Journal
OPHTHALMOLOGY
Volume 123, Issue 10, Pages 2248-2254Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.ophtha.2016.06.049
Keywords
-
Categories
Funding
- National Institutes of Health, Bethesda, Maryland [5R01EY012893, 07, 1RC3EY020778]
- Second Sight Medical Products, Inc., Sylmar, California
Ask authors/readers for more resources
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 non-implanted 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. (C) 2016 by the American Academy of Ophthalmology.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available