ICVP - A Phase I Clinical Trial to Determine the Feasibility of a Human Cortical Visual Prosthesis for People With Blindness
The purpose of this study is to determine the feasibility of producing artificial vision in persons with blindness. Study participants will have wireless electrical stimulators implanted into the cortical vision processing areas of their brains. The ability of the participants to perceive artificial vision in response to electrical stimulation will be assessed.
• No light perception or bare light perception, in each eye in accordance with relevant International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes, where the physician has no expectation of improvement through currently approved treatments.
• History of normal or near-normal vision, with or without refractive correction, during at least the first 10 years of life.
• Adjusted to blindness for at least one year.
• History of vision or blindness rehabilitation.
• Willing and able to meet the time demands of the study with transportation assistance.
• Willing to agree to audio and video recording, as specified in the pre-screening consent.
• Motivated by altruism, willingness to participate in pioneering science.
• Demonstrated support from spouse, family and/or friends.
• High or average cognitive and spatial functioning.
• Normal structural MRI.
• English as preferred language.
• Normal decision-making capacity.