectomy * Best Corrected EXP11749SK
EX-PRESS® Glaucoma Filtration Device Remarkably Biocompatible • 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 EXP11749SK
De Feoetal. 2009 • 2 yr postop EX-PRESS® device in one eye (postmortem) • No difference in corneal endothelial cell density between the two eyes • 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 EXP11749SK
We can do BETTER than this! EXP11749SK
And this… EXP11749SK
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! EXP11749SK
Thank-you EXP11749SK