One-Year Safety and Performance Assessment of the Argus II Retinal Prosthesis: A Postapproval Study
Open accessAbstract
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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Argus II durability generally exceeded 5 years, and the best reported grating acuity was about 1.8 logMAR (6/379 Snellen).
“The durability of the device generally exceeded 5 years and the best reported grating visual acuity is around 1.8 logMAR equivalent (6/379 Snellen) [da Cruz 2016; Schaffrath 2019].”
From Correcting visual loss by genetics and prosthetics (2020) · cites this paper as Schaffrath 2019
A multicentre trial of Argus II in end-stage retinitis pigmentosa showed that the device supports basic visual tasks such as grating acuity, high-contrast object localisation, and motion direction detection.
“A multicentre clinical trial of Argus II in patients with end-stage retinitis pigmentosa showed that the device enables basic visual tasks, such as grating visual acuity, high contrast object localisation and detection of direction of motion.”
From Correcting visual loss by genetics and prosthetics (2020) · cites this paper as Schaffrath 2019
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- Authors
- Schaffrath, K., Schellhase, H., Walter, P., Augustin, A., Chizzolini, M., Kirchhof, B., Grisanti, S., Wiedemann, P., Szurman, P., Richard, G., Greenberg, R. J., Dorn, J. D., Parmeggiani, F., & Rizzo, S.
- Affiliations
- RWTH Aachen University (DE)
- Department of Ophthalmology, Karlsruhe Memorial Hospital, Karlsruhe, Germany
- Center for Retinitis Pigmentosa of Veneto Region, Camposampiero Hospital, Padova, Italy
- University of Cologne (DE)
- University Hospital Schleswig-Holstein (DE)
- Leipzig University (DE)
- Knappschaftsklinikum Saar (DE)
- University Eye Hospital, Hamburg, Germany
- Second Sight Medical Products (US)
- University of Ferrara (IT)
- Azienda Ospedaliero-Universitaria Careggi (IT)
- Corresponding author
- Dorn, Jessy D.
- ORCID
- Venue
- JAMA Ophthalmology
- Publisher
- American Medical Association (AMA)
- Published
- 2019-08-01
- Volume
- 137
- Issue
- 8
- Pages
- 896
- ISSN
- 2168-6165 (ISSN-L)
- PMC
- PMC6547244
- OpenAlex
- W2947052483
- Cited by
- 44
- References
- 16
- Citations by year
- 2026: 8 · 2025: 9 · 2024: 5 · 2023: 3 · 2022: 3 · 2021: 7 · 2020: 7 · 2019: 2
- FWCI
- 2.27
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA Ophthalmology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Kölner Universitäts PublikationsServer (Universität zu Köln) (publishedVersion)
- RWTH Publications (RWTH Aachen) (submittedVersion)
- Institutional Research Information System University of Ferrara (University of Ferrara) (submittedVersion, other-oa)
- Topics
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neuroscience and Neural Engineering
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Retinal Development and Disorders
- Health Sciences › Medicine › Ophthalmology › Retinal Diseases and Treatments
- Keywords
- retinal prosthesis, outer retinal degeneration, retinitis pigmentosa, visual function, adverse events, conjunctival erosion, movement direction, long-term follow-up
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