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Original Investigation
May 30, 2019

One-Year Safety and Performance Assessment of the Argus II Retinal Prosthesis: A Postapproval Study

Author Affiliations
  • 1Department of Ophthalmology, RWTH Aachen University, Aachen, Germany
  • 2Department of Ophthalmology, Karlsruhe Memorial Hospital, Karlsruhe, Germany
  • 3Center for Retinitis Pigmentosa of Veneto Region, Camposampiero Hospital, Padova, Italy
  • 4Department of Vitreo-retinal Surgery, Center of Ophthalmology, University of Cologne, Cologne, Germany
  • 5University Eye Clinic, University Hospital Schleswig-Holstein, University of Luebeck, Luebeck, Germany
  • 6Department of Ophthalmology, Leipzig University, Leipzig, Germany
  • 7Eye Clinic Sulzbach, Knappschaft Hospital Saar, Sulzbach/Saar, Germany
  • 8University Eye Hospital, Hamburg, Germany
  • 9Second Sight Medical Products Inc, Sylmar, California
  • 10Alfred Mann Foundation for Scientific Research, Valencia, California
  • 11Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy
  • 12Department of Neuroscience, University of Florence, Florence, Italy
  • 13Department of Ophthalmology, Careggi University Hospital, Florence, Italy
JAMA Ophthalmol. Published online May 30, 2019. doi:10.1001/jamaophthalmol.2019.1476
Key Points

Question  What are the safety and visual outcomes associated with the Argus II Retinal Prosthesis System in a postapproval cohort of patients?

Findings  In 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.

Meaning  Safety and visual function outcomes in this clinical practice setting cohort of patients with Argus II implantations were consistent with previously reported results.

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.

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