Update and revision of the entire rationale using a literature search through July 2011.
Second Sight Medical Products reports that the Argus 16 was implanted in six subjects with retinitis pigmentosa between 2002 and 2004; the study is ongoing with five of six subjects wearing the retinal prosthesis at home. The company is currently recruiting 30 subjects for a National Institutes of Health-sponsored Phase II multicenter safety and effectiveness study of the second generation Argus II Retinal Stimulation System.
Initial results from the Phase I/II study of the Argus 16 devices, implanted between 2002 and 2004, had been published. Two publications were with the Argus™ II (60 electrode) device, one of which was a conference proceeding. Preliminary six-month results in 17 subjects showed improvement in high-contrast localization and orientation. For example, the success rate of reaching a door improved from 32% with the system off to 59% with the system on. The average success rates of following a white line on a dark floor improved from 26% to 44%, respectively. Localization of a high-contrast target on a computer monitor was also found to improve with the Argus™ II in 27 subjects implanted with the device.
In a summary of their work, Chader et al. (2009) reported that the 60-electrode device is currently in a Phase II/III clinical trial, a 250-electrode unit is “on the drawing board,” and functional vision with a thousand electrode prosthesis could potentially be achieved within 5-10 years. Initial results from a four-week implantation study of another retinal prosthesis, the EPI-RET-3, have also been reported.
No device has final U.S. Food and Drug Administration (FDA) approval. This treatment is considered experimental, investigational and unproven.
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