Show simple item record

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

dc.creatorARTURO SANTOS GARCIA;15784
dc.creatorARTURO SANTOS GARCIA;15784es
dc.date2016
dc.date.accessioned2018-10-18T20:34:48Z
dc.date.available2018-10-18T20:34:48Z
dc.identifier.issn1616420
dc.identifier.doi10.1016/j.ophtha.2016.06.049
dc.identifier.urihttp://hdl.handle.net/11285/630362
dc.descriptionPurpose The 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. Design Prospective, 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. Participants Thirty participants in 10 centers in the United States and Europe. Methods The 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 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. Secondary measures included functional vision performance on objectively scored real-world tasks. Results Twenty-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. Conclusions The 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. © 2016 American Academy of Ophthalmology
dc.languageeng
dc.publisherElsevier Inc.
dc.relationhttps://www.scopus.com/inward/record.uri?eid=2-s2.0-84979230981&doi=10.1016%2fj.ophtha.2016.06.049&partnerID=40&md5=fcfcbbb19697aa00d4ee443de89277cc
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.subjectaudiovisual equipment
dc.subjectblindness
dc.subjectclinical article
dc.subjectclinical effectiveness
dc.subjectconjunctiva disease
dc.subjectconjunctival dehiscence
dc.subjectconjunctival erosion
dc.subjectcontrolled clinical trial (topic)
dc.subjectcontrolled study
dc.subjectcornea disease
dc.subjectcornea opacity
dc.subjectcorneal melt
dc.subjectdevice safety
dc.subjectelectrode
dc.subjectendophthalmitis
dc.subjecterosion
dc.subjectEurope
dc.subjectfemale
dc.subjectfollow up
dc.subjecthuman
dc.subjectintraocular hypotension
dc.subjectiris rubeosis
dc.subjectkeratitis
dc.subjectmale
dc.subjectmedical electronics
dc.subjectmulticenter study (topic)
dc.subjectneovascular glaucoma
dc.subjectophthalmic camera
dc.subjectophthalmological surgical equipment
dc.subjectoutcome assessment
dc.subjectpatient safety
dc.subjectpriority journal
dc.subjectquality of life
dc.subjectretina degeneration
dc.subjectretina detachment
dc.subjectretina image
dc.subjectretina tear
dc.subjectretinal implant
dc.subjectretinitis pigmentosa
dc.subjectspectacles
dc.subjectsuture
dc.subjectUnited States
dc.subjectuveitis
dc.subjectvision
dc.subjectblindness
dc.subjectclinical trial
dc.subjectcomplication
dc.subjectmiddle aged
dc.subjectmulticenter study
dc.subjectpathology
dc.subjectpathophysiology
dc.subjectprospective study
dc.subjectprosthesis design
dc.subjectrehabilitation
dc.subjectretina
dc.subjectretinitis pigmentosa
dc.subjecttime factor
dc.subjecttreatment outcome
dc.subjectvisual acuity
dc.subjectvisual prosthesis
dc.subjectvisually impaired person
dc.subjectAdult
dc.subjectAged
dc.subjectBlindness
dc.subjectFemale
dc.subjectFollow-Up Studies
dc.subjectHumans
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectProspective Studies
dc.subjectProsthesis Design
dc.subjectRetina
dc.subjectRetinitis Pigmentosa
dc.subjectTime Factors
dc.subjectTreatment Outcome
dc.subjectVisual Acuity
dc.subjectVisual Prosthesis
dc.subjectVisually Impaired Persons
dc.subject.classification7 INGENIERÍA Y TECNOLOGÍA
dc.titleFive-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial
dc.typeArtículo
dc.identifier.volume123
dc.identifier.issue10
dc.identifier.startpage2248
dc.identifier.endpage2254
refterms.dateFOA2018-10-18T20:34:48Z


Files in this item

Thumbnail
Name:
84979230981.pdf
Size:
381.8Kb
Format:
PDF
Description:
Abstract
View/Open

This item appears in the following Collection(s)

Show simple item record

info:eu-repo/semantics/openAccess
Except where otherwise noted, this item's license is described as info:eu-repo/semantics/openAccess