1. One-Year Safety and Performance Assessment of the Argus II Retinal Prosthesis: A Postapproval Study
- Author
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Kim Schaffrath, Md, Hannah Schellhase, Md, Peter Walter, Md, Albert Augustin, Md, Marzio Chizzolini, Md, Bernd Kirchhof, Md, Salvatore Grisanti, Md, Peter Wiedemann, Md, Peter Szurman, Md, Gisbert Richard, Md, Greenberg, Robert J., Phd, Md, Jessy D. Dorn, Phd, Francesco Parmeggiani, Md, and Rizzo, Stanislao
- Subjects
Retinal degeneration ,Pediatrics ,medicine.medical_specialty ,Visual acuity ,01 natural sciences ,Prosthetics ,Visual Prosthesis ,Prosthetic vision ,NO ,03 medical and health sciences ,0302 clinical medicine ,Retinitis pigmentosa ,Clinical endpoint ,medicine ,0101 mathematics ,Adverse effect ,Original Investigation ,business.industry ,Settore MED/30 - MALATTIE APPARATO VISIVO ,010102 general mathematics ,medicine.disease ,Clinical trial ,Ophthalmology ,Visual prosthesis ,Cohort ,030221 ophthalmology & optometry ,Argus II Retinal Prosthesis System ,medicine.symptom ,business - 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
- Published
- 2019