RecruitingNCT04634383ICVPUpdated Jun 3, 2026

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

An interventional study of WFMA - wireless floating microelectrode array in Ocular Injury, Optic Nerve Diseases and Photoreceptor Degeneration, sponsored by Illinois Institute of Technology. Recruiting at 1 site in United States. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by Illinois Institute of Technology · Not applicable, Interventional, and Device feasibility

From the registry’s dates

Started Aug 2020; still recruiting 6 years 2 months later.

Phase: Not applicable
Study type: Interventional
Enrollment: 5
Allocation: Not applicable
Ages: 19 Years to 70 Years
Sex: All

Study 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.

Read the detailed description

The objective of this study is to test the safety of the ICVP system and the feasibility of eliciting visual percepts in response to electrical stimulation in persons with blindness. The electrical stimulation is provided by wireless floating microelectrode arrays (WFMAs) that are part of the ICVP system. The WFMAs are implanted in the visual cortex. Five participants will take part in the study and each participant will have multiple WFMA devices implanted in their visual cortex on one side of the brain. After recovery from surgery, participants will begin a series of tests to assess the ability of electrical stimulation to induce visual percepts and how these percepts may provide some measure of artificial vision. Weekly participant testing will occur over a period of one to three years.

Conditions studied

Ocular Injury
Optic Nerve Diseases
Photoreceptor Degeneration
Blindness,Acquired

Browse trials for

Keywords

Blindness
Visual Prosthesis
Electrical Stimulation

In context

Eye Injuries

26 studies on the registry are indexed under Eye Injuries; 2 are open to participants now.

This study's planned enrollment of 5 is below the median of 42 across 11 interventional studies indexed under Eye Injuries.

Browse Eye Injuries studies →

Lead sponsor

Illinois Institute of Technology is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Phase: Not applicable
Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 5 participants (estimated)

Study 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.
Device: WFMA - wireless floating microelectrode array

Interventions

DeviceWFMA - wireless floating microelectrode array
Wirelessly transmitted patterns of electrical stimulation will be delivered to the visual cortex of study participants to generate visual percepts.
Also known as: ICVP System, ICVP, Intracortical Visual Prosthesis

What researchers measure

Primary outcomes

To test the safety of the WFMA-based cortical interface.
Safety is defined as the number of adverse events occurring over the study period due to surgical complications or use of the WFMA device.
Time frame: From two-weeks post-op to end of device use, up to 3 years.

Secondary outcomes

To test the efficacy of the WFMA-based cortical interface
Efficacy is defined as establishing a chronic intracortical interface for which the ability to elicit visual percepts in response to electrical stimulation can be demonstrated with stimulus intensities of 16 nanocoulombs per phase or less.
Time frame: From four-weeks post-op to end of device use, up to 3 years.

Study locations

1 of 1 sites recruiting

Illinois Tech
Chicago, Illinois 60616, United States
Recruiting
- Philip Troyk Principal Investigator, PhD · Contact · ICVP@illinoistech.edu · 312-567-5304
Recruiting

References and documents

Publications

Bak M, Girvin JP, Hambrecht FT, Kufta CV, Loeb GE, Schmidt EM. Visual sensations produced by intracortical microstimulation of the human occipital cortex. Med Biol Eng Comput. 1990 May;28(3):257-9. doi: 10.1007/BF02442682. No abstract available. PubMed 2377008 ↗
Schmidt EM, Bak MJ, Hambrecht FT, Kufta CV, O'Rourke DK, Vallabhanath P. Feasibility of a visual prosthesis for the blind based on intracortical microstimulation of the visual cortex. Brain. 1996 Apr;119 ( Pt 2):507-22. doi: 10.1093/brain/119.2.507. PubMed 8800945 ↗
Stephan K, Troyk PR, Dagnelie G, Cogan S, Barry MP, Grant P, Lane F, Szlyk JP, McNulty M, van Drongelen W, Pham TH, Stipp KL, Royster M, Towle VL. The Role of Scalp EEG Recordings During Cortical Visual Prosthesis Testing. Artif Organs. 2025 Sep;49(9):1417-1428. doi: 10.1111/aor.15023. Epub 2025 May 27. PubMed 40421717 ↗

Individual participant data

Plan to share: Yes — We may electively share de-identified study data with collaborators

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Duration of the study

Access criteria: Data required by study collaborators to perform analysis of safety and efficacy of the ICVP system.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04634383
Lead sponsor: Illinois Institute of Technology
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS), Rush University Medical Center, The Chicago Lighthouse, The University of Texas at Dallas, University of Chicago, Johns Hopkins University
Responsible party: Sponsor
First posted: Nov 18, 2020
Start date: Aug 20, 2020
Primary completion: Jun 30, 2027 (estimated)
Completion: Jun 30, 2027 (estimated)
Last update: Jun 3, 2026

Study contacts

Recruitment Director

Contact

ICVP@illinoistech.edu

312-567-5304

Philip R Troyk, PhD

principal investigator · Illinois Institute of Technology

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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