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Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial.

ABSTRACT: The Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) was developed to restore some vision to patients blind as a result of retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception resulting from end-stage RP.Prospective, multicenter, single-arm clinical trial. Within-patient controls included the nonimplanted fellow eye and patients' native residual vision compared with their vision with the Argus II.Thirty participants in 10 centers in the United States and Europe.The worse-seeing eye of blind patients was implanted with the Argus II. Patients wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina.The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests. Secondary measures included functional vision performance on objectively scored real-world tasks.Twenty-four of 30 patients remained implanted with functioning Argus II Systems at 5 years after implantation. Only 1 additional serious adverse event was experienced after the 3-year time point. Patients performed significantly better with the Argus II on than off on all visual function tests and functional vision tasks.The 5-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind as a result of RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada.

SUBMITTER: da Cruz L

PROVIDER: S-EPMC5035591 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial.

da Cruz Lyndon L Dorn Jessy D JD Humayun Mark S MS Dagnelie Gislin G Handa James J Barale Pierre-Olivier PO Sahel José-Alain JA Stanga Paulo E PE Hafezi Farhad F Safran Avinoam B AB Salzmann Joel J Santos Arturo A Birch David D Spencer Rand R Cideciyan Artur V AV de Juan Eugene E Duncan Jacque L JL Eliott Dean D Fawzi Amani A Olmos de Koo Lisa C LC Ho Allen C AC Brown Gary G Haller Julia J Regillo Carl C Del Priore Lucian V LV Arditi Aries A Greenberg Robert J RJ

Ophthalmology 20160721 10

<h4>Purpose</h4>The Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) was developed to restore some vision to patients blind as a result of retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception resulting from end-stage RP.<h4>Design</h4>Prospective, multicenter, single-arm clinical trial. Within-patient controls ...[more]

PMID: 27453256

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Project description: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.

Project description:PURPOSE:The Argus II epiretinal prosthesis has been developed to provide partial restoration of vision to subjects blinded from outer retinal degenerative disease. Participants were surgically implanted with the system in the United States and Europe in a single arm, prospective, multicenter clinical trial. The purpose of this investigation was to determine which factors affect electrical thresholds in order to inform surgical placement of the device. METHODS:Electrode-retina and electrode-fovea distances were determined using SD-OCT and fundus photography, respectively. Perceptual threshold to electrical stimulation of electrodes was measured using custom developed software, in which current amplitude was varied until the threshold was found. Full field stimulus light threshold was measured using the Espion D-FST test. Relationships between electrical threshold and these three explanatory variables (electrode-retina distance, electrode-fovea distance, and monocular light threshold) were quantified using regression. RESULTS:Regression analysis showed a significant correlation between electrical threshold and electrode-retina distance (R2 = 0.50, P = 0.0002; n = 703 electrodes). 90.3% of electrodes in contact with the macula (n = 207) elicited percepts at charge densities less than 1 mC/cm2/phase. These threshold data also correlated well with ganglion cell density profile (P = 0.03). A weaker, but still significant, inverse correlation was found between light threshold and electrical threshold (R2 < 0.52, P = 0.01). Multivariate modeling indicated that electrode-retina distance and light threshold are highly predictive of electrode threshold (R2 = 0.87; P < 0.0005). CONCLUSIONS:Taken together, these results suggest that while light threshold should be used to inform patient selection, macular contact of the array is paramount. TRANSLATIONAL RELEVANCE:Reported Argus II clinical study results are in good agreement with prior in vitro and in vivo studies, and support the development of higher-density systems that employ smaller diameter electrodes. (clinicaltrials.gov identifier: NCT00407602).

Project description:INTRODUCTION:Most visual neuroprostheses use an external camera for image acquisition. This adds two complications to phosphene perception: (1) stimulation locus will not change with eye movements; and (2) external cameras can be aimed in directions different from the user's intended direction of gaze. Little is known about the stability of where users perceive light sources to be or whether they will adapt to changes in camera orientation. METHODS:Three end-stage retinitis pigmentosa patients implanted with the Argus II participated in this study. This prosthesis stimulated the retina based on an 18° × 11° area selected within the camera's 66° × 49° field of view. The center of the electrode array's field of view mapped within the camera's field of view is the camera alignment position (CAP). Proper camera alignments minimize errors in localizing visual percepts in space. Subjects touched single white squares in random locations on a darkened touchscreen 40 or more times. To study adaptation, subjects were given intentional CAP misalignments of 15-40° for 5-6 months. Subjects performed this test with auditory feedback during (bi-)weekly lab sessions. Misaligned CAPs were maintained for another 5-6 months without auditory feedback. Touch alignment was tracked to detect any adaptation. To estimate localization stability, data for when CAPs were set to minimize errors were tracked. The same localization test as above was used. Localization errors were tracked every 1-2 weeks for up to 40 months. RESULTS:Two of three subjects used auditory feedback to improve accuracy with misaligned CAPs at an average rate of 0.02°/day (p < 0.05, bootstrap analysis of linear regression). The rates observed here were ~4000 times slower than those seen in normally-sighted subjects adapting to prism glasses. Removal of auditory feedback precipitated error increases for all subjects. Optimal CAPs varied significantly across test sessions (p < 10(-4), bootstrap multivariate analysis of variance (MANOVA)), up to 21-29° within subjects over the observed period. Across subjects, optimal CAPs showed an average rate of change of 0.39°/day (SD 0.36°/day). CONCLUSIONS:Optimal CAPs varied dramatically over time for all subjects. Subjects displayed no adaptation to misaligned CAPs without feedback. Regular recalibration of CAPs may be required to maintain hand-camera coordination.

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Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial.

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Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial.

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