1. 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

2. 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

3. Why do I still do some form of Trabeculectomy? Experience … stood the test of time It works Can repeat it Doing it better EXP11749SK

4. 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 EXP11749SK Lichter PR, Musch DC, Gillespie BW, et al; CIGTS Study Group. Ophthalmology. 2001;

5. What counts in glaucoma surgery… “Is Scoring With Efficacy” IOP Reduction of 30% and More… EXP11749SK

6. Trab: Nothing else stacks up! Failed Contenders Viscocanalostomy Deep sclerectomy Deep sclerectomy with Aquaflow Sinusotomy Thermal sclerostomy Iridencleisis Laser sclerostomy Internal sclerectomy Cyclodialysis Trabeculotomy Goniotomy Cyclophotocoagulation Transscleral Endoscopic EXP11749SK

7. Trab’s Two Biggest Contenders: Tube Shunts Canaloplasty EXP11749SK

8. Trabeculectomy …a life after TVT? Tube vs Trab Study A new Star? Or tubes just on a Power Play? EXP11749SK

9. Trabeculectomy …a life after TVT? Study limitations –Preliminary data –More data being published 5yr results presented at AGS EXP11749SK

10. TUBE VS TRAB: SOME BOOTH COMMENTARY… Listen to me... I’m a Canadian! EXP11749SK

11. TVT Probability of Failure 30.7% 15.1% p = 0.010 EXP11749SK Gedde SJ et al. TVT 3 yr follow up, AJO 2009

12. TVT Probability of Failure 30.7% 15.1% p = 0.010 EXP11749SK Gedde SJ et al. TVT 3 yr follow up, AJO 2009

13. The Fight Wasn’t Fair! While all eyes were good candidates for a tube ….Failed trab eyes not good cases for another trab EXP11749SK

14. 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! EXP11749SK Gedde SJ et al. TVT 3 yr follow up, AJO 2009

15. TVT: The Off Sides Tube first … Big Bloody Operation One Good Shot Trab after a tube?? EXP11749SK

16. TVT: The Penalty Box! New motility problems in tube group 10% EXP11749SK Gedde SJ et al. TVT 3 yr follow up, AJO 2009

17. 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

18. Canaloplasty? Best study: 89 patients 3-year F/U Pre-op IOP: 23.5 mmHg Post-op IOP:15.5 mmHg 34% reduction EXP11749SK Lewis, RA, et al, Canaloplasty: 3 yr results, Journal of Cataract and Refractive Surgery 2011

19. 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

20. Canaloplasty vs TrabeculectomySponsori-ScienceCIGTS NIH NIH Patients (#) 89465 F/U (yrs) 35 IOP reduction 34%44% EXP11749SK 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;

21. So for that super-LOW IOP In Primary Virgin Eyes For now… EXP11749SK

22. Trabeculectomy is the Gold Standard! Trab… The Winning play!!! EXP11749SK

23. …but live with this!? EXP11749SK

24. …and this EXP11749SK

25. … 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

26. Mastering water-tight closure Condon Conj Closure video: Eyetube.net EXP11749SK

27. 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

28. More precision? More control? Maris, Ishida and Netland. J Glaucoma, Jan 2007 Hearndon and Marzette. AGS 2008 EX-PRESS® device under scleral flap EXP11749SK

29. Postoperative Complications EX-PRESS ® Device TrabP-value Early Hypotony* 4%32% < 0.001 Choroidal Effusion 8%38% < 0.001 * Early hypotony = IOP ≤ 4 mmHg during first postoperative week. No other complications were significantly different in comparisons between groups. Maris, Ishida, Netland. J Glaucoma, Jan 2007 EXP11749SK

30. Trab-what I hated EXP11749SK

31. EX-PRESS® device titled 220 EXP11749SK

32. EX-PRESS® Device: P-50 EXP11749SK

33. EX-PRESS® device P-50 DETAIL EXP11749SK

34. Mastering water-tight closure Condon Conj Closure video: Eyetube.net EXP11749SK

35. My Flap Technique Conj flap technique:Limbus- Based <2001 Fornix- Based >2001 Number of consec eyes: (min 4 wk f/up) 107199 wound leaks req surg repair:22 wound leaks req surg repair %1.91.0 Video: ‘Closing the Conjunctival Flap’ www.Eyetube.net EXP11749SK

36. 1 mo 1 yr EXP11749SK

37. 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

38. 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

39. Assessment of Visual Recovery EX-PRESS® device Versus Trabeculectomy * Best Corrected EXP11749SK

40. EX-PRESS® Glaucoma Filtration Device Remarkably Biocompatible EXP11749SK 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

41. Defeo et al. 2009 Fine layer of fibrous tissue devoid of inflammatory components EXP11749SK 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

42. 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 EXP11749SK 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

43. EX-PRESS® Glaucoma Filtration Device After failed tube… EXP11749SK

44. We can do BETTER than this! EXP11749SK

45. And this… EXP11749SK

46. 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

47. Thank-you EXP11749SK