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

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 Fren...

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Published in:Acta ophthalmologica (Oxford, England) England), 2020-12
Main Authors: Delyfer, Marie-Noelle, Gaucher, D., Mohand-Saïd, S., Barale, P. O., Rezaigua-Studer, F., Ayello-Scheer, S., Dollfus, H., Dorn, J. D., Korobelnik, Jean-François, Sahel, J. A.
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container_title Acta ophthalmologica (Oxford, England)
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creator Delyfer, Marie-Noelle
Gaucher, D.
Mohand-Saïd, S.
Barale, P. O.
Rezaigua-Studer, F.
Ayello-Scheer, S.
Dollfus, H.
Dorn, J. D.
Korobelnik, Jean-François
Sahel, J. A.
description 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 
doi_str_mv 10.1111/aos.14728
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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 &lt; 0.001), along with estimating the size of an obstacle (p &lt; 0.001), visually locating a place setting on a dining table (p &lt; 0.001) and visually locating people in a non-crowded setting (p &lt; 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. 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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 &lt; 0.001), along with estimating the size of an obstacle (p &lt; 0.001), visually locating a place setting on a dining table (p &lt; 0.001) and visually locating people in a non-crowded setting (p &lt; 0.001). Visual function was improved on most standardized tests. 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title Improved performance and safety from Argus II retinal prosthesis post-approval study in France: Acta Ophthalmol
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