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Official title A Phase I Feasibility Study of an Intracortical Visual Prosthesis (ICVP) for People With Blindness
ClinicalTrials.gov ID: NCT04634383
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 70
You may be able to join if
- No light perception or bare light perception, in each eye in accordance with relevant International Classification of Diseases, Tenth Revision...
- 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.
You likely can't join 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.
See the full eligibility 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...
- 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.
- 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 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.