Kim Schaffrath1, Hannah Schellhase1, Peter Walter1, Albert Augustin2, Marzio Chizzolini3, Bernd Kirchhof4, Salvatore Grisanti5, Peter Wiedemann6, Peter Szurman7, Gisbert Richard8, Robert J Greenberg9,10, Jessy D Dorn9, Francesco Parmeggiani3,11, Stanislao Rizzo12,13. 1. Department of Ophthalmology, RWTH Aachen University, Aachen, Germany. 2. Department of Ophthalmology, Karlsruhe Memorial Hospital, Karlsruhe, Germany. 3. Center for Retinitis Pigmentosa of Veneto Region, Camposampiero Hospital, Padova, Italy. 4. Department of Vitreo-retinal Surgery, Center of Ophthalmology, University of Cologne, Cologne, Germany. 5. University Eye Clinic, University Hospital Schleswig-Holstein, University of Luebeck, Luebeck, Germany. 6. Department of Ophthalmology, Leipzig University, Leipzig, Germany. 7. Eye Clinic Sulzbach, Knappschaft Hospital Saar, Sulzbach/Saar, Germany. 8. University Eye Hospital, Hamburg, Germany. 9. Second Sight Medical Products Inc, Sylmar, California. 10. Alfred Mann Foundation for Scientific Research, Valencia, California. 11. Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy. 12. Department of Neuroscience, University of Florence, Florence, Italy. 13. Department of Ophthalmology, Careggi University Hospital, Florence, Italy.
Abstract
IMPORTANCE: The Argus II Retinal Prosthesis System is indicated for patients with vision loss due to severe to profound outer retinal degeneration, a group with few treatment options. OBJECTIVES: To collect postapproval safety and visual function data for the Argus II. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, postapproval clinical trial conducted at 9 sites in Germany and Italy. Data were collected from December 2, 2011, to September 30, 2017, and patients were followed-up for 12 months or longer. Patients were 25 years or older with severe to profound outer retinal degeneration, some residual light perception or the ability of the retina to respond to electrical stimulation, and a history of useful form vision and were already planning to undergo Argus II implantation. MAIN OUTCOMES AND MEASURES: The primary end point of this study was the nature and rate of adverse events. Secondary end points included 3 visual function tests: square localization (SL), direction of motion, and grating visual acuity (GVA). RESULTS: Forty-seven patients were followed for 12 months or longer after implant. Mean (SD) age was 56 (12) years, 37 (79%) had retinitis pigmentosa, and 27 (57%) were male. Through the first 12 months postimplantation, 23 patients (49%) experienced 51 nonserious adverse events and 12 (26%) experienced 13 serious adverse events (SAEs), 9 of which were judged to be related to the Argus II, and 4 of which were judged to be related to the procedure. The most common SAE was conjunctival erosion, reported in 4 patients. No significance testing was done for group analysis for the SL or direction-of-motion tests. When averaged across the group, patients' accuracy on the SL test, but not on the direction-of-motion test, appeared better when the Argus II was on than when it was switched off. For GVA, more patients at each point in time achieved the 2.9 GVA cutoff in the implanted eye when the Argus II was on compared with it switched off. CONCLUSIONS AND RELEVANCE: Safety and visual function outcomes in this clinical practice setting cohort of patients with Argus II implants were consistent with previously reported results. Longer follow-up of these patients and data from additional patients are required to better outline the risks and benefits of this approach to addressing blindness secondary to severe-to-profound outer retinal degeneration. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01490827.
IMPORTANCE: The Argus II Retinal Prosthesis System is indicated for patients with vision loss due to severe to profound outer retinal degeneration, a group with few treatment options. OBJECTIVES: To collect postapproval safety and visual function data for the Argus II. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, postapproval clinical trial conducted at 9 sites in Germany and Italy. Data were collected from December 2, 2011, to September 30, 2017, and patients were followed-up for 12 months or longer. Patients were 25 years or older with severe to profound outer retinal degeneration, some residual light perception or the ability of the retina to respond to electrical stimulation, and a history of useful form vision and were already planning to undergo Argus II implantation. MAIN OUTCOMES AND MEASURES: The primary end point of this study was the nature and rate of adverse events. Secondary end points included 3 visual function tests: square localization (SL), direction of motion, and grating visual acuity (GVA). RESULTS: Forty-seven patients were followed for 12 months or longer after implant. Mean (SD) age was 56 (12) years, 37 (79%) had retinitis pigmentosa, and 27 (57%) were male. Through the first 12 months postimplantation, 23 patients (49%) experienced 51 nonserious adverse events and 12 (26%) experienced 13 serious adverse events (SAEs), 9 of which were judged to be related to the Argus II, and 4 of which were judged to be related to the procedure. The most common SAE was conjunctival erosion, reported in 4 patients. No significance testing was done for group analysis for the SL or direction-of-motion tests. When averaged across the group, patients' accuracy on the SL test, but not on the direction-of-motion test, appeared better when the Argus II was on than when it was switched off. For GVA, more patients at each point in time achieved the 2.9 GVA cutoff in the implanted eye when the Argus II was on compared with it switched off. CONCLUSIONS AND RELEVANCE: Safety and visual function outcomes in this clinical practice setting cohort of patients with Argus II implants were consistent with previously reported results. Longer follow-up of these patients and data from additional patients are required to better outline the risks and benefits of this approach to addressing blindness secondary to severe-to-profound outer retinal degeneration. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01490827.
Authors: Jana Gehlen; Stefan Esser; Kim Schaffrath; Sandra Johnen; Peter Walter; Frank Müller Journal: Invest Ophthalmol Vis Sci Date: 2020-11-02 Impact factor: 4.799
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