Trial reportOphthalmology2012
Interim results from the international trial of Second Sight's visual prosthesis.
Trial report in Ophthalmology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 279 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Argus® II Retinal Stimulation System Feasibility Protocol
Observational Study of the Argus® II Retinal Prosthesis System
Who cites it
279 citing papers in PubMed, 2 syntheses or guidelines pooled it, 691 citations in OpenAlex.
- ISCEV and IPS guideline for the full-field stimulus test (FST).Documenta ophthalmologica. Advances in ophthalmology · 2024Guideline
- A systematic review of extended reality (XR) for understanding and augmenting vision loss.Journal of vision · 2023Pooled it
- Second-Generation (44-Channel) Suprachoroidal Retinal Prosthesis: Surgical Stability and Safety During a 2-Year Clinical Trial.Clinical & experimental ophthalmology · 2025Trial
- A Second-Generation (44-Channel) Suprachoroidal Retinal Prosthesis: Interim Clinical Trial Results.Translational vision science & technology · 2021Trial
- Photovoltaic Restoration of Central Vision in Atrophic Age-Related Macular Degeneration.Ophthalmology · 2020Trial
- Assessment of the Electronic Retinal Implant Alpha AMS in Restoring Vision to Blind Patients with End-Stage Retinitis Pigmentosa.Ophthalmology · 2018Trial
- Performance of real-world functional vision tasks by blind subjects improves after implantation with the Argus® II retinal prosthesis system.Clinical & experimental ophthalmology · 2017Trial
- Transfer characteristics of subretinal visual implants: corneally recorded implant responses.Documenta ophthalmologica. Advances in ophthalmology · 2016Trial
- Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial.Ophthalmology · 2016Trial
- An analysis of observer-rated functional vision in patients implanted with the Argus II Retinal Prosthesis System at three years.Clinical & experimental optometry · 2016Trial
- Generalizable neural decoding for clinically scalable brain-computer interfaces.npj biomedical innovations · 2026Review
- Restorative and regenerative therapies for vision loss.Eye (London, England) · 2026Review
- Extraocular Electrical Stimulation Activates Retinal Ganglion Cells In Vivo.bioRxiv : the preprint server for biology · 2026Article
- Intelligent Visual Prioritization for Retinal Prostheses via Context-Aware Object Ranking and Depth-Aware Phosphene Generation.Biomimetics (Basel, Switzerland) · 2026Article
- Seeing anew: Mechanisms, outcomes, and challenges in adapting to restored sight via visual prostheses.Progress in retinal and eye research · 2026Review
- Determinants of spatial resolution in retinal prostheses: understanding the gap between geometry and vision.Biomedical engineering letters · 2026Review
- Shared-Scale Predictive Benchmarking of an Acoustic-Radiation-Force Model for Frequency-Dependent Retinal Ganglion Cell Responses.Bioengineering (Basel, Switzerland) · 2026Article
- Neural Vision Restoration in Ophthalmology.Annals of biomedical engineering · 2026Review
- Stress-Based Assessment of Bio-Inspired Phosphene Vision Encoding: Trade-Offs Among Performance, Residual Proxy Safety Burden, and Topology-Based Representation Metrics.Biomimetics (Basel, Switzerland) · 2026Article
- Using Virtual Patients to Predict Perceptual Outcomes for Optogenetic Sight Recovery Technologies.Research square · 2026Article
219 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 15 institutions in 5 countries.
Funding
Abstract
purposeThis study evaluated the Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc., Sylmar, CA) in blind subjects with severe outer retinal degeneration.
designSingle-arm, prospective, multicenter clinical trial.
participantsThirty 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.
methodsThe 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 measuresThe 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.
resultsSubjects 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.
conclusionsThe 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.