{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T11:39:55Z","timestamp":1792582795253,"version":"4.5.0"},"reference-count":23,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2020,12,23]],"date-time":"2020-12-23T00:00:00Z","timestamp":1608681600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acta Ophthalmologica"],"published-print":{"date-parts":[[2021,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>To evaluate the post\u2010approval long\u2010term outcomes of the Argus II Retinal Prosthesis, with a specific focus on its functional visual benefit in patients\u2019 daily activities.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Eighteen patients with bare light perception due to end\u2010stage retinitis pigmentosa were included in a French prospective, multicentre, single\u2010arm study and followed for 2\u00a0years. Visual benefit in patients\u2019 daily activities was monitored through the use of the <jats:italic>Functional Low\u2010vision Observer Rated Assessment<\/jats:italic> (FLORA), and the final score at 2\u00a0years was the primary effectiveness outcome. Standardized visual assessments were also performed. Device\u2010 or procedure\u2010related adverse events were recorded.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Seventeen subjects completed the study. Positive impacts of the Argus II system on functional vision and well\u2010being 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\u00a0&lt;\u00a00.001), along with estimating the size of an obstacle (p\u00a0&lt;\u00a00.001), visually locating a place setting on a dining table (p\u00a0&lt;\u00a00.001) and visually locating people in a non\u2010crowded setting (p\u00a0&lt;\u00a00.001). Visual function was improved on most standardized tests. Only two device\u2010 or procedure\u2010related serious adverse events were observed (one vitreous haemorrhage and one endophthalmitis, both resolved with treatment). No explantation was required.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This first report of a completed post\u2010approval study of Argus II with a two\u2010year follow\u2010up demonstrates the safety and effectiveness of the Argus II System in a real\u2010world cohort of patients and further highlights its real functional benefit in implanted patients\u2019 daily activities.<\/jats:p><\/jats:sec>","DOI":"10.1111\/aos.14728","type":"journal-article","created":{"date-parts":[[2020,12,24]],"date-time":"2020-12-24T13:30:38Z","timestamp":1608816638000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Improved performance and safety from Argus II retinal prosthesis post\u2010approval study in France"],"prefix":"10.1111","volume":"99","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3127-8617","authenticated-orcid":false,"given":"Marie\u2010No\u00eblle","family":"Delyfer","sequence":"first","affiliation":[{"name":"Inserm Bordeaux Population Health Research Center Team LEHA UMR1219 Univ. Bordeaux Bordeaux France"},{"name":"Department of Ophthalmology Bordeaux University Hospital Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Gaucher","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology NHC University Hospital of Strasbourg Strasbourg France"},{"name":"EA\u20107290 Institut de Bacte\u0301riologie Fe\u0301de\u0301ration de Me\u0301decine Translationnelle de Strasbourg Universite\u0301 de Strasbourg Strasbourg France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saddek","family":"Mohand\u2010Sa\u00efd","sequence":"additional","affiliation":[{"name":"CHNO des Quinze\u2010Vingts DHU Sight Restore INSERM\u2010DGOS CIC 1423 Paris France"},{"name":"UPMC Univ Paris 06 INSERM U968 CNRS UMR 7210 Institut de la Vision Sorbonne Universite\u0301s Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre\u2010Olivier","family":"Barale","sequence":"additional","affiliation":[{"name":"CHNO des Quinze\u2010Vingts DHU Sight Restore INSERM\u2010DGOS CIC 1423 Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fouzia","family":"Rezaigua\u2010Studer","sequence":"additional","affiliation":[{"name":"Centre de Re\u0301fe\u0301rence Pour les Affections Rares en Ge\u0301ne\u0301tique Ophtalmologique, CARGO Fili\u00e8re SENSGENE H\u00f4pitaux Universitaires de Strasbourg Strasbourg France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Ayello\u2010Scheer","sequence":"additional","affiliation":[{"name":"CHNO des Quinze\u2010Vingts DHU Sight Restore INSERM\u2010DGOS CIC 1423 Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"He\u0301l\u00e8ne","family":"Dollfus","sequence":"additional","affiliation":[{"name":"Centre