TrabectomeTM Perspectives Laboratory in vitro TrabectomeTM
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TrabectomeTM Perspectives Laboratory in vitro TrabectomeTM
TM Trabectome Clinical Results with the for treatment of Open-angle Glaucoma [In press: Ophthalmology; Dec. 2004] Don S. Minckler, MD,1 George Baerveldt, MD,2 Marina Ramirez Alfaro, MD,3 and Brian A. Francis, MD1 1Doheny Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, California. 2 University of California, Irvine, 3 Codet Eye Institute, Tijuana, Mexico TM Trabectome Goniotomy – Effective only in Children (Illustrations: Becker-Shaffer’s Diagnosis & Therapy of the Glaucomas 5th Ed., Mosby, 1983, page 494-5.) •View of Angle/Meshwork through surgical lens TrabectomeTM Anatomy of the Anterior Chamber Angle Pre-op IOP=28.2 ± 4.4 mmHg (n=42) 18 months post-op IOP = 16.0 ± 1.6 mmHg (n=11) 32 30 •Masson’s Trichrome 28 26 24 IOP (mmHg) 22 20 18 16 14 12 10 8 6 4 Trabeculotomy – Option when visualization poor Laboratory in vitro •Pseudoexfoliation: 8 •Pigment Dispersion: 2 •Steroid-induced: 1 •Previous trabeculectomy 1; pseudophakic 1 •Main difficulty is Identifying Schlemm’s •Possible conversion to trabeculectomy Becker-Shaffer’s Diagnosis & Therapy of the Glaucomas, 5th Ed., Mosby, 1983, page 475. •17 male & 20 female Hispanic/White adults age 61 + 11 years; failing medical therapy, healthy, COAG & sub-types: VFD/Disc advanced (C/D > 0.8 in 15; VFD in 3/4 quadrants in 27) •Inverted corneal donor rim in suction device •Initial lens status • Phakic without cataract: 24 •With mild cataract: 12 • No. of Meds. (pre op): 1.2 + 0.6 (n = 34 patients) • No. of Meds. (last visit): 0.13 + 0.6 (n = 14 patients) TrabectomeTM Console/handpiece Unroofed Schlemm’s TrabectomeTM Initial case series (first 37 patients) •Intraoperative blood reflux in all cases: •Hyphema cleared by 6.4 + 4.1 days •20% hyphema largest in this series •Minimized by wound suture/air tamponade •2% Pilocarpine pre-op & 2 – 6 weeks post-op •Transient Corneal injuries: 6/37 (16.2%) •Epithelial defect: 3/37 •Decemet’s hemorrhage: 1/37 •Decemet’s scroll/detach: 1/37 •Persisting Decemet’s injury: 1/37 (8.1%) (2.7%) (2.7%) (2.7%) •Partial PAS/goniosynechiae: 14/37 (38%) TrabectomeTM TrabectomeTM Perspectives •Potentially safer/easier than trabeculectomy •? Fits into therapeutic spectrum between laser and trabeculectomy •Potential alternative to goniotomy/trabeculotomy in children •Relatively easy skill transfer Surgical Data (extended to 42 patients) CB hinged forward See RF et al: ARVO 2003: A [control]; B [goniotomy]; C: confocal image after goniotomy; D: TrabectomeTM Pre-Op 1 day 7 day 1 month 3 months 6 months 9 months 12 months 18 months 28.2 mm Hg ± 4.3 18.3 mm Hg ± 10.6 17.8 mm Hg ± 5.8 17.1 mm Hg ± 5.4 17.9 mm Hg ± 4.1 17.6 mm Hg ± 3.4 15.8 mm Hg ± 2.6 16.3 mm Hg + 2.0 16.0 mm Hg + 1.6 n=42 n=42 n=42 n=42 n=42 n=31 n=26 n=19 n=11 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Months After Surge ry References: 1. Brubaker RF. Targeting outflow facility in glaucoma management. Surv Ophthalmol. 2003;Suppl 1:S17-20. 2. Lutjen-Drecoll E. Functional morphology of the trabecular meshwork in primate eyes. 1999:18:91-119. 