Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind

Allen C. Ho, Mark S. Humayun, Jessy D. Dorn, Lyndon Da Cruz, Gislin Dagnelie, James Handa, Pierre Olivier Barale, José Alain Sahel, Paulo E. Stanga, Farhad Hafezi, Avinoam B. Safran, Joel Salzmann, Arturo Santos, David Birch, Rand Spencer, Artur V. Cideciyan, Eugene De Juan, Jacque L. Duncan, Dean Eliott, Amani FawziLisa C. Olmos De Koo, Gary C. Brown, Julia A. Haller, Carl D. Regillo, Lucian V. Del Priore, Aries Arditi, Duane R. Geruschat, Robert J. Greenberg

Research output: Contribution to journalArticle

Abstract

Purpose Retinitis pigmentosa (RP) is a group of inherited retinal degenerations leading to blindness due to photoreceptor loss. Retinitis pigmentosa is a rare disease, affecting only approximately 100 000 people in the United States. There is no cure and no approved medical therapy to slow or reverse RP. The purpose of this clinical trial was to evaluate the safety, reliability, and benefit of the Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) in restoring some visual function to subjects completely blind from RP. We report clinical trial results at 1 and 3 years after implantation. Design The study is a multicenter, single-arm, prospective clinical trial. Participants There were 30 subjects in 10 centers in the United States and Europe. Subjects served as their own controls, that is, implanted eye versus fellow eye, and system on versus system off (native residual vision). Methods The Argus II System was implanted on and in a single eye (typically the worse-seeing eye) of blind subjects. Subjects 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. Results A total of 29 of 30 subjects had functioning Argus II Systems implants 3 years after implantation. Eleven subjects experienced a total of 23 serious device- or surgery-related adverse events. All were treated with standard ophthalmic care. As a group, subjects performed significantly better with the system on than off on all visual function tests and functional vision assessments. Conclusions The 3-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind from RP. Earlier results from this trial were used to gain approval of the Argus II by the Food and Drug Administration and a CE mark in Europe. The Argus II System is the first and only retinal implant to have both approvals.

Original languageEnglish (US)
Pages (from-to)1547-1554
Number of pages8
JournalOphthalmology
Volume122
Issue number8
DOIs
StatePublished - Aug 1 2015

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Retinitis Pigmentosa
Prostheses and Implants
Clinical Trials
Safety
Visual Prosthesis
Vision Tests
Outcome Assessment (Health Care)
Retinal Degeneration
United States Food and Drug Administration
Blindness
Rare Diseases
Glass
Retina
Electrodes
Equipment and Supplies

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind. / Ho, Allen C.; Humayun, Mark S.; Dorn, Jessy D.; Da Cruz, Lyndon; Dagnelie, Gislin; Handa, James; Barale, Pierre Olivier; Sahel, José Alain; Stanga, Paulo E.; Hafezi, Farhad; Safran, Avinoam B.; Salzmann, Joel; Santos, Arturo; Birch, David; Spencer, Rand; Cideciyan, Artur V.; De Juan, Eugene; Duncan, Jacque L.; Eliott, Dean; Fawzi, Amani; Olmos De Koo, Lisa C.; Brown, Gary C.; Haller, Julia A.; Regillo, Carl D.; Del Priore, Lucian V.; Arditi, Aries; Geruschat, Duane R.; Greenberg, Robert J.

In: Ophthalmology, Vol. 122, No. 8, 01.08.2015, p. 1547-1554.

Research output: Contribution to journalArticle

Ho, AC, Humayun, MS, Dorn, JD, Da Cruz, L, Dagnelie, G, Handa, J, Barale, PO, Sahel, JA, Stanga, PE, Hafezi, F, Safran, AB, Salzmann, J, Santos, A, Birch, D, Spencer, R, Cideciyan, AV, De Juan, E, Duncan, JL, Eliott, D, Fawzi, A, Olmos De Koo, LC, Brown, GC, Haller, JA, Regillo, CD, Del Priore, LV, Arditi, A, Geruschat, DR & Greenberg, RJ 2015, 'Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind', Ophthalmology, vol. 122, no. 8, pp. 1547-1554. https://doi.org/10.1016/j.ophtha.2015.04.032
Ho, Allen C. ; Humayun, Mark S. ; Dorn, Jessy D. ; Da Cruz, Lyndon ; Dagnelie, Gislin ; Handa, James ; Barale, Pierre Olivier ; Sahel, José Alain ; Stanga, Paulo E. ; Hafezi, Farhad ; Safran, Avinoam B. ; Salzmann, Joel ; Santos, Arturo ; Birch, David ; Spencer, Rand ; Cideciyan, Artur V. ; De Juan, Eugene ; Duncan, Jacque L. ; Eliott, Dean ; Fawzi, Amani ; Olmos De Koo, Lisa C. ; Brown, Gary C. ; Haller, Julia A. ; Regillo, Carl D. ; Del Priore, Lucian V. ; Arditi, Aries ; Geruschat, Duane R. ; Greenberg, Robert J. / Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind. In: Ophthalmology. 2015 ; Vol. 122, No. 8. pp. 1547-1554.
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T1 - Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind

