Allen C Ho1, Mark S Humayun2, Jessy D Dorn3, Lyndon da Cruz4, Gislin Dagnelie5, James Handa5, Pierre-Olivier Barale6, José-Alain Sahel7, Paulo E Stanga8, Farhad Hafezi9, Avinoam B Safran10, Joel Salzmann11, Arturo Santos12, David Birch13, Rand Spencer14, Artur V Cideciyan15, Eugene de Juan16, Jacque L Duncan16, Dean Eliott17, Amani Fawzi18, Lisa C Olmos de Koo2, Gary C Brown19, Julia A Haller20, Carl D Regillo19, Lucian V Del Priore21, Aries Arditi22, Duane R Geruschat5, Robert J Greenberg3. 1. Wills Eye Hospital, Philadelphia, Pennsylvania. Electronic address: acho@midatlanticretina.com. 2. University of Southern California, Los Angeles, California. 3. Second Sight Medical Products, Sylmar, California. 4. Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom; NHIR Moorfields Biomedical Research Centre, London, United Kingdom. 5. Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland. 6. Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris, France. 7. Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris, France; ELZA Institute, Zurich, Switzerland. 8. Manchester Royal Eye Hospital, Manchester, United Kingdom; Manchester Vision Regeneration Lab at National Institute for Health Research/Wellcome Trust Manchester CRF, Manchester, United Kingdom; Manchester Academic Health Science Centre and Centre for Ophthalmology and Vision Research, Institute of Human Development, University of Manchester, Manchester, United Kingdom. 9. University of Southern California, Los Angeles, California; Hôpitaux Universitaires de Genève, Geneva, Switzerland; ELZA Institute, Zurich, Switzerland. 10. Hôpitaux Universitaires de Genève, Geneva, Switzerland; Sorbonne Universities - UPMC Paris-6, and Institut de la Vision, Paris, France. 11. Hôpitaux Universitaires de Genève, Geneva, Switzerland. 12. Centro de Retina Medica y Quirúrgica, SC, Guadalajara, Mexico; Tecnologico de Monterrey, Guadalajara, Mexico. 13. Retina Foundation of the Southwest, Dallas, Texas. 14. Texas Retina Associates, Dallas, Texas. 15. Scheie Eye Institute, University of Pennsylvania, Philadelphia, Pennsylvania. 16. University of California, San Francisco, San Francisco, California. 17. University of Southern California, Los Angeles, California; Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, Massachusetts. 18. University of Southern California, Los Angeles, California; Feinberg School of Medicine, Northwestern University, Chicago, Illinois. 19. Wills Eye Hospital, Philadelphia, Pennsylvania. 20. Wills Eye Hospital, Philadelphia, Pennsylvania; Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland. 21. Columbia University, New York, New York; Storm Eye Institute, Charleston, South Carolina. 22. Lighthouse Guild, New York, New York; Visibility Metrics, LLC, Chappaqua, New York.
Abstract
PURPOSE: Retinitis pigmentosa (RP) is a group of inherited retinal degenerations leading to blindness due to photoreceptor loss. Retinitis pigmentosa is a rare disease, affecting only approximately 100 000 people in the United States. There is no cure and no approved medical therapy to slow or reverse RP. The purpose of this clinical trial was to evaluate the safety, reliability, and benefit of the Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) in restoring some visual function to subjects completely blind from RP. We report clinical trial results at 1 and 3 years after implantation. DESIGN: The study is a multicenter, single-arm, prospective clinical trial. PARTICIPANTS: There were 30 subjects in 10 centers in the United States and Europe. Subjects served as their own controls, that is, implanted eye versus fellow eye, and system on versus system off (native residual vision). METHODS: The Argus II System was implanted on and in a single eye (typically the worse-seeing eye) of blind subjects. Subjects wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. MAIN OUTCOME MEASURES: The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests. RESULTS: A total of 29 of 30 subjects had functioning Argus II Systems implants 3 years after implantation. Eleven subjects experienced a total of 23 serious device- or surgery-related adverse events. All were treated with standard ophthalmic care. As a group, subjects performed significantly better with the system on than off on all visual function tests and functional vision assessments. CONCLUSIONS: The 3-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind from RP. Earlier results from this trial were used to gain approval of the Argus II by the Food and Drug Administration and a CE mark in Europe. The Argus II System is the first and only retinal implant to have both approvals.
PURPOSE:Retinitis pigmentosa (RP) is a group of inherited retinal degenerations leading to blindness due to photoreceptor loss. Retinitis pigmentosa is a rare disease, affecting only approximately 100 000 people in the United States. There is no cure and no approved medical therapy to slow or reverse RP. The purpose of this clinical trial was to evaluate the safety, reliability, and benefit of the Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) in restoring some visual function to subjects completely blind from RP. We report clinical trial results at 1 and 3 years after implantation. DESIGN: The study is a multicenter, single-arm, prospective clinical trial. PARTICIPANTS: There were 30 subjects in 10 centers in the United States and Europe. Subjects served as their own controls, that is, implanted eye versus fellow eye, and system on versus system off (native residual vision). METHODS: The Argus II System was implanted on and in a single eye (typically the worse-seeing eye) of blind subjects. Subjects wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. MAIN OUTCOME MEASURES: The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests. RESULTS: A total of 29 of 30 subjects had functioning Argus II Systems implants 3 years after implantation. Eleven subjects experienced a total of 23 serious device- or surgery-related adverse events. All were treated with standard ophthalmic care. As a group, subjects performed significantly better with the system on than off on all visual function tests and functional vision assessments. CONCLUSIONS: The 3-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind from RP. Earlier results from this trial were used to gain approval of the Argus II by the Food and Drug Administration and a CE mark in Europe. The Argus II System is the first and only retinal implant to have both approvals.
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