Marie-Noëlle Delyfer1,2, David Gaucher3,4, Saddek Mohand-Saïd5,6, Pierre-Olivier Barale5, Fouzia Rezaigua-Studer7, Sarah Ayello-Scheer5, Hélène Dollfus7,8, Jessy D Dorn9, Jean-François Korobelnik1,2, José-Alain Sahel5,6,10,11. 1. Inserm, Bordeaux Population Health Research Center, Team LEHA, UMR1219, Univ. Bordeaux, Bordeaux, France. 2. Department of Ophthalmology, Bordeaux University Hospital, Bordeaux, France. 3. Department of Ophthalmology, NHC, University Hospital of Strasbourg, Strasbourg, France. 4. EA-7290, Institut de Bactériologie, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg, Strasbourg, France. 5. CHNO des Quinze-Vingts, DHU Sight Restore, INSERM-DGOS CIC 1423, Paris, France. 6. UPMC Univ Paris 06, INSERM U968, CNRS UMR 7210, Institut de la Vision, Sorbonne Universités, Paris, France. 7. Centre de Référence Pour les Affections Rares en Génétique Ophtalmologique, CARGO, Filière SENSGENE, Hôpitaux Universitaires de Strasbourg, Strasbourg, France. 8. Medical Genetics Laboratory, INSERM U1112, Institute of Medical Genetics of Alsace, Strasbourg Medical School, University of Strasbourg, Strasbourg, France. 9. Second Sight Medical Products, Inc., Sylmar, CA, USA. 10. Fondation Ophtalmologique Rothschild, Paris, France. 11. Department of Ophthalmology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
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.
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.
Authors: Lewis Karapanos; Carla J Abbott; Lauren N Ayton; Maria Kolic; Myra B McGuinness; Elizabeth K Baglin; Samuel A Titchener; Jessica Kvansakul; Dean Johnson; William G Kentler; Nick Barnes; David A X Nayagam; Penelope J Allen; Matthew A Petoe Journal: Transl Vis Sci Technol Date: 2021-08-12 Impact factor: 3.283
Authors: Matthew A Petoe; Samuel A Titchener; Maria Kolic; William G Kentler; Carla J Abbott; David A X Nayagam; Elizabeth K Baglin; Jessica Kvansakul; Nick Barnes; Janine G Walker; Stephanie B Epp; Kiera A Young; Lauren N Ayton; Chi D Luu; Penelope J Allen Journal: Transl Vis Sci Technol Date: 2021-08-12 Impact factor: 3.283
Authors: Carla J Abbott; Elizabeth K Baglin; Maria Kolic; Myra B McGuinness; Samuel A Titchener; Kiera A Young; Jonathan Yeoh; Chi D Luu; Lauren N Ayton; Matthew A Petoe; Penelope J Allen Journal: Transl Vis Sci Technol Date: 2022-09-01 Impact factor: 3.048