AU - Ho, Allen C.

AU - Humayun, Mark S.

AU - Dorn, Jessy D.

AU - Da Cruz, Lyndon

AU - Dagnelie, Gislin

AU - Handa, James

AU - Barale, Pierre Olivier

AU - Sahel, José Alain

AU - Stanga, Paulo E.

AU - Hafezi, Farhad

AU - Safran, Avinoam B.

AU - Salzmann, Joel

AU - Santos, Arturo

AU - Birch, David

AU - Spencer, Rand

AU - Cideciyan, Artur V.

AU - De Juan, Eugene

AU - Duncan, Jacque L.

AU - Eliott, Dean

AU - Fawzi, Amani

AU - Olmos De Koo, Lisa C.

AU - Brown, Gary C.

AU - Haller, Julia A.

AU - Regillo, Carl D.

AU - Del Priore, Lucian V.

AU - Arditi, Aries

AU - Geruschat, Duane R.

AU - Greenberg, Robert J.

PY - 2015/8/1

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N2 - Purpose Retinitis pigmentosa (RP) is a group of inherited retinal degenerations leading to blindness due to photoreceptor loss. Retinitis pigmentosa is a rare disease, affecting only approximately 100 000 people in the United States. There is no cure and no approved medical therapy to slow or reverse RP. The purpose of this clinical trial was to evaluate the safety, reliability, and benefit of the Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) in restoring some visual function to subjects completely blind from RP. We report clinical trial results at 1 and 3 years after implantation. Design The study is a multicenter, single-arm, prospective clinical trial. Participants There were 30 subjects in 10 centers in the United States and Europe. Subjects served as their own controls, that is, implanted eye versus fellow eye, and system on versus system off (native residual vision). Methods The Argus II System was implanted on and in a single eye (typically the worse-seeing eye) of blind subjects. Subjects 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. Results A total of 29 of 30 subjects had functioning Argus II Systems implants 3 years after implantation. Eleven subjects experienced a total of 23 serious device- or surgery-related adverse events. All were treated with standard ophthalmic care. As a group, subjects performed significantly better with the system on than off on all visual function tests and functional vision assessments. Conclusions The 3-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind from RP. Earlier results from this trial were used to gain approval of the Argus II by the Food and Drug Administration and a CE mark in Europe. The Argus II System is the first and only retinal implant to have both approvals.

AB - Purpose Retinitis pigmentosa (RP) is a group of inherited retinal degenerations leading to blindness due to photoreceptor loss. Retinitis pigmentosa is a rare disease, affecting only approximately 100 000 people in the United States. There is no cure and no approved medical therapy to slow or reverse RP. The purpose of this clinical trial was to evaluate the safety, reliability, and benefit of the Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) in restoring some visual function to subjects completely blind from RP. We report clinical trial results at 1 and 3 years after implantation. Design The study is a multicenter, single-arm, prospective clinical trial. Participants There were 30 subjects in 10 centers in the United States and Europe. Subjects served as their own controls, that is, implanted eye versus fellow eye, and system on versus system off (native residual vision). Methods The Argus II System was implanted on and in a single eye (typically the worse-seeing eye) of blind subjects. Subjects 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. Results A total of 29 of 30 subjects had functioning Argus II Systems implants 3 years after implantation. Eleven subjects experienced a total of 23 serious device- or surgery-related adverse events. All were treated with standard ophthalmic care. As a group, subjects performed significantly better with the system on than off on all visual function tests and functional vision assessments. Conclusions The 3-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind from RP. Earlier results from this trial were used to gain approval of the Argus II by the Food and Drug Administration and a CE mark in Europe. The Argus II System is the first and only retinal implant to have both approvals.

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