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

Recruiting now · Not applicable

Conditions studied: Ocular Injury, Optic Nerve Diseases, Photoreceptor Degeneration, Blindness,Acquired

In brief

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.

Key facts

Study ID

NCT04634383

Run by

Illinois Institute of Technology

People needed

5

Starts

2020-08-20

Expected to finish

2027-06-30

Last updated by the study team

2026-06-03

Who can join

Age: 19 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Illinois Tech — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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