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

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 to be explanted
• •A disease prognosis of living less than five years.
• •An implant which would prevent screening using MRI, or a pacemaker, or similar implant.
• •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 OptoKinetic Nystagmus (OKN)
• •NLP vision with pupil constriction
• •Patients with Islands of perceivable vision in Goldmann Visual Field or Confrontational 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 of blindness will be excluded from the study. Only patients with NLP and LP vision without OKN will be included in the study.
• •Patients with NLP or LP vision since birth will also be excluded from the study, as they may not have fully developed higher visual pathways, including cortical connections