Early Feasibility Clinical Trial of a Visual Cortical Prosthesis

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Project Summary Blindness in the United States is a large and increasing problem. Any significant vision loss is debilitating, but profound blindness is devastating to an individual’s ability to be independent and to perform everyday tasks and activities. Hundreds of thousands of people in the United States suffer from profound blindness, and most of these currently have no hope of vision recovery. Recently, a retinal prosthesis has become available in Europe, U.S., and Canada for people with profound vision loss from Retinitis Pigmentosa, a degenerative retinal disease. This prosthesis, the Argus® II Retinal Prosthesis System, has been approved by the FDA for commercial use in these patients. However, the Argus II System can only help a small subset of people who are profoundly blind. The goal of this project is to conduct a small scale clinical study with the intent of developing the final version of a visual prosthesis to be placed in the visual cortex – the part of the brain that processes vision. It will be based on the successful platform of the Argus II System, but modified for implant in the brain. A cortical prosthesis could help restore visual perception to many more profoundly blind people, including people who have lost their vision due to disease or damage to the eyes, optic nerve, or thalamus. This visual cortical prosthesis, called the Orion, will consist of an array of 60 electrodes that is implanted on the surface of the brain, a receiving antenna, and an electronics case. The implant will communicate wirelessly with the external equipment via a transmitting antenna. Other external components include glasses embedded with a small video camera and a video processing unit that the implanted patient wears on a belt or strap. This project will be to conduct a small early feasibility clinical trial of the device in ten people, to evaluate safety, efficacy, reliability and to conduct psychophysics characterization studies. At the end of this grant period, the cortical prosthesis will be completely developed and positioned for testing in a larger group of human subjects.