Visual performance using a retinal prosthesis in three subjects with retinitis pigmentosa

PURPOSE: To assess visual task performance in three blind subjects implanted with epiretinal prostheses. DESIGN: Prospective, investigational device exemption trial. METHODS: Three subjects with light perception or no light perception vision were enrolled at a single center. All subjects had retinitis pigmentosa (RP). Main inclusion criteria: light perception or worse vision in one eye and some visual experience as an adult before blindness. Main exclusion criteria included other ophthalmic problems. A prototype retinal prosthesis was implanted in the eye with worse light sensitivity. The prosthesis had 4 x 4 array of platinum electrodes tacked to the epiretinal surface. The prosthesis was wirelessly controlled by a computer or by a head-worn video camera. Visual function testing was performed in single masked or double masked fashion. Scores from the visual task were compared to chance to determine statistical significance. RESULTS: The subjects performed significantly better than chance in 83% of the tests. Using the video camera, subjects scored as follows on simple visual tasks: locate and count objects (77% to 100%), differentiate three objects (63% to 73%), determine the orientation of a capital L (50% to 77%), and differentiate four directions of a moving object (40% to 90%). A subset of tests compared camera settings using multipixels vs single pixels. Using multipixel settings, subjects performed better (17%) or equivalent (83%) in accuracy and better (25%) or equivalent (75%) in reaction time. CONCLUSIONS: Three RP implant subjects used epiretinal prostheses to perform simple visual tasks. Multipixel settings proved slightly more effective than single pixel settings.