%0 Journal Article %J Ophthalmology %D 2016 %T Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial. %A da Cruz, Lyndon %A Dorn, Jessy D %A Humayun, Mark S %A Dagnelie, Gislin %A Handa, James %A Barale, Pierre-Olivier %A Sahel, José-Alain %A Stanga, Paulo E %A Hafezi, Farhad %A Safran, Avinoam B %A Salzmann, Joel %A Santos, Arturo %A Birch, David %A Spencer, Rand %A Cideciyan, Artur V %A de Juan, Eugene %A Duncan, Jacque L %A Eliott, Dean %A Fawzi, Amani %A Olmos de Koo, Lisa C %A Ho, Allen C %A Brown, Gary %A Haller, Julia %A Regillo, Carl %A Del Priore, Lucian V %A Arditi, Aries %A Greenberg, Robert J %A Argus II Study Group %X

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.

%B Ophthalmology %V 123 %P 2248-54 %8 2016 Oct %G ENG %N 10 %1 http://www.ncbi.nlm.nih.gov/pubmed/27453256?dopt=Abstract %R 10.1016/j.ophtha.2016.06.049