@article {836796,
	title = {Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial.},
	journal = {Ophthalmology},
	volume = {123},
	number = {10},
	year = {2016},
	month = {2016 Oct},
	pages = {2248-54},
	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{\textquoteright} 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.},
	issn = {1549-4713},
	doi = {10.1016/j.ophtha.2016.06.049},
	author = {da Cruz, Lyndon and Dorn, Jessy D and Humayun, Mark S and Dagnelie, Gislin and Handa, James and Barale, Pierre-Olivier and Sahel, Jos{\'e}-Alain and Stanga, Paulo E and Hafezi, Farhad and Safran, Avinoam B and Salzmann, Joel and Santos, Arturo and Birch, David and Spencer, Rand and Cideciyan, Artur V and de Juan, Eugene and Duncan, Jacque L and Eliott, Dean and Fawzi, Amani and Olmos de Koo, Lisa C and Ho, Allen C and Brown, Gary and Haller, Julia and Regillo, Carl and Del Priore, Lucian V and Arditi, Aries and Greenberg, Robert J and Argus II Study Group}
}
