TY - JOUR
T1 - Interim results from the international trial of second sight's visual prosthesis
AU - Humayun, Mark S.
AU - Dorn, Jessy D.
AU - Da Cruz, Lyndon
AU - Dagnelie, Gislin
AU - Sahel, José Alain
AU - Stanga, Paulo E.
AU - Cideciyan, Artur V.
AU - Duncan, Jacque L.
AU - Eliott, Dean
AU - Filley, Eugene
AU - Ho, Allen C.
AU - Santos, Arturo
AU - Safran, Avinoam B.
AU - Arditi, Aries
AU - Del Priore, Lucian V.
AU - Greenberg, Robert J.
N1 - Funding Information:
Supported by the National Institutes of Health , Bethesda, Maryland (grant no.: 5R01EY012893-10 [RJG]). Sponsored by Second Sight Medical Products, Inc., Sylmar, California. The sponsor participated in the design of the study, conducting the study, data collection, data management, data analysis, interpretation of the data, preparation, and review of the manuscript.
PY - 2012/4
Y1 - 2012/4
N2 - 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 performance end points were assessments of visual function as well as performance on orientation and mobility tasks. Results: Subjects performed statistically better with the system on versus off in the following tasks: object localization (96% of subjects), motion discrimination (57%), and discrimination of oriented gratings (23%). The best recorded visual acuity to date is 20/1260. Subjects' mean performance on orientation and mobility tasks was significantly better when the system was on versus off. Seventy percent of the patients did not have any serious adverse events (SAEs). The most common SAE reported was either conjunctival erosion or dehiscence over the extraocular implant and was treated successfully in all subjects except in one, who required explantation of the device without further complications. Conclusions: The long-term safety results of Second Sight's retinal prosthesis system are acceptable, and most subjects with profound visual loss perform better on visual tasks with system than without it. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.
AB - 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 performance end points were assessments of visual function as well as performance on orientation and mobility tasks. Results: Subjects performed statistically better with the system on versus off in the following tasks: object localization (96% of subjects), motion discrimination (57%), and discrimination of oriented gratings (23%). The best recorded visual acuity to date is 20/1260. Subjects' mean performance on orientation and mobility tasks was significantly better when the system was on versus off. Seventy percent of the patients did not have any serious adverse events (SAEs). The most common SAE reported was either conjunctival erosion or dehiscence over the extraocular implant and was treated successfully in all subjects except in one, who required explantation of the device without further complications. Conclusions: The long-term safety results of Second Sight's retinal prosthesis system are acceptable, and most subjects with profound visual loss perform better on visual tasks with system than without it. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.
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U2 - 10.1016/j.ophtha.2011.09.028
DO - 10.1016/j.ophtha.2011.09.028
M3 - Article
C2 - 22244176
AN - SCOPUS:84859269427
SN - 0161-6420
VL - 119
SP - 779
EP - 788
JO - Ophthalmology
JF - Ophthalmology
IS - 4
ER -