An analysis of observer‐rated functional vision in patients implanted with the Argus II Retinal Prosthesis System at three years

Geruschat, Duane R.; Richards, Thomas P.; Arditi, Aries; Cruz, Lyndon da; Dagnelie, Gislin; Dorn, Jessy D.; Duncan, Jacque L.; Ho, Allen C.; Koo, Lisa C. Olmos de; Sahel, José‐Alain; Stanga, Paulo E; Thumann, Gabriele; Wang, Vizhong; Greenberg, Robert J.

doi:10.1111/cxo.12359

Cited by 50 publications

(60 citation statements)

References 13 publications

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“…The FLORA and VisQoL were performed only through post-implant year 3 (as per the clinical trial protocol), and the FLORA has been described and reported elsewhere. 10,11 The Activity Inventory was not fully validated in this patient population (e.g., with very low vision patients) and as such the data are not included in this report.…”

Section: Methodsmentioning

confidence: 99%

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

et al. 2016

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Purpose The Argus® II Retinal Prosthesis System (Second Sight Medical Products, Inc., Sylmar, CA) was developed to restore some vision to patients blind from 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 due to end-stage RP. Design The study is a prospective, multicenter, single-arm, clinical trial. Within-patient controls included the non-implanted fellow eye and patients' native residual vision compared to their vision when using the System. Subjects There were 30 subjects in 10 centers in the U.S. and Europe. Methods The worse-seeing eye of blind patients was implanted with the Argus II System. 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. Main Outcome Measures The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by three computer-based, objective tests. Secondary measures included functional vision performance on objectively-scored real-world tasks. Results Twenty-four out of 30 patients remained implanted with functioning Argus II Systems at 5 years post-implant. Only one additional serious adverse event was experienced since the 3-year time point. Patients performed significantly better with the System ON than OFF on all visual function tests and functional vision tasks. Conclusions The five-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind from 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.

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Section: Methodsmentioning

confidence: 99%

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

et al. 2016

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“…A light-sensitive electrode is surgically implanted onto the retina and the patient wears glasses with a mounted camera, which transmits signals to the retinal electrode and these signals are then relayed to the brain. The Argus® II Retinal Stimulation System (Second Sight Medical Products, Sylmar, CA, USA), aptly named after the hundred-eyed giant in Greek mythology, has FDA approval for patients with advanced RP, and has shown improvement in patients’ accuracy and repeatability of vision-related tasks (Ahuja et al, 2011; Geruschat et al, 2016; Yue et al, 2015), though a high number of patients (11/30) were shown to have severe adverse effects three years after electrode implantation (Ho et al, 2015). Another route for transplantation strategies is intravitreal delivery of pharmacologics.…”

Section: Retinal Degenerative Diseases (Rdds)mentioning

confidence: 99%

Cell-based therapeutic strategies for replacement and preservation in retinal degenerative diseases

Jones

Lü

Girman

et al. 2017

Progress in Retinal and Eye Research

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Cell-based therapeutics offer diverse options for treating retinal degenerative diseases, such as age-related macular degeneration (AMD) and retinitis pigmentosa (RP). AMD is characterized by both genetic and environmental risks factors, whereas RP is mainly a monogenic disorder. Though treatments exist for some patients with neovascular AMD, a majority of retinal degenerative patients have no effective therapeutics, thus indicating a need for universal therapies to target diverse patient populations. Two main cell-based mechanistic approaches are being tested in clinical trials. Replacement therapies utilize cell-derived retinal pigment epithelial (RPE) cells to supplant lost or defective host RPE cells. These cells are similar in morphology and function to native RPE cells and can potentially supplant the responsibilities of RPE in vivo. Preservation therapies utilize supportive cells to aid in visual function and photoreceptor preservation partially by neurotrophic mechanisms. The goal of preservation strategies is to halt or slow the progression of disease and maintain remaining visual function. A number of clinical trials are testing the safety of replacement and preservation cell therapies in patients; however, measures of efficacy will need to be further evaluated. In addition, a number of prevailing concerns with regards to the immune-related response, longevity, and functionality of the grafted cells will need to be addressed in future trials. This review will summarize the current status of cell-based preclinical and clinical studies with a focus on replacement and preservation strategies and the obstacles that remain regarding these types of treatments.

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“…Efficacy was established from three computer‐based, objective tests of basic visual skills, intended to measure incremental changes in a low‐vision population. Functional vision or the ability to complete everyday tasks, was also measured with the device turned both on and off …”

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confidence: 99%

Improvements in vision‐related quality of life in blind patients implanted with the Argus II Epiretinal Prosthesis

Duncan

Richards²,

Arditi

et al. 2017

Clinical and Experimental Optometry

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BackgroundThe purpose of this analysis is to report the change in quality of life (QoL) after treatment with the Argus II Epiretinal Prosthesis in patients with end‐stage retinitis pigmentosa.MethodsThe Vision and Quality of Life Index (VisQoL) was used to assess changes in QoL dimensions and overall utility score in a prospective 30‐patient single‐arm clinical study. VisQoL is a multi‐attribute instrument consisting of six dimensions (injury, life, roles, assistance, activity and friendship) that may be affected by visual impairment. Within each dimension, patients were divided into two groups based on how much their QoL was affected by their blindness at baseline (moderate/severe or minimal). Outcomes were compared within each dimension sub‐group between baseline and the combined follow‐up periods using the Friedman test. In addition, data from the six dimensions were combined into a single utility score, with baseline data compared to the combined follow‐up periods.ResultsOverall, 80 per cent of the patients reported difficulty in one or more dimensions pre‐implant. Composite VisQoL utility scores at follow‐up showed no statistically significant change from baseline; however, in three of the six VisQoL dimensions (injury, life and roles), patients with baseline deficits showed significant and lasting improvement after implantation with Argus II. In two of the three remaining dimensions (assistance and activity), data trended toward an improvement. In the final VisQoL dimension (friendship), none of the patients reported baseline deficits, suggesting that patients had largely adjusted to this attribute.ConclusionPatients whose vision negatively affected them with respect to three VisQoL dimensions (that is, getting injured, coping with the demands of their life and fulfilling their life roles) reported significant improvement in QoL after implantation of the Argus II retinal prosthesis. Furthermore, the benefit did not deteriorate at any point during the 36‐month follow‐up, suggesting a long‐term, durable improvement.

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An analysis of observer‐rated functional vision in patients implanted with the Argus II Retinal Prosthesis System at three years

Cited by 50 publications

References 13 publications

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

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

Cell-based therapeutic strategies for replacement and preservation in retinal degenerative diseases

Improvements in vision‐related quality of life in blind patients implanted with the Argus II Epiretinal Prosthesis

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