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Five-year safety and performance results from the argus II retinal prosthesis system clinical trial.
Open accessAbstract
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 nonimplanted 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.
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In the citing paper
“At present, retinal prostheses are the most successful approach in this field, and several retinal devices have already been approved for patients with retinal dystrophies (Da Cruz et al., 2016; Stingl et al., 2017).”
From Toward Long-Term Communication With the Brain in the Blind by Intracortical Stimulation: Challenges and Future Prospects (2020) · cites this paper as Da Cruz et al., 2016
In the citing paper
“At present, retinal prostheses are the most successful approach in this field, and several retinal devices have already been approved for patients with retinal dystrophies (Da Cruz et al., 2016; Stingl et al., 2017).”
From Toward Long-Term Communication With the Brain in the Blind by Intracortical Stimulation: Challenges and Future Prospects (2020) · cites this paper as Da Cruz et al., 2016
In the citing paper
“several research groups are focusing their efforts on the development of new approaches for artificial vision based on electric stimulation of the retina”
From Toward Long-Term Communication With the Brain in the Blind by Intracortical Stimulation: Challenges and Future Prospects (2020) · cites this paper as Da Cruz et al., 2016
In the citing paper
“A multicentre clinical trial of Argus II in patients with end-stage retinitis pigmentosa showed that the device enables basic visual tasks, such as grating visual acuity, high contrast object localisation and detection of direction of motion.”
From Correcting visual loss by genetics and prosthetics (2020) · cites this paper as da Cruz 2016
In the citing paper
“The durability of the device generally exceeded 5 years and the best reported grating visual acuity is around 1.8 logMAR equivalent (6/379 Snellen) [da Cruz 2016; Schaffrath 2019].”
From Correcting visual loss by genetics and prosthetics (2020) · cites this paper as da Cruz 2016
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Interim results from the international trial of Second Sight's visual prosthesis
Humayun, M. S., Dorn, J. D., da Cruz, L., Dagnelie, G., Sahel, J.-A., Stanga, P. E., Cideciyan, A. V., Duncan, J. L., Eliott, D., Filley, E., et al. (2012) · Ophthalmology · doi:10.1016/j.ophtha.2011.09.028 · Cited by 700
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Ahuja, A. K., Dorn, J. D., Caspi, A., McMahon, M. J., Dagnelie, G., daCruz, L., Stanga, P., Humayun, M. S., Greenberg, R. J., & Argus II Study Group (2011) · British Journal of Ophthalmology · doi:10.1136/bjo.2010.179622 · Cited by 289
Self-citationLong-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind
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Self-citationDorn, J. D., Ahuja, A. K., Caspi, A., da Cruz, L., Dagnelie, G., Sahel, J.-A., Greenberg, R. J., McMahon, M. J., & Argus II Study Group, F. T. (2013) · JAMA Ophthalmology · doi:10.1001/2013.jamaophthalmol.221 · Cited by 177
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Self-citationSafety evaluation of “retina implant alpha IMS”—a prospective clinical trial
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Metadata
- Authors
- da Cruz, L., Dorn, J. D., Humayun, M. S., Dagnelie, G., Handa, J., Barale, P.-O., Sahel, J.-A., Stanga, P. E., Hafezi, F., Safran, A. B., Salzmann, J., Santos, A., Birch, D., Spencer, R., Cideciyan, A. V., de Juan, E., Duncan, J. L., Eliott, D., Fawzi, A., Olmos de Koo, L. C., Ho, A. C., Brown, G., Haller, J., Regillo, C., Del Priore, L. V., Arditi, A., & Greenberg, R. J.
- Affiliations
- Second Sight Medical Products (US)
- University of Southern California (US)
- Johns Hopkins University (US)
- Centre hospitalier national d'ophtalmologie des Quinze-Vingts (FR)
- Institut de la Vision (FR)
- Manchester Academic Health Science Centre (GB)
- Centro de Retina Médica y Quirúrgica (MX)
- Retina Foundation of the Southwest (US)
- Texas Retina Associates (United States) (US)
- University of Pennsylvania (US)
- University of California, San Francisco (US)
- Northwestern University (US)
- Wills Eye Hospital (US)
- Lighthouse Guild (US)
- Corresponding author
- Dorn, Jessy D.
- ORCID
- Venue
- Ophthalmology
- Publisher
- Elsevier BV
- Published
- 2016-10
- Volume
- 123
- Issue
- 10
- Pages
- 2248-2254
- ISSN
- 0161-6420 (ISSN-L)
- PMC
- PMC5035591
- OpenAlex
- W2476154117
- Cited by
- 359
- References
- 12
- Citations by year
- 2026: 30 · 2025: 23 · 2024: 20 · 2023: 33 · 2022: 33 · 2021: 45 · 2020: 47 · 2019: 48 · 2018: 41 · 2017: 35 · 2016: 3
- FWCI
- 23.74
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Ophthalmology (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Archive ouverte UNIGE (University of Geneva) (publishedVersion, other-oa)
- PubMed Central (acceptedVersion)
- Institutional Repository of Tecnológico de Monterrey (Tecnológico de Monterrey) (submittedVersion, other-oa)
- UCL Discovery (University College London) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by-nc-nd)
- Archive ouverte UNIGE (University of Geneva) (submittedVersion, other-oa)
- Funders
- National Eye Institute (R01EY012893, RC3EY020778)
- Topics
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neuroscience and Neural Engineering
- Health Sciences › Medicine › Ophthalmology › Retinal Development and Disorders
- Health Sciences › Health Professions › Occupational Therapy › Assistive Technology in Communication and Mobility
- Keywords
- Argus II, retinal prosthesis, retinitis pigmentosa, outer retinal degeneration, long-term safety, visual function, functional vision, electrode arrays, blind patients, adverse events
- MeSH terms
- Adult, Aged, Blindness, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prospective Studies, Prosthesis Design, Retina, Retinitis Pigmentosa, Time Factors, Visual Acuity, Treatment Outcome, Persons with Visual Disabilities, Visual Prosthesis
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