title: Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind.
abstract: OBJECTIVE
  Retinitis 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.
  
  
  METHODS
  The study is a multicenter, single-arm, prospective clinical trial.
  
  
  METHODS
  There 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).
  
  
  METHODS
  The 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.
  
  
  METHODS
  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.
  
  
  RESULTS
  A 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.
  
  
  CONCLUSIONS
  The 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.
authors.affiliation: Wills Eye Hospital, Philadelphia, Pennsylvania. Electronic address: acho@midatlanticretina.com.
authors.forename: Allen C
authors.initials: AC
authors.lastname: Ho
authors.affiliation: University of Southern California, Los Angeles, California.
authors.forename: Mark S
authors.initials: MS
authors.lastname: Humayun
authors.affiliation: Second Sight Medical Products, Sylmar, California.
authors.forename: Jessy D
authors.initials: JD
authors.lastname: Dorn
authors.affiliation: Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom; NHIR Moorfields Biomedical Research Centre, London, United Kingdom.
authors.forename: Lyndon
authors.initials: L
authors.lastname: da Cruz
authors.affiliation: Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland.
authors.forename: Gislin
authors.initials: G
authors.lastname: Dagnelie
authors.affiliation: Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland.
authors.forename: James
authors.initials: J
authors.lastname: Handa
authors.affiliation: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris, France.
authors.forename: Pierre-Olivier
authors.initials: PO
authors.lastname: Barale
authors.affiliation: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris, France; ELZA Institute, Zurich, Switzerland.
authors.forename: José-Alain
authors.initials: JA
authors.lastname: Sahel
authors.affiliation: Manchester 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.
authors.forename: Paulo E
authors.initials: PE
authors.lastname: Stanga
authors.affiliation: University of Southern California, Los Angeles, California; Hôpitaux Universitaires de Genève, Geneva, Switzerland; ELZA Institute, Zurich, Switzerland.
authors.forename: Farhad
authors.initials: F
authors.lastname: Hafezi
authors.affiliation: Hôpitaux Universitaires de Genève, Geneva, Switzerland; Sorbonne Universities - UPMC Paris-6, and Institut de la Vision, Paris, France.
authors.forename: Avinoam B
authors.initials: AB
authors.lastname: Safran
authors.affiliation: Hôpitaux Universitaires de Genève, Geneva, Switzerland.
authors.forename: Joel
authors.initials: J
authors.lastname: Salzmann
authors.affiliation: Centro de Retina Medica y Quirúrgica, SC, Guadalajara, Mexico; Tecnologico de Monterrey, Guadalajara, Mexico.
authors.forename: Arturo
authors.initials: A
authors.lastname: Santos
authors.affiliation: Retina Foundation of the Southwest, Dallas, Texas.
authors.forename: David
authors.initials: D
authors.lastname: Birch
authors.affiliation: Texas Retina Associates, Dallas, Texas.
authors.forename: Rand
authors.initials: R
authors.lastname: Spencer
authors.affiliation: Scheie Eye Institute, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Artur V
authors.initials: AV
authors.lastname: Cideciyan
authors.affiliation: University of California, San Francisco, San Francisco, California.
authors.forename: Eugene
authors.initials: E
authors.lastname: de Juan
authors.affiliation: University of California, San Francisco, San Francisco, California.
authors.forename: Jacque L
authors.initials: JL
authors.lastname: Duncan
authors.affiliation: University of Southern California, Los Angeles, California; Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, Massachusetts.
authors.forename: Dean
authors.initials: D
authors.lastname: Eliott
authors.affiliation: University of Southern California, Los Angeles, California; Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
authors.forename: Amani
authors.initials: A
authors.lastname: Fawzi
authors.affiliation: University of Southern California, Los Angeles, California.
authors.forename: Lisa C
authors.initials: LC
authors.lastname: Olmos de Koo
authors.affiliation: Wills Eye Hospital, Philadelphia, Pennsylvania.
authors.forename: Gary C
authors.initials: GC
authors.lastname: Brown
authors.affiliation: Wills Eye Hospital, Philadelphia, Pennsylvania; Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland.
authors.forename: Julia A
authors.initials: JA
authors.lastname: Haller
authors.affiliation: Wills Eye Hospital, Philadelphia, Pennsylvania.
authors.forename: Carl D
authors.initials: CD
authors.lastname: Regillo
authors.affiliation: Columbia University, New York, New York; Storm Eye Institute, Charleston, South Carolina.
authors.forename: Lucian V
authors.initials: LV
authors.lastname: Del Priore
authors.affiliation: Lighthouse Guild, New York, New York; Visibility Metrics, LLC, Chappaqua, New York.
authors.forename: Aries
authors.initials: A
authors.lastname: Arditi
authors.affiliation: Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland.
authors.forename: Duane R
authors.initials: DR
authors.lastname: Geruschat
authors.affiliation: Second Sight Medical Products, Sylmar, California.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Greenberg
mesh_terms: D000328:Adult; D000368:Aged; D001766:Blindness / Q000534:rehabilitation*; D004567:Electrodes, Implanted; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008839:Microelectrodes; D008875:Middle Aged; D011446:Prospective Studies; D019919:Prosthesis Implantation; D015203:Reproducibility of Results; D012174:Retinitis Pigmentosa / Q000503:physiopathology / Q000601:surgery*; D016037:Single-Blind Method; D015354:Vision, Low / Q000534:rehabilitation*; D014792:Visual Acuity / Q000502:physiology; D057488:Visual Prosthesis