Interim results from the international trial of Second Sight's visual prosthesis
Open accessAbstract
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.
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Epiretinal implants electrically activate retinal ganglion cells (RGCs) that have survived degeneration, causing them to send artificial visual signals to the brain.
“Epiretinal implants electrically activate retinal ganglion cells (RGCs) that have survived degeneration, causing them to send artificial visual signals to the brain.”
From Precise control of neural activity using dynamically optimized electrical stimulation (2024) · cites this paper as Humayun et al., 2012
Visual neuroprostheses have been implanted in the retina, optic nerve, and visual cortex of human subjects.
“To date, visual neuroprostheses have been implanted in the retina (Humayun et al. 2012; Stingl et al. 2013; Fujikado et al. 2016; Petoe et al. 2021; Barnes et al. 2016; Palanker et al. 2022; Xu et al. 2021), optic nerve (Veraart et al. 2003), and visual cortex of human subjects (Beauchamp et al. 2020; Fernández et al. 2021).”
From Sequential epiretinal stimulation improves discrimination in simple shape discrimination tasks only (2022) · cites this paper as Humayun et al. 2012
The highest visual acuity achieved with the Argus II is only about 20/1260, which is dictated by the 550 μm electrode spacing.
“Moreover, the highest level of visual acuity achieved is only about 20/1260 (Humayun et al. 2012), which is dictated by the 550 μm electrode spacing.”
From Sequential epiretinal stimulation improves discrimination in simple shape discrimination tasks only (2022) · cites this paper as Humayun et al. 2012
People with blindness using an Argus device improved on orientation and mobility tasks involving walking toward a high-contrast target and along a high-contrast line on the floor.
“When receiving visual input from an Argus device, people with blindness improved on orientation and mobility tasks based on walking towards a high-contrast target and walking along a high-contrast line on the floor (Humayun et al. 2012).”
From Sequential epiretinal stimulation improves discrimination in simple shape discrimination tasks only (2022) · cites this paper as Humayun et al. 2012
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- Authors
- 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., Ho, A. C., Santos, A., Safran, A. B., Arditi, A., Del Priore, L. V., & Greenberg, R. J.
- Affiliations
- University of Southern California (US)
- Second Sight Medical Products (US)
- Johns Hopkins University (US)
- Centre hospitalier national d'ophtalmologie des Quinze-Vingts (FR)
- Manchester Royal Eye Hospital (GB)
- University of Pennsylvania (US)
- University of California, San Francisco (US)
- Massachusetts Eye and Ear Infirmary (US)
- Retina Foundation of the Southwest (US)
- Wills Eye Hospital (US)
- Centro de Retina Médica y Quirúrgica (MX)
- University Hospital of Geneva (CH)
- Lighthouse Guild (US)
- Corresponding author
- Humayun, Mark S.
- ORCID
- Venue
- Ophthalmology
- Publisher
- Elsevier BV
- Published
- 2012-04
- Volume
- 119
- Issue
- 4
- Pages
- 779-788
- ISSN
- 0161-6420 (ISSN-L)
- PMC
- PMC3319859
- OpenAlex
- W2085039801
- Cited by
- 700
- References
- 30
- Citations by year
- 2026: 30 · 2025: 24 · 2024: 32 · 2023: 29 · 2022: 38 · 2021: 34 · 2020: 49 · 2019: 47 · 2018: 51 · 2017: 66 · 2016: 76 · 2015: 78 · 2014: 72 · 2013: 52 · 2012: 19
- FWCI
- 29.13
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Ophthalmology (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Funders
- National Institutes of Health (5R01EY012893-10)
- Topics
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neuroscience and Neural Engineering
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Retinal Development and Disorders
- Life Sciences › Neuroscience › Cognitive Neuroscience › Tactile and Sensory Interactions
- Keywords
- Argus II retinal prosthesis, retinal prosthesis, retinitis pigmentosa, outer retinal degeneration, visual function, orientation and mobility, device safety, adverse events, conjunctival erosion, pars plana vitrectomy, microelectrode arrays
- MeSH terms
- Adult, Aged, Blindness, Electrodes, Implanted, Electric Stimulation Therapy, Feasibility Studies, Female, Follow-Up Studies, Humans, Male, Microelectrodes, Middle Aged, Prospective Studies, Retina, Retinal Degeneration, Sclera, Sclerostomy, Sensory Thresholds, Visual Acuity, Visual Perception, Vitrectomy, Tomography, Optical Coherence, Visual Prosthesis
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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