Ocular InjuryICVPNCT04634383
A Phase I Feasibility Study of an Intracortical Visual Prosthesis (ICVP) for People With Blindness
A study testing WFMA - wireless floating microelectrode array in people with Ocular Injury and Optic Nerve Diseases, run by Illinois Institute of Technology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Ocular Injury, Optic Nerve Diseases, Photoreceptor Degeneration
- What is being tested?
- WFMA - wireless floating microelectrode array
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2020to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Illinois Tech
Chicago, Illinois, 60616
Philip Troyk Principal Investigator, PhD, 312-567-5304, ICVP@illinoistech.edu
About this study
Official title: ICVP - A Phase I Clinical Trial to Determine the Feasibility of a Human Cortical Visual Prosthesis for People With Blindness
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.
- Being tested
- WFMA - wireless floating microelectrode array
- Keywords
- Blindness, Visual Prosthesis, Electrical Stimulation
- Medical subject headings
- Eye Injuries, Optic Nerve Diseases, Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WFMA - wireless floating microelectrode arrayDevice
Also called ICVP System, ICVP, Intracortical Visual Prosthesis
Wirelessly transmitted patterns of electrical stimulation will be delivered to the visual cortex of study participants to generate visual percepts.
| Study group | Role | What they receive |
|---|---|---|
| WFMA Cortical Visual Prosthesis Single-arm Study | Experimental | The WFMA is an electronic device that is implanted in the cortical vision processing regions of the brain to produce artificial vision. Receives: Device: WFMA - wireless floating microelectrode array |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From two-weeks post-op to end of device use, up to 3 years.
Secondary outcomes (1)
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.
Measured: From four-weeks post-op to end of device use, up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start20 Aug 2020
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ocular InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Eligible participants for the study will be persons with blindness who meet the listed inclusion criteria. Individuals having any of the listed exclusion criteria will not be eligible to participate in the study. Enrolled participants will receive electrical stimulation devices implanted in the cortical region of their brain that is involved in vision processing. A maximum of five participants will be implanted. Written Informed Consent will be obtained from all participants before they are enrolled in the study.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Illinois Institute of Technology
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Philip R Troyk, PhD, Principal investigator, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634383
- Sponsor's protocol ID
- ICVP0001
- Other IDs
- UH3NS095557
- Acronym
- ICVP
- Status last verified
- Jun 2026
- First submitted
- 12 Oct 2020
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: We may electively share de-identified study data with collaborators
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 2377008Schmidt 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 8800945Stephan 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICVP - A Phase I Clinical Trial to Determine the Feasibility of a Human Cortical Visual Prosthesis for People With Blindness
- ClinicalTrials.gov ID
- NCT04634383
- Acronym / sponsor ID
- ICVP / ICVP0001
- Keywords
- Blindness, Visual Prosthesis, Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Illinois Institute of TechnologyUniversity, hospital or other
- 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
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Eligible participants for the study will be persons with blindness who meet the listed inclusion criteria. Individuals having any of the listed exclusion criteria will not be eligible to participate in the study. Enrolled participants will receive electrical stimulation devices implanted in the cortical region of their brain that is involved in vision processing. A maximum of five participants will be implanted. Written Informed Consent will be obtained from all participants before they are enrolled in the study.
| Arm | Type | Receives |
|---|---|---|
| WFMA Cortical Visual Prosthesis Single-arm Study | Experimental | Device: WFMA - wireless floating microelectrode arrayThe WFMA is an electronic device that is implanted in the cortical vision processing regions of the brain to produce artificial vision. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WFMA - wireless floating microelectrode arrayAlso: ICVP System, ICVP, Intracortical Visual ProsthesisWirelessly transmitted patterns of electrical stimulation will be delivered to the visual cortex of study participants to generate visual percepts. | Device | WFMA Cortical Visual Prosthesis Single-arm Study |
Primary outcome
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.
Safety is defined as the number of adverse events occurring over the study period due to surgical complications or use of the WFMA device.
1 secondary outcome
To test the efficacy of the WFMA-based cortical interface
Time frame: From four-weeks post-op to end of device use, up to 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Background: PubMed 2377008Bak 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.
- Background: PubMed 8800945Schmidt 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.
- Derived from this study: PubMed 40421717Stephan 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.
- Individual participant dataSharing planned: Yes. We may electively share de-identified study data with collaborators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philip R Troyk, PhD principal investigator
Illinois Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WFMA - wireless floating microelectrode array in people with Ocular Injury and Optic Nerve Diseases, run by Illinois Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Recruitment Director (312-567-5304, ICVP@illinoistech.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04634383, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.