Improved performance and safety from Argus II retinal prosthesis post‐approval study in France
Year: 2020
Type: article
Abstract: PURPOSE: 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.
Source: Acta Ophthalmologica
DOI: 10.1111/aos.14728
Institutions: Université de Bordeaux, Inserm, Centre Hospitalier Universitaire de Bordeaux, Bordeaux Population Health, Hôpitaux Universitaires de Strasbourg, Université de Strasbourg, Centre National de la Recherche Scientifique, Institut de la Vision, Centre hospitalier national d'ophtalmologie des Quinze-Vingts, Université Pierre-et-Marie-Curie, Laboratoire de Génétique Médicale, Second Sight Medical Products, University of Pittsburgh, Fondation Ophtalmologique Adolphe de Rothschild
Language: English
Subfield: Cellular and Molecular Neuroscience
Field: Neuroscience
Domain: Life Sciences
Open Access status: bronze
OpenAlex ID: W3113410882