Lyndon da Cruz1, Jessy D Dorn2, Mark S Humayun3, Gislin Dagnelie4, James Handa4, Pierre-Olivier Barale5, José-Alain Sahel6, Paulo E Stanga7, Farhad Hafezi8, Avinoam B Safran9, Joel Salzmann10, Arturo Santos11, David Birch12, Rand Spencer13, Artur V Cideciyan14, Eugene de Juan15, Jacque L Duncan15, Dean Eliott16, Amani Fawzi17, Lisa C Olmos de Koo3, Allen C Ho18, Gary Brown18, Julia Haller19, Carl Regillo18, Lucian V Del Priore20, Aries Arditi21, Robert J Greenberg22. 1. Department of Vitreoretinal Surgery, Moorfields Eye Hospital, NHS Foundation Trust, NIHR Moorfields Biomedical Research Centre, London, United Kingdom and Department of Brain Science, University College London (UCL). 2. Second Sight Medical Products, Inc, Sylmar, California. Electronic address: jdorn@secondsight.com. 3. University of Southern California, Los Angeles, California. 4. Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland. 5. Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris, France. 6. Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris, France; Sorbonne Universities-UPMC Paris-6, and Institut de la Vision, Paris, France; Rothschild Ophthalmology Foundation, Paris, France. 7. Manchester Royal Eye Hospital, Manchester Vision Regeneration (MVR) Laboratory at NIHR/Wellcome Trust Manchester CRF, and Manchester Academic Health Science Centre and Centre for Ophthalmology and Vision Research, Institute of Human Development, University of Manchester, Manchester, United Kingdom. 8. University of Southern California, Los Angeles, California; ELZA Institute, Zurich, Switzerland; Hôpitaux Universitaires de Genève, Geneva, Switzerland. 9. Sorbonne Universities-UPMC Paris-6, and Institut de la Vision, Paris, France; Hôpitaux Universitaires de Genève, Geneva, Switzerland. 10. Hôpitaux Universitaires de Genève, Geneva, Switzerland. 11. Centro de Retina Medica y Quirúrgica, SC, and Tecnologico de Monterrey, Guadalajara, Mexico. 12. Retina Foundation of the Southwest, Dallas, Texas. 13. Texas Retina Associates, Dallas, Texas. 14. Scheie Eye Institute, University of Pennsylvania, Philadelphia, Pennsylvania. 15. University of California, San Francisco, San Francisco, California. 16. University of Southern California, Los Angeles, California; Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, Massachusetts. 17. University of Southern California, Los Angeles, California; Feinberg School of Medicine, Northwestern University, Chicago, Illinois. 18. Wills Eye Hospital, Philadelphia, Pennsylvania. 19. Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland; Wills Eye Hospital, Philadelphia, Pennsylvania. 20. Columbia University, New York, and Storm Eye Institute, Charleston, South Carolina. 21. Lighthouse Guild, New York, and Visibility Metrics, LLC, Chappaqua, New York. 22. Second Sight Medical Products, Inc, Sylmar, California.
Abstract
PURPOSE: The Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) was developed to restore some vision to patients blind as a result of retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception resulting from end-stage RP. DESIGN: Prospective, multicenter, single-arm clinical trial. Within-patient controls included the nonimplanted fellow eye and patients' native residual vision compared with their vision with the Argus II. PARTICIPANTS: Thirty participants in 10 centers in the United States and Europe. METHODS: The worse-seeing eye of blind patients was implanted with the Argus II. Patients 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. Secondary measures included functional vision performance on objectively scored real-world tasks. RESULTS: Twenty-four of 30 patients remained implanted with functioning Argus II Systems at 5 years after implantation. Only 1 additional serious adverse event was experienced after the 3-year time point. Patients performed significantly better with the Argus II on than off on all visual function tests and functional vision tasks. CONCLUSIONS: The 5-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind as a result of RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada.
PURPOSE: The Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) was developed to restore some vision to patients blind as a result of retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception resulting from end-stage RP. DESIGN: Prospective, multicenter, single-arm clinical trial. Within-patient controls included the nonimplanted fellow eye and patients' native residual vision compared with their vision with the Argus II. PARTICIPANTS: Thirty participants in 10 centers in the United States and Europe. METHODS: The worse-seeing eye of blind patients was implanted with the Argus II. Patients 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. Secondary measures included functional vision performance on objectively scored real-world tasks. RESULTS: Twenty-four of 30 patients remained implanted with functioning Argus II Systems at 5 years after implantation. Only 1 additional serious adverse event was experienced after the 3-year time point. Patients performed significantly better with the Argus II on than off on all visual function tests and functional vision tasks. CONCLUSIONS: The 5-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind as a result of RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada.
