One-Year Safety and Performance Assessment of the Argus II Retinal Prosthesis
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One-Year Safety and Performance Assessment of the Argus II Retinal Prosthesis : A Postapproval Study. / Schaffrath, Kim; Schellhase, Hannah; Walter, Peter; Augustin, Albert; Chizzolini, Marzio; Kirchhof, Bernd; Grisanti, Salvatore; Wiedemann, Peter; Szurman, Peter; Richard, Gisbert; Greenberg, Robert J; Dorn, Jessy D; Parmeggiani, Francesco; Rizzo, Stanislao.
in: JAMA OPHTHALMOL, Jahrgang 137, Nr. 8, 01.08.2019, S. 896-902.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - One-Year Safety and Performance Assessment of the Argus II Retinal Prosthesis
T2 - A Postapproval Study
AU - Schaffrath, Kim
AU - Schellhase, Hannah
AU - Walter, Peter
AU - Augustin, Albert
AU - Chizzolini, Marzio
AU - Kirchhof, Bernd
AU - Grisanti, Salvatore
AU - Wiedemann, Peter
AU - Szurman, Peter
AU - Richard, Gisbert
AU - Greenberg, Robert J
AU - Dorn, Jessy D
AU - Parmeggiani, Francesco
AU - Rizzo, Stanislao
PY - 2019/8/1
Y1 - 2019/8/1
N2 - 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.
AB - 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.
U2 - 10.1001/jamaophthalmol.2019.1476
DO - 10.1001/jamaophthalmol.2019.1476
M3 - SCORING: Journal article
C2 - 31145440
VL - 137
SP - 896
EP - 902
JO - JAMA OPHTHALMOL
JF - JAMA OPHTHALMOL
SN - 2168-6165
IS - 8
ER -