Evidence map›Paper›PMID 27453256›Full record

Trial reportOphthalmology2016

Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial.

Lyndon da Cruz, Jessy D Dorn, Mark S Humayun, Gislin Dagnelie, James Handa, Pierre-Olivier Barale, José-Alain Sahel, Paulo E Stanga, Farhad Hafezi, Avinoam B Safran and 18 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Ophthalmology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05914233 (Revolutionary Non-Invasive Ultrasound Technology for Vision Restoration in Age-Related Macular Degeneration), which is not on this map. Cited by 176 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
176citing 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.

NCT05914233 nanot yet recruitingnot on this mapstarted 2027, after this paper: background citation

Revolutionary Non-Invasive Ultrasound Technology for Vision Restoration in Age-Related Macular Degeneration (AMD) and Retinitis Pigmentosa (RP) Patients

TypeinterventionalSponsorUniversity of Southern CaliforniaRan2027 to 2028Enrolled5ConditionsAge-Related Macular Degeneration, Retinitis Pigmentosa, Ultrasound Therapy, ComplicationsArmsNon-invasive ultrasound retinal stimulation Device
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Motion perception with visual prostheses.Progress in biomedical engineering (Bristol, England) · 2026
    Review
  15. Article
  16. Article
  17. Review
  18. Article
  19. Review
  20. Article

116 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

28 authors.

Lyndon da CruzDepartment of Vitreoretinal Surgery, Moorfields Eye Hospital, NHS Foundation Trust, NIHR Moorfields Biomedical Research Centre, London, United Kingdom and Department of Brain Science, University College London (UCL).
Jessy D DornSecond Sight Medical Products, Inc, Sylmar, California. Electronic address: jdorn@secondsight.com.
Mark S HumayunUniversity of Southern California, Los Angeles, California.
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; Sorbonne Universities-UPMC Paris-6, and Institut de la Vision, Paris, France; Rothschild Ophthalmology Foundation, Paris, France.
Paulo E StangaManchester Royal Eye Hospital, Manchester Vision Regeneration (MVR) Laboratory at NIHR/Wellcome Trust Manchester CRF, and 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; ELZA Institute, Zurich, Switzerland; Hôpitaux Universitaires de Genève, Geneva, Switzerland.
Avinoam B SafranSorbonne Universities-UPMC Paris-6, and Institut de la Vision, Paris, France; Hôpitaux Universitaires de Genève, Geneva, Switzerland.
Joel SalzmannHôpitaux Universitaires de Genève, Geneva, Switzerland.
Arturo SantosCentro de Retina Medica y Quirúrgica, SC, and 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.
Allen C HoWills Eye Hospital, Philadelphia, Pennsylvania.
Gary BrownWills Eye Hospital, Philadelphia, Pennsylvania.
Julia HallerWilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland; Wills Eye Hospital, Philadelphia, Pennsylvania.
Carl RegilloWills Eye Hospital, Philadelphia, Pennsylvania.
Lucian V Del PrioreColumbia University, New York, and Storm Eye Institute, Charleston, South Carolina.
Aries ArditiLighthouse Guild, New York, and Visibility Metrics, LLC, Chappaqua, New York.
Robert J GreenbergSecond Sight Medical Products, Inc, 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 R01 EY012893NEI NIH HHS RC3 EY020778
6 · The paper itself

Abstract

purposeThe 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.

designProspective, 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.

participantsThirty participants in 10 centers in the United States and Europe.

methodsThe 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 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. Secondary measures included functional vision performance on objectively scored real-world tasks.

resultsTwenty-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.

conclusionsThe 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.

Indexed as

Visual AcuityVisual ProsthesisAdultAgedBlindnessFemaleFollow-Up StudiesHumansMaleMiddle AgedPersons with Visual DisabilitiesProspective StudiesProsthesis DesignRetinaRetinitis PigmentosaTime Factors

Identifiers

PMID27453256
PMCPMC5035591

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.