June 2015
Volume 56, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2015
Five-year data from the Argus II Retinal Prosthesis System Clinical Tria
Author Affiliations & Notes
  • Robert Jay Greenberg
    Second Sight Medical Products, Inc, Sylmar, CA
  • Mark S Humayun
    University of Southern California, Los Angeles, CA
  • Lyndon da Cruz
    Moorfields Eye Hospital, London, United Kingdom
    NIHR Biomedical Research Centre for Ophthalmology, London, United Kingdom
  • Gislin Dagnelie
    Lions Vision Research and Rehab Center, Johns Hopkins University, Baltimore, MD
  • Paulo E Stanga
    Manchester Royal Eye Hospital, Manchester, United Kingdom
    Manchester Vision Regeneration Lab at NIHR/Wellcome Trust Manchester, Manchester, United Kingdom
  • Allen C Ho
    Wills Eye Hospital, Philadelphia, CA
  • David G Birch
    Retina Foundation of the Southwest, Dallas, TX
  • Jacque L Duncan
    University of California San Francisco, San Francisco, CA
  • José Sahel
    Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris, France
  • Footnotes
    Commercial Relationships Robert Greenberg, Second Sight Medical Products, Inc. (E), Second Sight Medical Products, Inc. (I), Second Sight Medical Products, Inc. (P); Mark Humayun, Second Sight Medical Products, Inc. (C), Second Sight Medical Products, Inc. (I); Lyndon da Cruz, None; Gislin Dagnelie, None; Paulo Stanga, None; Allen Ho, None; David Birch, None; Jacque Duncan, None; José Sahel, Pixium Vision (I)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2015, Vol.56, 754. doi:
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    • Get Citation

      Robert Jay Greenberg, Mark S Humayun, Lyndon da Cruz, Gislin Dagnelie, Paulo E Stanga, Allen C Ho, David G Birch, Jacque L Duncan, José Sahel, ; Five-year data from the Argus II Retinal Prosthesis System Clinical Tria. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):754.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: To present five-year results from the Argus II Retinal Prosthesis Study (clinicaltrials.gov NCT00407602) and update on the commercial implant program.

Methods: All subjects implanted with a Second Sight Argus II implant were blind from retinitis pigmentosa or similar disorders. In the clinical trial, visual function was evaluated by visual function tests such as Square Localization, Direction of Motion, and Grating Visual Acuity. Assessments of functional vision included controlled Orientation and Mobility (O&M) tasks, and the Functional Low-Vision Observer Rated Assessment (FLORA).

Results: As of October 15, 2014, 30 subjects have been implanted at 10 centers in the clinical trial. Subjects (excluding three who have been explanted) have been implanted an average of 6.2 ± 0.9 years (range of 5.2 - 7.4). The Argus II remains implanted and functioning in 24 subjects. The safety profile remains acceptable. Performance has remained better with the System ON than OFF on all visual tests, with these results sustained out beyond 5 years of chronic use.<br /> As of October 15, 2014, there have been 54 additional implants of the Argus II commercially in Europe, the U.S., Canada, and the Middle East.

Conclusions: With 176 cumulative subject-years of clinical trial follow-up on 30 clinical trial subjects, this is the largest study of a visual prosthesis to date. The results confirm previous reports on the ability of the Argus II prosthesis to provide visual function and functional vision over several years of chronic device use. Current research efforts are directed toward a feasibility study for age-related macular degeneration, and the development of a prosthesis for the primary visual cortex.

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