Abstract
Over the past few years, visual prostheses (namely, Argus II retinal implant) and gene therapy have obtained FDA approval in treating blindness resulting from retinitis pigmentosa. Compared to gene therapy; Argus II is less costly with a demonstrated favorable outcome, though the vision is yet artificial. To obtain better results, expectation counseling and preoperative retinal assessment are critical. The global experience with Argus II has enrolled no more than 300 cases so far. The first Argus II retinal prosthesis in Iran was successfully implanted in Shiraz (October 2017). To date, Argus II artificial retina is implanted in four patients in Iran. Beside successful surgery and post-operative care, rehabilitation efforts with validated outcome measures including visual rehabilitation together with neurovisual, visuo-constructive and cognitive rehabilitation/empowerment approaches are expected to boost the functional outcome. A multidisciplinary approach within a cross-functional team would optimize strategies toward better patient outcomes. As such, establishing a collaborative network will foster organized research efforts to better define outcome assessment and rehabilitation strategies. This technology report paper has been an attempt to provide an overview of Argus-II retinal implant global experience as well as the clinical outcome of the so far cases in Iran. Insights from this report were communicated during the first “Brain Engineering and Computational Neuroscience Conference,” 31 January-2 February 2018 in Tehran.
Highlights
The inherited retinal disease known as Retinitis Pigmentosa (RP) has an estimated prevalence of 1 in 4000 worldwide (Hartong et al, 2006)
Efforts to provide RP patients with artificial vision have resulted in the development of the Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc., Sylmar, Communication Adapter (CA), USA) which acquired approvals by the European Union and the US Food and Drug Administration (FDA) in 2011 and 2013, respectively (Ghodasra et al, 2016)
Following a literature search using the combination of keywords Retinitis pigmentosa with Argus-II retinal prosthesis, neurovisual rehabilitation, programming, safety and functional outcome; an interdisciplinary team reviewed the available evidence
Summary
The inherited retinal disease known as Retinitis Pigmentosa (RP) has an estimated prevalence of 1 in 4000 worldwide (Hartong et al, 2006). There are two ongoing clinical trials i.e., the “Argus II Retinal Prosthesis System - Better Vision RP Study” and “Argus R II Retinal Stimulation System Feasibility Protocol.” These clinical trials are intended to investigate the clinical outcome measures following the implantation of the Argus II Retinal Prosthesis in patients with advanced RP who have a measurable central residual visual field smaller than or equal to 5◦ radius. The array is placed parafoveally, adjacent to the preserved central visual field (i.e., “tunnel vision”) in these subjects These two studies address some key clinical outcome measures including adverse events, visual field, visual acuity, safety, activities of daily living, quality of life, orientation and mobility, spatial vision, stability of implant, and system functionality in a 2-year (clinicaltrials.gov number NCT03418116) and 5-year (clinicaltrials.gov number NCT00407602) time- frames. The present report is an attempt to provide an overview of the elements of success in Argus-II retinal implant at global level, and to highlight the existing local experience with some remarks on the clinical outcome of the patients who have already undergone the process in Iran
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