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

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