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Improved performance and safety from Argus II retinal prosthesis post-approval study in France

dc.rights.licenseopenen_US
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorDELYFER, Marie-Noelle
dc.contributor.authorGAUCHER, D.
dc.contributor.authorMOHAND-SAÏD, S.
dc.contributor.authorBARALE, P. O.
dc.contributor.authorREZAIGUA-STUDER, F.
dc.contributor.authorAYELLO-SCHEER, S.
dc.contributor.authorDOLLFUS, H.
dc.contributor.authorDORN, J. D.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorKOROBELNIK, Jean-Francois
ORCID: 0000-0002-4438-9535
IDREF: 028739272
dc.contributor.authorSAHEL, J. A.
dc.date.accessioned2021-03-09T14:05:48Z
dc.date.available2021-03-09T14:05:48Z
dc.date.issued2020-12-23
dc.identifier.issn1755-3768en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/26465
dc.description.abstractEnPURPOSE: To evaluate the post-approval long-term outcomes of the Argus II Retinal Prosthesis, with a specific focus on its functional visual benefit in patients' daily activities. METHODS: Eighteen patients with bare light perception due to end-stage retinitis pigmentosa were included in a French prospective, multicentre, single-arm study and followed for 2 years. Visual benefit in patients' daily activities was monitored through the use of the Functional Low-vision Observer Rated Assessment (FLORA), and the final score at 2 years was the primary effectiveness outcome. Standardized visual assessments were also performed. Device- or procedure-related adverse events were recorded. RESULTS: Seventeen subjects completed the study. Positive impacts of the Argus II system on functional vision and well-being were demonstrated for over 70% of subjects on the FLORA. Among the daily activities/tasks tested, finding doorways was one of the most statistically significantly improved tasks (p < 0.001), along with estimating the size of an obstacle (p < 0.001), visually locating a place setting on a dining table (p < 0.001) and visually locating people in a non-crowded setting (p < 0.001). Visual function was improved on most standardized tests. Only two device- or procedure-related serious adverse events were observed (one vitreous haemorrhage and one endophthalmitis, both resolved with treatment). No explantation was required. CONCLUSION: This first report of a completed post-approval study of Argus II with a two-year follow-up demonstrates the safety and effectiveness of the Argus II System in a real-world cohort of patients and further highlights its real functional benefit in implanted patients' daily activities.
dc.language.isoENen_US
dc.title.enImproved performance and safety from Argus II retinal prosthesis post-approval study in France
dc.title.alternativeActa Ophthalmolen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1111/aos.14728en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed33354943en_US
bordeaux.journalActa Ophtalmologicaen_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - U1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.teamLEHA_BPH
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03163886
hal.version1
hal.date.transferred2021-03-09T14:05:52Z
hal.exporttrue
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