April 2014
Volume 55, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2014
An Update on the Argus II Epiretinal Implant
Author Affiliations & Notes
  • Mark S Humayun
    Ophthalmology, Doheny Eye Institute - USC, Los Angeles, CA
  • Lyndon Da Cruz
    NIHR Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital, London, United Kingdom
  • Gislin Dagnelie
    Lions Vision Research and Rehabilitation Center, Johns Hopkins University, Baltimore, CA
  • Paulo E Stanga
    4Manchester Royal Eye Hospital, Manchester, United Kingdom
  • Allen C Ho
    Wills Eye Institute, Philadelphia, PA
  • Robert Jay Greenberg
    Second Sight Medical Products, Inc., Sylmar, CA
  • David G Birch
    Retina Foundation of the Southwest, Dallas, TX
  • Jacque L Duncan
    University of California, San Francisco, CA
  • Jose-Alain Sahel
    Center Hospitalier National d’Ophtalmologie des Quinze-Vingts, Paris, France
  • Footnotes
    Commercial Relationships Mark Humayun, Alcon (C), Alcon (R), Bausch & Lomb (C), Bausch & Lomb (F), Bausch & Lomb (P), Bausch & Lomb (R), Bausch & Lomb (S), Iridex (P), Iridex (R), Regenerative Patch Technologies (I), Replenish (C), Replenish (I), Replenish (R), Replenish (S), Second Sight (C), Second Sight (F), Second Sight (I), Second Sight (P), Second Sight (R), Second Sight (S); Lyndon Da Cruz, None; Gislin Dagnelie, None; Paulo Stanga, OPTOS PLC (C), OPTOS PLC (F), OPTOS PLC (R), TOPCON CORP (C), TOPCON CORP (F), TOPCON CORP (R); Allen Ho, None; Robert Greenberg, Second Sight Medical Products, Inc (E), Second Sight Medical Products, Inc (I), Second Sight Medical Products, Inc (P), Second Sight Medical Products, Inc (S); David Birch, Acucela:Code (C), Neurotech, USA (C), QLT (C); Jacque Duncan, None; Jose-Alain Sahel, UPMC/Essilor (P)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science April 2014, Vol.55, 5968. doi:
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    • Get Citation

      Mark S Humayun, Lyndon Da Cruz, Gislin Dagnelie, Paulo E Stanga, Allen C Ho, Robert Jay Greenberg, David G Birch, Jacque L Duncan, Jose-Alain Sahel, ; An Update on the Argus II Epiretinal Implant. Invest. Ophthalmol. Vis. Sci. 2014;55(13):5968.

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

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Abstract

Purpose: To present updated results from the Argus II Retinal Prosthesis Study (clinicaltrials.gov NCT00407602) and new results from post market/commercial patients

Methods: All subjects implanted with a Second Sight Argus II implant had severe outer retinal degenerations. In the clinical trial, visual function was evaluated by visual function tests presented on an LCD screen, including 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 September 30, 2013, 30 subjects have been implanted at 10 centers in the clinical trial. Subjects (excluding one who was explanted at 1.2 years) have been implanted an average of 4.9 ± 0.6 years (range of 4.2 - 6.3). The Argus II remains implanted and functioning in 26 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. As of September 30, 2013, 30 additional patients have been implanted with the Argus II in the post-market setting in Europe. In the first year, only two subjects experienced a serious adverse event (12.5%), compared to 36.7% at 1-year post-op in the clinical trial. Surgical time was reduced in the commercial patients compared to the clinical trial subjects.

Conclusions: With 150 cumulative patient-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. The Argus II Retinal Prosthesis System is commercially available in the US and Europe, and in the post-market setting has shown improved safety and required shorter surgical implantation time.

Keywords: 688 retina • 698 retinal development • 462 clinical (human) or epidemiologic studies: outcomes/complications  
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