Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind

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dc.creatorSANTOS GARCIA, ARTURO; 15784
dc.creatorSANTOS GARCIA, ARTURO; 15784es
dc.date2015
dc.date.accessioned2018-10-18T21:22:06Z
dc.date.available2018-10-18T21:22:06Z
dc.descriptionPurpose 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. Design The study is a multicenter, single-arm, prospective clinical trial. Participants 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. Main Outcome Measures 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. © 2015 American Academy of Ophthalmology.
dc.identifier.doi10.1016/j.ophtha.2015.04.032
dc.identifier.endpage1554
dc.identifier.issn1616420
dc.identifier.issue8
dc.identifier.startpage1547
dc.identifier.urihttp://hdl.handle.net/11285/630474
dc.identifier.volume122
dc.languageeng
dc.publisherElsevier Inc.
dc.relationhttps://www.scopus.com/inward/record.uri?eid=2-s2.0-84937733842&doi=10.1016%2fj.ophtha.2015.04.032&partnerID=40&md5=099cbd1641324cdc547c5a51c5542f0a
dc.relationInvestigadores
dc.relationEstudiantes
dc.rightsinfo:eu-repo/semantics/openAccess
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0
dc.sourceOphthalmology
dc.subjectadult
dc.subjectaged
dc.subjectArticle
dc.subjectcamera
dc.subjectclinical article
dc.subjectclinical evaluation
dc.subjectconjunctival dehiscence
dc.subjectconjunctival erosion
dc.subjectcontrolled study
dc.subjectcornea opacity
dc.subjectdevice safety
dc.subjectendophthalmitis
dc.subjectEurope
dc.subjectfemale
dc.subjectfollow up
dc.subjectfunction test
dc.subjectfunctional assessment
dc.subjecthuman
dc.subjecthypotony
dc.subjectkeratitis
dc.subjectmale
dc.subjectmedical device complication
dc.subjectmulticenter study
dc.subjectoutcome assessment
dc.subjectpersonal experience
dc.subjectpriority journal
dc.subjectprospective study
dc.subjectretina detachment
dc.subjectretina tear
dc.subjectretinal implant
dc.subjectUnited States
dc.subjectuveitis
dc.subjectvision
dc.subjectvisual function test
dc.subjectblindness
dc.subjectclinical trial
dc.subjectelectrode implant
dc.subjectmicroelectrode
dc.subjectmiddle aged
dc.subjectpathophysiology
dc.subjectphysiology
dc.subjectprosthesis implantation
dc.subjectreproducibility
dc.subjectretinitis pigmentosa
dc.subjectsingle blind procedure
dc.subjectVision, Low
dc.subjectvisual acuity
dc.subjectvisual prosthesis
dc.subjectAdult
dc.subjectAged
dc.subjectBlindness
dc.subjectElectrodes, Implanted
dc.subjectFemale
dc.subjectFollow-Up Studies
dc.subjectHumans
dc.subjectMale
dc.subjectMicroelectrodes
dc.subjectMiddle Aged
dc.subjectProspective Studies
dc.subjectProsthesis Implantation
dc.subjectReproducibility of Results
dc.subjectRetinitis Pigmentosa
dc.subjectSingle-Blind Method
dc.subjectVision, Low
dc.subjectVisual Acuity
dc.subjectVisual Prosthesis
dc.subject.classification7 INGENIERÍA Y TECNOLOGÍA
dc.titleLong-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind
dc.typeArtículo
refterms.dateFOA2018-10-18T21:22:06Z

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