Evidence map›Paper›PMID 26162233›Full record

Trial reportOphthalmology2015

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 and 19 more

Abstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Ophthalmology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 108 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
108citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

108 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Review
  9. Neural Vision Restoration in Ophthalmology.Annals of biomedical engineering · 2026
    Review
  10. Review
  11. Motion perception with visual prostheses.Progress in biomedical engineering (Bristol, England) · 2026
    Review
  12. Review
  13. Review
  14. Review
  15. Restoration of Sight with Electronic Retinal Prostheses.Annual review of vision science · 2025
    Review
  16. Review
  17. Article
  18. Article
  19. Negative impact of internal limiting membrane peeling in vitreous hemorrhage secondary to retinal vein occlusion with macular ischemia.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025
    Article
  20. Global Treatment Approaches Part 2: Optogenetics and Retinal Implants.Advances in experimental medicine and biology · 2025
    Review

48 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors.

Allen C HoWills Eye Hospital, Philadelphia, Pennsylvania. Electronic address: acho@midatlanticretina.com.
Mark S HumayunUniversity of Southern California, Los Angeles, California.
Jessy D DornSecond Sight Medical Products, Sylmar, California.
Lyndon da CruzMoorfields Eye Hospital NHS Foundation Trust, London, United Kingdom; NHIR Moorfields Biomedical Research Centre, London, United Kingdom.
Gislin DagnelieWilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland.
James HandaWilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland.
Pierre-Olivier BaraleCentre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris, France.
José-Alain SahelCentre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris, France; ELZA Institute, Zurich, Switzerland.
Paulo E StangaManchester Royal Eye Hospital, Manchester, United Kingdom; Manchester Vision Regeneration Lab at National Institute for Health Research/Wellcome Trust Manchester CRF, Manchester, United Kingdom; Manchester Academic Health Science Centre and Centre for Ophthalmology and Vision Research, Institute of Human Development, University of Manchester, Manchester, United Kingdom.
Farhad HafeziUniversity of Southern California, Los Angeles, California; Hôpitaux Universitaires de Genève, Geneva, Switzerland; ELZA Institute, Zurich, Switzerland.
Avinoam B SafranHôpitaux Universitaires de Genève, Geneva, Switzerland; Sorbonne Universities - UPMC Paris-6, and Institut de la Vision, Paris, France.
Joel SalzmannHôpitaux Universitaires de Genève, Geneva, Switzerland.
Arturo SantosCentro de Retina Medica y Quirúrgica, SC, Guadalajara, Mexico; Tecnologico de Monterrey, Guadalajara, Mexico.
David BirchRetina Foundation of the Southwest, Dallas, Texas.
Rand SpencerTexas Retina Associates, Dallas, Texas.
Artur V CideciyanScheie Eye Institute, University of Pennsylvania, Philadelphia, Pennsylvania.
Eugene de JuanUniversity of California, San Francisco, San Francisco, California.
Jacque L DuncanUniversity of California, San Francisco, San Francisco, California.
Dean EliottUniversity of Southern California, Los Angeles, California; Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, Massachusetts.
Amani FawziUniversity of Southern California, Los Angeles, California; Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Lisa C Olmos de KooUniversity of Southern California, Los Angeles, California.
Gary C BrownWills Eye Hospital, Philadelphia, Pennsylvania.
Julia A HallerWills Eye Hospital, Philadelphia, Pennsylvania; Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland.
Carl D RegilloWills Eye Hospital, Philadelphia, Pennsylvania.
Lucian V Del PrioreColumbia University, New York, New York; Storm Eye Institute, Charleston, South Carolina.
Aries ArditiLighthouse Guild, New York, New York; Visibility Metrics, LLC, Chappaqua, New York.
Duane R GeruschatWilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland.
Robert J GreenbergSecond Sight Medical Products, Sylmar, California.
Argus II Study Group

Funding

Research/Development of Artificial Rentinas for the BlindR01EY012893 · NEI · SECOND SIGHT MEDICAL PRODUCTS, INC. · PI GREENBERG, ROBERT JAY · 2006 to 2010
$12.9M
Development and Testing of Low Vision Assessment Tools for Retinal Prostheses.RC3EY020778 · NEI · SECOND SIGHT MEDICAL PRODUCTS, INC. · PI GREENBERG, ROBERT JAY · 2010 to 2010
$3.0M
NEI NIH HHS 1RC3EY020778-01NEI NIH HHS 5R01EY012893-10NEI NIH HHS R01 EY012893NEI NIH HHS RC3 EY020778
6 · The paper itself

Abstract

purposeRetinitis 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.

designThe study is a multicenter, single-arm, prospective clinical trial.

participantsThere 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).

methodsThe 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 measuresThe primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests.

resultsA 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.

conclusionsThe 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.

Indexed as

Prosthesis ImplantationVisual ProsthesisAdultAgedBlindnessElectrodes, ImplantedFemaleFollow-Up StudiesHumansMaleMicroelectrodesMiddle AgedProspective StudiesReproducibility of ResultsRetinitis PigmentosaSingle-Blind Method

Identifiers

PMID26162233
PMCPMC4516690

What OpenQuestion holds

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Registered trials

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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.