A Phase I Feasibility Study of an Intracortical Visual Prosthesis (ICVP) for People With Blindness

Inclusion Criteria:

• No light perception or bare light perception, in each eye in accordance with relevantInternational Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes, where the physician has no expectation of improvement throughcurrently approved treatments.
• History of normal or near-normal vision, with or without refractive correction, duringat 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-screeningconsent.
• 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.

Exclusion Criteria:

• Poor adjustment to blindness, or vision loss within the last year.
• Expectation of vision restoration to pre-blindness level through trial participation.
• History of alcohol or drug dependence.
• Evidence of prior immune response to an orthopedic implant which caused the implant tobe explanted
• A disease prognosis of living less than five years.
• An implant which would prevent screening using MRI, or a pacemaker, or similarimplant.
• A history of seizures.
• Current suicidal ideation.
• Poor decision-making capacity.
• Current diagnosis or history of severe mental illness.
• Women who are pregnant or plan on becoming pregnant in the duration of the trial.
• Hand Motion (HM) vision or better vision,
• No Light Perception (NLP) or Light Perception (LP) vision with present OptoKineticNystagmus (OKN)
• NLP vision with pupil constriction
• Patients with Islands of perceivable vision in Goldmann Visual Field orConfrontational visual Field will also be excluded from the study.
• Patients with Complete media opacity (complete cornea opacity, very dense cataract)that does not allow visualization of the posterior segment to determine the cause ofblindness will be excluded from the study. Only patients with NLP and LP visionwithout OKN will be included in the study.
• Patients with NLP or LP vision since birth will also be excluded from the study, asthey may not have fully developed higher visual pathways, including corticalconnections