作者
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, Argus II Study Group
发表日期
2012/4/1
期刊
Ophthalmology
卷号
119
期号
4
页码范围
779-788
出版商
Elsevier
简介
PURPOSE
This study evaluated the Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc., Sylmar, CA) in blind subjects with severe outer retinal degeneration.
DESIGN
Single-arm, prospective, multicenter clinical trial.
PARTICIPANTS
Thirty subjects were enrolled in the United States and Europe between June 6, 2007, and August 11, 2009. All subjects were followed up for a minimum of 6 months and up to 2.7 years.
METHODS
The electronic stimulator and antenna of the implant were sutured onto the sclera using an encircling silicone band. Next, a pars plana vitrectomy was performed, and the electrode array and cable were introduced into the eye via a pars plana sclerotomy. The microelectrode array then was tacked to the epiretinal surface.
MAIN OUTCOME MEASURES
The primary safety end points for the trial were the number, severity, and relation of adverse events. Principal …
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MS Humayun, JD Dorn, L Da Cruz, G Dagnelie… - Ophthalmology, 2012