3. Wormald R, Wiklins MR, Bunce C. Post-operative 5-fluorouracil for glaucoma surgery. The Cochrane Database of systematic reviews. Vol 1, 2003. 4. WuDunn D, Cantor LB, Palanca-Capistrano AM, Hoop J, Alvi NP, Finley C, Lakhani V, Burnstein A, Knotts SL. A prospective randomized trial comparing intraoperative 5fluorouracil vs mitomycin C in primary trabeculectomy. Am J Ophthalmol 2002;134:521-8. 5. Fluorouracil Filtering Surgery Study Group. Three-year follow-up of the Fluorouracil Filtering Surgery Study. Am J Ophthalmol 1991;115:82-92. 6. Kobayashi H, Kobayashi K, Okinami S. A comparison of the intraocular pressure-lowering effect and safety of viscocanalostomy and trabeculectomy with mitomycin C in bilateral open-angle glaucoma. Gravfes Arch Clin Exp Ophthalmol 2003;241:359-66. 7. Shaarawy T, Wu R, Mermoud A, Flammer J, Haefliger IO. Influence of non- penetrating glaucoma surgery on aqueous outflow facility in isolated porcine eyes. Br J Ophthalmol. 2004;88:950-2. 8. Johnson DH, Johnson M. Glaucoma surgery and aqueous outflow: how does nonpenetrating glaucoma surgery work? Arch Ophthalmol 2002;120(1):67-70. 9. Heuer DK, Lloyd MA, Abrams DA, Baerveldt G, Minckler DS, Lee MB, and Martone JF: Which is better? One or two? A randomized clinical trial of single-plate versus doubleplate Molteno implantation for glaucomas in aphakia and pseudophakia. Ophthalmology 1992;99:1512-1519. 10. Barkan O. Technique of goniotomy. Arch Ophthalmol 1938(19):217-21.11. 11.Gramer E, Tausch M, Kraemer C. Time of diagnosis, reoperations and long-term results of goniotomy in the treatment of primary congenital glaucoma: a clinical study. International Ophthalmology 1996;20(1-3):117-23. 12. Mendicino ME, Lynch MG, Drack A, et al. Long-term surgical and visual outcomes in primary congenital glaucoma: 360 degrees trabeculotomy versus goniotomy. Journal of American Association for Pediatric Ophthalmology & Strabismus 2000;4(4):205-10. 13. Ritch R, Shields MB, Krupin T, (Eds.) The Glaucomas, 2nd Ed., Dickens CH and Hoskins HDJr. Ch 33, Mosby, St Louis, 1996, page 729. 14. Hill RA, Baerveldt G, Ozler SA, Pickford M, Pfreta GA, Berns MW. Laser trabecular ablation. Laser Surg Med 1991;32:11:341-6. 15. Epstein DL, Melamed S, Puliafito CA, Steinert RF. Neodymium-YAG laser trabeculopuncture in open-angle glaucoma. Ophthalmology 1985;92:931-7. 16. Jacobi PC, Dietlein TS, Krieglstein GK. Technique of goniocurettage: a potential treatment for advanced chronic open-angle glaucoma. Brit J Ophthalmol 1997;81:302-7. 17. Spencer WH, (Ed) Ophthalmic Pathology An Atlas and Text, 3rd Ed, Ch 6, Glaucoma, W. B. Saunders, Philadelphia, 1985, page 481. 18. Rosenquist R, Epstein D, Melamed S, et al. Outflow resistance of enucleated human eyes at two different perfusion pressures and different extents of trabeculotomy. Curr Eye Res 1989;8(12):1233-40. 19. Kobayashi HK, Kobayashi K, Hosino T, Awaya S. Age-related changes of microfibrils in the cornea and trabecular meshwork of the human eye. Jpn J Ophthalmol 1991;35:16674. 20. Segawa K. Trabecular meshwork and elastin. Nippon Ganka Gakkai Zasshi 1995;99:1291-302. ACKNOWLEDGEMENTS: Supported in part by National Institutes of Health grants EY03040 and EY015037 and by an unrestricted grant from Research to Prevent Blindness, New York, New York and by NeoMedix Corporation.4