Recruiting

Intracortical Visual Prosthesis

Sponsor:

Illinois Institute of Technology

Code:

NCT04634383

Conditions

Ocular Injury

Optic Nerve Diseases

Photoreceptor Degeneration

Blindness,Acquired

Eligibility Criteria

Sex: All

Age: 19 - 70

Healthy Volunteers: Not accepted

Interventions

WFMA - wireless floating microelectrode array

Study Details

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.

Conditions

Ocular Injury

Optic Nerve Diseases

Photoreceptor Degeneration

Blindness,Acquired

Study ID

NCT04634383

Start date

Aug 20, 2020

Status verified date

Jun, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: WFMA Cortical Visual Prosthesis Single-arm Study

The WFMA is an electronic device that is implanted in the cortical vision processing regions of the brain to produce artificial vision.

Interventions

WFMA - wireless floating microelectrode array

Wirelessly transmitted patterns of electrical stimulation will be delivered to the visual cortex of study participants to generate visual percepts.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Recruitment Director

312-567-5304ICVP@illinoistech.edu

Locations

Illinois Tech

Recruiting

Chicago, Illinois, United States, 60616

Contacts

Philip Troyk Principal Investigator, PhD

312-567-5304ICVP@illinoistech.edu

More Information

Sponsor

Illinois Institute of Technology

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Keywords

  • Blindness
  • Visual Prosthesis
  • Electrical Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Illinois Institute of Technology on 2026-06-03.