What is the ICVP device studying for people with blindness?

The ICVP device is being studied to see if electrical stimulation of the brain's visual cortex can create artificial vision in people who are blind. Researchers want to understand whether this wireless device can safely produce visual percepts and improve visual experience. The study is sponsored by the Illinois Institute of Technology and focuses on people with severe vision loss.

Who may be eligible for this blindness clinical trial?

Adults aged 19 to 70 with no or very limited light perception in both eyes, who have been blind for at least one year, may be eligible. Participants should have had normal or near-normal vision during early life and be willing to attend study visits. Please review eligibility criteria for more details.

Is there any cost to participate in this blindness clinical trial?

Study-related care, including the implanted device and all trial visits, is provided at no cost. However, personal travel expenses to attend visits may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 19Years - 70Years

All Genders

ID04634383

ICVP - A Phase I Clinical Trial to Determine the Feasibility of a Human Cortical Visual Prosthesis for People With Blindness

Led by Illinois Institute of Technology · Updated on 2026-06-03

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the feasibility of producing artificial vision in people who are blind by using a device called the Intracortical Visual Prosthesis ICVP. This study aims to test the safety of the ICVP system and evaluate whether electrical stimulation of the brains visual processing areas can create visual percepts. The study involves participants with no light perception or very limited vision who have been blind for at least one year and have a history of normal or near-normal vision in early life. The intervention involves implanting wireless floating microelectrode arrays WFMAs into the visual cortex on one side of the brain. These devices deliver wirelessly transmitted electrical stimulation intended to induce artificial vision. Each participant will have multiple WFMA devices implanted. After surgical recovery, participants will undergo weekly testing for one to three years to assess the ability of electrical stimulation to generate visual percepts and evaluate the devices safety and efficacy. Participants will attend regular testing sessions to measure visual perception responses to stimulation and monitor safety outcomes. Researchers will perform assessments from two weeks after surgery through the entire device use period, up to three years. The primary outcome is the safety of the WFMA-based cortical interface, while secondary measures evaluate its effectiveness at producing visual percepts. The study includes video and audio recordings, cognitive and spatial functioning tests, and MRI scans. Participant involvement may last up to three years, with ongoing monitoring throughout the study.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 19Years - 70Years

All Genders

Eligibility Criteria

You may qualify if you...

No light perception or bare light perception in each eye with no expectation of improvement through approved treatments
History of normal or near-normal vision for at least the first 10 years of life
Blindness for at least one year
History of vision or blindness rehabilitation
Willing and able to meet study time demands with transportation help
Agree to audio and video recording as part of the study
Motivated to participate in pioneering science
Support from spouse, family, or friends
High or average cognitive and spatial functioning
Normal structural MRI
English as preferred language
Normal decision-making capacity

You will not qualify if you...

Poor adjustment to blindness or vision loss within the last year
Expectation of vision restoration to pre-blindness level through study participation
History of alcohol or drug dependence
Prior immune response causing orthopedic implant removal
Life expectancy less than five years
Implants preventing MRI screening, pacemaker, or similar devices
History of seizures
Current suicidal thoughts
Poor decision-making capacity
Current or history of severe mental illness
Women who are pregnant or planning pregnancy during the trial
Vision better than Hand Motion (HM) vision
No Light Perception or Light Perception vision with OptoKinetic Nystagmus
No Light Perception vision with pupil constriction
Islands of perceivable vision in visual field testing
Complete media opacity blocking posterior segment visualization
No Light Perception or Light Perception vision since birth
Patients with incomplete development of higher visual pathways including cortical connections

Research Team

Recruitment Director

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