Stanislao Rizzo1, Pierre-Olivier Barale2,3, Sarah Ayello-Scheer3, Robert G Devenyi4,5, Marie-Noëlle Delyfer6,7, Jean-François Korobelnik6,7, Aleksandra Rachitskaya8, Alex Yuan8, K Thiran Jayasundera9, David N Zacks9, James T Handa10, Sandra R Montezuma11, Dara Koozekanani11, Paulo E Stanga12, Lyndon da Cruz13, Peter Walter14, Albert J Augustin15, Marzio Chizzolini16, Lisa C Olmos de Koo17, Allen C Ho18, Bernd Kirchhof19, Paul Hahn20, Lejla Vajzovic21, Raymond Iezzi22, David Gaucher23,24, J Fernando Arevalo10, Ninel Z Gregori25, Salvatore Grisanti26, Emin Özmert27, Young Hee Yoon28, Gregg T Kokame29, Jennifer I Lim30, Peter Szurman31, Eugene de Juan32, Flavio A Rezende33, Joël Salzmann34, Gisbert Richard35, Suber S Huang36, Francesco Merlini37, Uday Patel37, Cynthia Cruz37, Robert J Greenberg37, Sally Justus38, Laura Cinelli1, Mark S Humayun39,40. 1. Azienda Ospedaliera Universitaria Careggi, Department of Medicine and Translational Surgery, University of Florence, Florence, Italy. 2. Sorbonne University, UPMC Univ Paris 06, INSERM U968, CNRS UMR 7210, Institute of Vision, Paris, France. 3. CHNO des Quinze-Vingts, DHU Sight Restore, INSERM-DGOS CIC 1423, Paris, France. 4. Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada. 5. Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada. 6. Inserm, Bordeaux Population Health Research Center, Team LEHA, University of Bordeaux, Bordeaux, France. 7. Department of Ophthalmology, Bordeaux University Hospital, Bordeaux, France. 8. Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio. 9. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan. 10. The Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland. 11. Department of Ophthalmology and Visual Neurosciences, University of Minnesota, Minneapolis, Minnesota. 12. Manchester Vision Regeneration (MVR) Lab, Manchester Royal Eye Hospital, NIHR Manchester Clinical Research Facility and Manchester University NHS Foundation Trust, Manchester, United Kingdom. 13. NIHR Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital, London, United Kingdom. 14. Department of Ophthalmology, RWTH Aachen University, Aachen, Germany. 15. Department of Ophthalmology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany. 16. Unità Operativa Complessa di Oculistica, Camposampiero-Cittadella (Padova), Padua, Italy. 17. Department of Ophthalmology, UW Medicine Eye Institute, University of Washington, Seattle, Washington. 18. The Retina Service of Wills Eye Hospital, Mid Atlantic Retina, Philadelphia, Pennsylvania, Pennsylvania. 19. Department of Retina and Vitreous Surgery, Center of Ophthalmology, University of Cologne, Cologne, Germany. 20. New Jersey Retina, Teaneck, New Jersey. 21. Department of Ophthalmology, Duke University School of Medicine, Durham, North Carolina. 22. Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota, Minnesota. 23. Nouvel Hôpital Civil, University Hospitals of Strasbourg, Strasbourg, France. 24. Laboratory of Bacteriology (EA- 7290), The Federation of Translational Medicine of Strasbourg, University of Strasbourg, Strasbourg, France. 25. Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami. 26. Department of Ophthalmology, University of Luebeck, UKSH Luebeck, Germany. 27. Department of Ophthalmology, Ankara University Faculty of Medicine, Ankara, Turkey. 28. Department of Ophthalmology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. 29. Retina Consultants of Hawaii, Aiea, Hawaii. 30. Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, Illinois. 31. Knappschaft Eye Clinic Sulzbach, Knappschaft Hospital Saar, Sulzbach/Saar, Germany. 32. ForSight Labs, Menlo Park, California. 33. Department of Ophthalmology, Hôpital Maisonneuve-Rosemont, University of Montreal, Montreal, Québec, Canada. 34. Department of Ophthalmology, Clinique Générale-Beaulieu, Geneva, Switzerland. 35. Department of Ophthalmology, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany. 36. Retina Center of Ohio, South Euclid, Ohio. 37. Second Sight Medical Products, Inc, Sylmar, California. 38. Harvard Medical School, Boston, Massachusetts. 39. USC Institute for Biomedical Therapeutics, USC Roski Eye Institute, University of Southern California, Los Angeles, California; and. 40. Department of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles, California.
Abstract
PURPOSE: To analyze and provide an overview of the incidence, management, and prevention of conjunctival erosion in Argus II clinical trial subjects and postapproval patients. METHODS: This retrospective analysis followed the results of 274 patients treated with the Argus II Retinal Prosthesis System between June 2007 and November 2017, including 30 subjects from the US and European clinical trials, and 244 patients in the postapproval phase. Results were gathered for incidence of a serious adverse event, incidence of conjunctival erosion, occurrence sites, rates of erosion, and erosion timing. RESULTS: Overall, 60% of subjects in the clinical trial subjects versus 83% of patients in the postapproval phase did not experience device- or surgery-related serious adverse events. In the postapproval phase, conjunctival erosion had an incidence rate of 6.2% over 5 years and 11 months. In 55% of conjunctival erosion cases, erosion occurred in the inferotemporal quadrant, 25% in the superotemporal quadrant, and 20% in both. Sixty percent of the erosion events occurred in the first 15 months after implantation, and 85% within the first 2.5 years. CONCLUSION: Reducing occurrence of conjunctival erosion in patients with the Argus II Retinal Prosthesis requires identification and minimization of risk factors before and during implantation. Implementing inverted sutures at the implant tabs, use of graft material at these locations as well as Mersilene rather than nylon sutures, and accurate Tenon's and conjunctiva closure are recommended for consideration in all patients.
PURPOSE: To analyze and provide an overview of the incidence, management, and prevention of conjunctival erosion in Argus II clinical trial subjects and postapproval patients. METHODS: This retrospective analysis followed the results of 274 patients treated with the Argus II Retinal Prosthesis System between June 2007 and November 2017, including 30 subjects from the US and European clinical trials, and 244 patients in the postapproval phase. Results were gathered for incidence of a serious adverse event, incidence of conjunctival erosion, occurrence sites, rates of erosion, and erosion timing. RESULTS: Overall, 60% of subjects in the clinical trial subjects versus 83% of patients in the postapproval phase did not experience device- or surgery-related serious adverse events. In the postapproval phase, conjunctival erosion had an incidence rate of 6.2% over 5 years and 11 months. In 55% of conjunctival erosion cases, erosion occurred in the inferotemporal quadrant, 25% in the superotemporal quadrant, and 20% in both. Sixty percent of the erosion events occurred in the first 15 months after implantation, and 85% within the first 2.5 years. CONCLUSION: Reducing occurrence of conjunctival erosion in patients with the Argus II Retinal Prosthesis requires identification and minimization of risk factors before and during implantation. Implementing inverted sutures at the implant tabs, use of graft material at these locations as well as Mersilene rather than nylon sutures, and accurate Tenon's and conjunctiva closure are recommended for consideration in all patients.