Interim results from the international trial of second sight's visual prosthesis

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

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)779-788
Number of pages10
JournalOphthalmology
Volume119
Issue number4
DOIs
StatePublished - Apr 2012

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Visual Prosthesis
Temazepam
Disclosure
Safety
Retinal Degeneration
Sclera
Vitrectomy
Microelectrodes
Silicones
Visual Acuity
Multicenter Studies
Electrodes
Outcome Assessment (Health Care)
Clinical Trials
Equipment and Supplies
Discrimination (Psychology)

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Humayun, M. S., Dorn, J. D., Da Cruz, L., Dagnelie, G., Sahel, J. A., Stanga, P. E., ... Greenberg, R. J. (2012). Interim results from the international trial of second sight's visual prosthesis. Ophthalmology, 119(4), 779-788. https://doi.org/10.1016/j.ophtha.2011.09.028

Interim results from the international trial of second sight's visual prosthesis. / Humayun, Mark S.; Dorn, Jessy D.; Da Cruz, Lyndon; Dagnelie, Gislin; Sahel, José Alain; Stanga, Paulo E.; Cideciyan, Artur V.; Duncan, Jacque L.; Eliott, Dean; Filley, Eugene; Ho, Allen C.; Santos, Arturo; Safran, Avinoam B.; Arditi, Aries; Del Priore, Lucian V.; Greenberg, Robert J.

In: Ophthalmology, Vol. 119, No. 4, 04.2012, p. 779-788.

Research output: Contribution to journalArticle

Humayun, MS, Dorn, JD, Da Cruz, L, Dagnelie, G, Sahel, JA, Stanga, PE, Cideciyan, AV, Duncan, JL, Eliott, D, Filley, E, Ho, AC, Santos, A, Safran, AB, Arditi, A, Del Priore, LV & Greenberg, RJ 2012, 'Interim results from the international trial of second sight's visual prosthesis', Ophthalmology, vol. 119, no. 4, pp. 779-788. https://doi.org/10.1016/j.ophtha.2011.09.028
Humayun, Mark S. ; Dorn, Jessy D. ; Da Cruz, Lyndon ; Dagnelie, Gislin ; Sahel, José Alain ; Stanga, Paulo E. ; Cideciyan, Artur V. ; Duncan, Jacque L. ; Eliott, Dean ; Filley, Eugene ; Ho, Allen C. ; Santos, Arturo ; Safran, Avinoam B. ; Arditi, Aries ; Del Priore, Lucian V. ; Greenberg, Robert J. / Interim results from the international trial of second sight's visual prosthesis. In: Ophthalmology. 2012 ; Vol. 119, No. 4. pp. 779-788.
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AU - Dorn, Jessy D.

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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.

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