NCT04634383 A Phase I Feasibility Study of an Intracortical Visual Prosthesis (ICVP) for People With Blindness
| NCT ID | NCT04634383 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Illinois Institute of Technology |
| Condition | Ocular Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2020-08-20 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5 participants in total. It began in 2020-08-20 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. 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
Contact & Investigator
Philip R Troyk, PhD
PRINCIPAL INVESTIGATOR
Illinois Institute of Technology
Frequently Asked Questions
Who can join the NCT04634383 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 70 Years, studying Ocular Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04634383 currently recruiting?
Yes, NCT04634383 is actively recruiting participants. Contact the research team at ICVP@illinoistech.edu for enrollment information.
Where is the NCT04634383 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT04634383 clinical trial?
NCT04634383 is sponsored by Illinois Institute of Technology. The principal investigator is Philip R Troyk, PhD at Illinois Institute of Technology. The trial plans to enroll 5 participants.