Authors: Mark S Humayun; Jessy D Dorn; Lyndon da Cruz; Gislin Dagnelie; José-Alain Sahel; Paulo E Stanga; Artur V Cideciyan; Jacque L Duncan; Dean Eliott; Eugene Filley; Allen C Ho; Arturo Santos; Avinoam B Safran; Aries Arditi; Lucian V Del Priore; Robert J Greenberg Journal: Ophthalmology Date: 2012-01-11 Impact factor: 12.079
Authors: Jessy D Dorn; Ashish K Ahuja; Avi Caspi; Lyndon da Cruz; Gislin Dagnelie; Jose-Alain Sahel; Robert J Greenberg; Matthew J McMahon Journal: JAMA Ophthalmol Date: 2013-02 Impact factor: 7.389
Authors: A K Ahuja; J D Dorn; A Caspi; M J McMahon; G Dagnelie; L Dacruz; P Stanga; M S Humayun; R J Greenberg Journal: Br J Ophthalmol Date: 2010-09-29 Impact factor: 4.638
Authors: Allen C Ho; Mark S Humayun; Jessy D Dorn; Lyndon da Cruz; Gislin Dagnelie; James Handa; Pierre-Olivier Barale; José-Alain Sahel; Paulo E Stanga; Farhad Hafezi; Avinoam B Safran; Joel Salzmann; Arturo Santos; David Birch; Rand Spencer; Artur V Cideciyan; Eugene de Juan; Jacque L Duncan; Dean Eliott; Amani Fawzi; Lisa C Olmos de Koo; Gary C Brown; Julia A Haller; Carl D Regillo; Lucian V Del Priore; Aries Arditi; Duane R Geruschat; Robert J Greenberg Journal: Ophthalmology Date: 2015-07-08 Impact factor: 12.079
Authors: Lauren N Ayton; Peter J Blamey; Robyn H Guymer; Chi D Luu; David A X Nayagam; Nicholas C Sinclair; Mohit N Shivdasani; Jonathan Yeoh; Mark F McCombe; Robert J Briggs; Nicholas L Opie; Joel Villalobos; Peter N Dimitrov; Mary Varsamidis; Matthew A Petoe; Chris D McCarthy; Janine G Walker; Nick Barnes; Anthony N Burkitt; Chris E Williams; Robert K Shepherd; Penelope J Allen Journal: PLoS One Date: 2014-12-18 Impact factor: 3.240
Authors: Duane R Geruschat; Thomas P Richards; Aries Arditi; Lyndon da Cruz; Gislin Dagnelie; Jessy D Dorn; Jacque L Duncan; Allen C Ho; Lisa C Olmos de Koo; José-Alain Sahel; Paulo E Stanga; Gabriele Thumann; Vizhong Wang; Robert J Greenberg Journal: Clin Exp Optom Date: 2016-01-24 Impact factor: 2.742
Authors: Ninel Z Gregori; Natalia F Callaway; Catherine Hoeppner; Alex Yuan; Aleksandra Rachitskaya; William Feuer; Hossein Ameri; J Fernando Arevalo; Albert J Augustin; David G Birch; Gislin Dagnelie; Salvatore Grisanti; Janet L Davis; Paul Hahn; James T Handa; Allen C Ho; Suber S Huang; Mark S Humayun; Raymond Iezzi; K Thiran Jayasundera; Gregg T Kokame; Byron L Lam; Jennifer I Lim; Naresh Mandava; Sandra R Montezuma; Lisa Olmos de Koo; Peter Szurman; Lejla Vajzovic; Peter Wiedemann; James Weiland; Jiong Yan; David N Zacks Journal: Am J Ophthalmol Date: 2018-06-27 Impact factor: 5.258
Authors: Young Jun Yoon; Jae-Ik Lee; Ye Ji Jang; Seungki An; Jae Hun Kim; Shelley I Fried; Maesoon Im Journal: IEEE Trans Neural Syst Rehabil Eng Date: 2020-06-18 Impact factor: 3.802