Original articleVisual Performance Using a Retinal Prosthesis in Three Subjects With Retinitis Pigmentosa
Section snippets
Methods
This study protocol was granted an Investigational Device Exemption by the US Food and Drug Administration and was approved by the Institutional Review Board at the University of Southern California. This research adhered to the tenets of the Declaration of Helsinki. The trial is registered at the National Institutes of Health (trial identifier NCT00279500).
Experiments Using Computer Input
Subjects scored better than chance in eight of nine computer-controlled experiments (see Figure 2). When asked to identify which of two electrodes had been presented (experiment 1), all of the subjects performed significantly better than chance (S1 = 72%, S2 = 100%, S3 = 67%; P < .01). This suggested that the percepts elicited by individual electrodes remain reasonably consistent over short periods. In experiment 2 (sequential activation of paired electrodes), all three subjects performed
Discussion
The safety and feasibility of microelectronic implants has been supported by several recent studies, and the relative merits of epiretinal and subretinal retinal implants vs other approaches such as optic nerve cuffs and cortical implants has been extensively discussed in the literature.5, 6 Recent clinical trials of retinal implants have included a passive subretinal device, an active subretinal device (Zrenner E, et al. IOVS 2006;47: ARVO E-Abstract 1538), and an active epiretinal device
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