Feasibility Study of an Intracortical Visual Prosthesis (ICVP) for Blindness

This study is testing a new device called the wireless floating microelectrode array (WFMA) to see if it can create artificial vision for people who are blind. The WFMA is a small electrical stimulator that would be placed in the part of your brain that processes vision. The main goal is to check how safe the WFMA is. You might be able to join if you are 19 to 70 years old and have no light perception or only bare light perception in both eyes, with no expectation of improvement from other treatments. The study aims to see if participants can perceive artificial vision in response to the electrical stimulation. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 5 participants. Each participant will have multiple WFMA devices implanted in one side of their brain.
What's involved
You would have surgery to implant the WFMA devices. After recovering, you would have weekly testing sessions over a period of one to three years to assess your ability to perceive artificial vision.
Compensation
Not stated in the trial record.
Follow-up
The safety of the device will be measured from two weeks after surgery until the end of device use, for up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04634383

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

Recruiting
NAAges 19–70InterventionalDevice feasibility
Illinois Institute of Technology
~5 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:WFMA - wireless floating microelectrode array

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To test the safety of the WFMA-based cortical interface.
Measured over From two-weeks post-op to end of device use, up to 3 years.
Ocular Injury
Optic Nerve Diseases
Photoreceptor Degeneration
Blindness,Acquired

NCT04634383

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Illinois Tech

    Chicago, Illinoisstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Philip R Troyk, PhD · PRINCIPAL_INVESTIGATOR · Illinois Institute of Technology

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Eligibility criteria

Inclusion

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

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
  • To test the safety of the WFMA-based cortical interface.From two-weeks post-op to end of device use, up to 3 years.

    Safety is defined as the number of adverse events occurring over the study period due to surgical complications or use of the WFMA device.