de Re\u0301fe\u0301rence Pour les Affections Rares en Ge\u0301ne\u0301tique Ophtalmologique, CARGO Fili\u00e8re SENSGENE H\u00f4pitaux Universitaires de Strasbourg Strasbourg France"},{"name":"Medical Genetics Laboratory INSERM U1112 Institute of Medical Genetics of Alsace Strasbourg Medical School University of Strasbourg Strasbourg France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessy D.","family":"Dorn","sequence":"additional","affiliation":[{"name":"Second Sight Medical Products, Inc. Sylmar CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean\u2010Fran\u00e7ois","family":"Korobelnik","sequence":"additional","affiliation":[{"name":"Inserm Bordeaux Population Health Research Center Team LEHA UMR1219 Univ. Bordeaux Bordeaux France"},{"name":"Department of Ophthalmology Bordeaux University Hospital Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose\u0301\u2010Alain","family":"Sahel","sequence":"additional","affiliation":[{"name":"CHNO des Quinze\u2010Vingts DHU Sight Restore INSERM\u2010DGOS CIC 1423 Paris France"},{"name":"UPMC Univ Paris 06 INSERM U968 CNRS UMR 7210 Institut de la Vision Sorbonne Universite\u0301s Paris France"},{"name":"Fondation Ophtalmologique Rothschild Paris France"},{"name":"Department of Ophthalmology University of Pittsburgh School of Medicine Pittsburgh PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,12,23]]},"reference":[{"key":"e_1_2_5_2_1","doi-asserted-by":"publisher","DOI":"10.1167\/iovs.09-3512"},{"key":"e_1_2_5_3_1","doi-asserted-by":"publisher","DOI":"10.1088\/1741-2560\/13\/2\/025003"},{"key":"e_1_2_5_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12916-014-0181-7"},{"key":"e_1_2_5_5_1","doi-asserted-by":"publisher","DOI":"10.1136\/bjophthalmol-2012-301525"},{"key":"e_1_2_5_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2016.06.049"},{"key":"e_1_2_5_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/aos.12335"},{"key":"e_1_2_5_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.oret.2017.08.010"},{"key":"e_1_2_5_9_1","doi-asserted-by":"publisher","DOI":"10.1001\/2013.jamaophthalmol.221"},{"key":"e_1_2_5_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/cxo.12242"},{"key":"e_1_2_5_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/cxo.12359"},{"key":"e_1_2_5_12_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12886-016-0225-1"},{"key":"e_1_2_5_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2015.04.032"},{"key":"e_1_2_5_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2011.09.028"},{"key":"e_1_2_5_15_1","doi-asserted-by":"publisher","DOI":"10.1136\/bjo.82.9.1083"},{"key":"e_1_2_5_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/bs.pbr.2017.03.003"},{"key":"e_1_2_5_17_1","doi-asserted-by":"publisher","DOI":"10.3389\/fnins.2017.00174"},{"key":"e_1_2_5_18_1","doi-asserted-by":"publisher","DOI":"10.1097\/IAE.0000000000002818"},{"key":"e_1_2_5_19_1","doi-asserted-by":"publisher","DOI":"10.1097\/IAE.0000000000002394"},{"key":"e_1_2_5_20_1","doi-asserted-by":"publisher","DOI":"10.1136\/bjophthalmol-2019-314135"},{"key":"e_1_2_5_21_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaophthalmol.2019.1476"},{"key":"e_1_2_5_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.preteyeres.2018.03.005"},{"key":"e_1_2_5_23_1","doi-asserted-by":"publisher","DOI":"10.24141\/1\/2\/2\/3"},{"key":"e_1_2_5_24_1","doi-asserted-by":"publisher","DOI":"10.1109\/TBME.2014.2314733"}],"container-title":["Acta Ophthalmologica"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/aos.14728","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/aos.14728","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/aos.14728","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,29]],"date-time":"2023-08-29T19:53:28Z","timestamp":1693338808000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/aos.14728"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,12,23]]},"references-count":23,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2021,11]]}},"alternative-id":["10.1111\/aos.14728"],"URL":"https:\/\/doi.org\/10.1111\/aos.14728","archive":["Portico"],"relation":{},"ISSN":["1755-375X","1755-3768"],"issn-type":[{"value":"1755-375X","type":"print"},{"value":"1755-3768","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,12,23]]},"assertion":[{"value":"2020-05-12","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-11-29","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-12-23","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}