Universität zu Köln

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 and Rizzo, Stanislao (2019). One-Year Safety and Performance Assessment of the Argus II Retinal Prosthesis: A Postapproval Study. JAMA Ophthalmol., 137 (8). S. 896 - 903. CHICAGO: AMER MEDICAL ASSOC. ISSN 2168-6173

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Abstract

Key PointsQuestionWhat are the safety and visual outcomes associated with the Argus II Retinal Prosthesis System in a postapproval cohort of patients? FindingsIn the first year of this postapproval study of 47 adults with Argus II implants, 49% experienced 51 nonserious adverse events and 26% experienced 13 serious adverse events, 9 of which were judged to be device related. On average, patients performed better on the square localization test and grating visual acuity in the implanted eye when the device was on than with it switched off. MeaningSafety and visual function outcomes in this clinical practice setting cohort of patients with Argus II implantations were consistent with previously reported results. This multicenter case series follows-up 47 patients who received the Argus II retinal prosthesis for severe to profound outer retinal degeneration to assess visual function and adverse events in the first year after implantation. ImportanceThe 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. ObjectivesTo collect postapproval safety and visual function data for the Argus II. Design, Setting, and ParticipantsMulticenter, 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 MeasuresThe 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). ResultsForty-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 RelevanceSafety 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 RegistrationClinicalTrials.gov identifier: NCT01490827

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Schaffrath, Kim UNSPECIFIED UNSPECIFIED UNSPECIFIED Schellhase, Hannah UNSPECIFIED UNSPECIFIED UNSPECIFIED Walter, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Augustin, Albert UNSPECIFIED UNSPECIFIED UNSPECIFIED Chizzolini, Marzio UNSPECIFIED UNSPECIFIED UNSPECIFIED Kirchhof, Bernd UNSPECIFIED UNSPECIFIED UNSPECIFIED Grisanti, Salvatore UNSPECIFIED UNSPECIFIED UNSPECIFIED Wiedemann, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Szurman, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Richard, Gisbert UNSPECIFIED UNSPECIFIED UNSPECIFIED Greenberg, Robert J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dorn, Jessy D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Parmeggiani, Francesco UNSPECIFIED UNSPECIFIED UNSPECIFIED Rizzo, Stanislao UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-145764
DOI:	10.1001/jamaophthalmol.2019.1476
Journal or Publication Title:	JAMA Ophthalmol.
Volume:	137
Number:	8
Page Range:	S. 896 - 903
Date:	2019
Publisher:	AMER MEDICAL ASSOC
Place of Publication:	CHICAGO
ISSN:	2168-6173
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language EPIRETINAL PROSTHESIS; VISUAL IMPAIRMENT; OLDER-ADULTS; LOW-VISION; MANAGEMENT Multiple languages Ophthalmology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/14576