Convergence InsufficiencyiRAPIDNCT06105892
Eye Recovery Automation for Post Injury Dysfunction (iRAPID)
A study testing Virtual Eye Rotation Vision Exercise (VERVE) in people with Convergence Insufficiency and Traumatic Brain Injury, run by New Jersey Institute of Technology at 1 site in United States.
Trial summary
This study will test a portable virtual reality (VR) system with integrated eye tracking called Virtual Eye Rotation Vision Exercises (VERVE). The proposed VERVE platform will deliver vergence therapy in an automated manner. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Convergence Insufficiency, Traumatic Brain Injury, Concussion, Mild
- What is being tested?
- Virtual Eye Rotation Vision Exercise (VERVE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2023to 20 Sep 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- prior history of other neurological diseases, so as to reduce the risk of confounding effects on vision;
- history of psychosis, as there are known visual performance findings associated with psychosis;
- history of current or recent (within two years) substance/alcohol dependence, to reduce confounding effects on visual function
- recent medical hospitalization (within three weeks), to reduce risk of rehospitalization during the study;
- any condition that would prevent the participant from completing the protocol;
- appointment of a legal representative, to avoid coercion of a vulnerable population;
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- any ongoing litigation related to TBI, to prevent interference with legal proceedings;
- membership in an identified vulnerable population, including minors and prisoners, so as to prevent coercion.
- Previous vergence therapy, orthoptics, home-based therapy, etc.
- Amblyopia or constant strabismus or strabismus surgery.
- High refractive error: Myopia ≥ 6.0PD sphere; Hyperopia ≥ 5.0PD sphere; Astigmatism ≥ 4.0PD; Anisometropia >1.5PD difference between eyes; Prior refractive surgery.
- Manifest or latent nystagmus evident clinically.
- Systemic diseases that affect accommodation, vergence, or ocular motility (i.e. multiple sclerosis, Graves' thyroid disease, myasthenia gravis, diabetes, chemotherapy or Parkinson disease).
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
New Mexico VA Health Care System
Albuquerque, New Mexico, 87108
Kelli Ober, kelli.ober@va.gov
Tiana Maple, tiana.maple@va.gov
About this study
Official title: Eye Recovery Automation for Post Injury Dysfunction
This study will test a portable virtual reality (VR) system with integrated eye tracking called Virtual Eye Rotation Vision Exercises (VERVE). The proposed VERVE platform will deliver vergence therapy in an automated manner. This research will involve 30 non-traumatic brain injury (TBI) binocularly normal (BNC) Veterans and 50 post-traumatic convergence insufficiency (PTCI) Veterans who will undergo Active and Sham therapy (equally divided groups) to determine the effectiveness of VERVE vergence therapy.
- Being tested
- Virtual Eye Rotation Vision Exercise (VERVE), Sham VR Therapy
- Keywords
- Virtual Reality, Cross-Sectional, Therapy, Convergence Insufficiency, Traumatic Brain Injury
- Medical subject headings
- Ocular Motility Disorders, Brain Injuries, Traumatic, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Eye Rotation Vision Exercise (VERVE)Device
Also called Virtual Reality Vergence Exercises, Vergency Therapy
VERVE utilizes a virtual reality (VR) headset with integrated eye-tracking where the patient makes specific vergence eye movements by playing a VR game controlled by eye movements. Participants will be making convergence and divergence eye movements as steps and ramps.
Sham VR TherapyDevice
VERVE game without changes in eye movement demands. Maximizing gameplay with no intervention.
| Study group | Role | What they receive |
|---|---|---|
| BNC Active | Experimental | Binocularly normal controls receiving active therapy Receives: Device: Virtual Eye Rotation Vision Exercise (VERVE) |
| BNC Sham | Sham comparator | Binocularly normal controls receiving sham therapy Receives: Device: Sham VR Therapy |
| PTCI Active | Experimental | Post-traumatic Convergence Insufficiency participants receiving active therapy Receives: Device: Virtual Eye Rotation Vision Exercise (VERVE) |
| PTCI Sham | Sham comparator | Post-traumatic Convergence Insufficiency participants receiving sham therapy Receives: Device: Sham VR Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Near Point of Convergence
Normal range is < 6 cm
Measured: Baseline (preintervention), within 1 week after session 4 of intervention, within 1 week after session 8 of intervention, within 1 week after session 12 of intervention, and within 1 week after intervention
Positive Fusional Vergence
Normal range is >15 Prism Diopters
Measured: Baseline (preintervention), within 1 week after session 4 of intervention, within 1 week after session 8 of intervention, within 1 week after session 12 of intervention, and within 1 week after intervention
Objective Eye-Tracking Measures (Peak Velocity)
measured in degress/second
Measured: Baseline (preintervention) and within 1 week after intervention
Objective Eye-Tracking Measures (Response Accuracy)
measured as a percentage of response divided by target amplitude
Measured: Baseline (preintervention) and within 1 week after intervention
Secondary outcomes (3)
Brain Injury Vision Symptom Survey
Normal range is < 31 for adults
Measured: Baseline (preintervention) and within 1 week after intervention
Neurobehavioral Symptom Inventory
Normal range is < 18 for adults
Measured: Baseline (preintervention) and within 1 week after intervention
Convergence Insufficiency Symptom Survey
Normal range is < 21 for adults
Measured: Baseline (preintervention) and within 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start23 Oct 2023
- Primary completion20 Jun 2027 (estimated)
- Study completion20 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Convergence InsufficiencyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each of these participant cohorts (Control and TBI with CI \[PTCI\]) will be randomly halved to generate a total of four cohorts for a semi-crossover study design: 1) BNC Active, 2) BNC Sham \[Placebo\], 3) PTCI Active, and 4) PTCI Sham \[control group\]. PTCI participants in Sham will later undergo active therapy.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Jersey Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command, University of New Mexico, Biomedical Research Institute of New Mexico, New Mexico VA Healthcare System
- Responsible party
- Principal investigator, Chang Yaramothu, New Jersey Institute of Technology
- Investigators
- Chang Yaramothu, PhD, Principal investigator, New Jersey Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105892
- Sponsor's protocol ID
- SQRL001
- Other IDs
- W81XWH22C0146
- Acronym
- iRAPID
- Status last verified
- Apr 2026
- First submitted
- 17 Oct 2023
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified data will be shared on Federal Interagency Traumatic Brain Injury Research Informatics System (FITBIR).
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye Recovery Automation for Post Injury Dysfunction
- ClinicalTrials.gov ID
- NCT06105892
- Acronym / sponsor ID
- iRAPID / SQRL001
- Keywords
- Virtual Reality, Cross-Sectional, Therapy, Convergence Insufficiency, Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- New Jersey Institute of TechnologyUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command, University of New Mexico, Biomedical Research Institute of New Mexico, New Mexico VA Healthcare System
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 20 Jun 2027 (estimated)
- Study completion
- 20 Sep 2027 (estimated)
- First posted
- 30 Oct 2023 (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.
This study will test a portable virtual reality (VR) system with integrated eye tracking called Virtual Eye Rotation Vision Exercises (VERVE). The proposed VERVE platform will deliver vergence therapy in an automated manner. This research will involve 30 non-traumatic brain injury (TBI) binocularly normal (BNC) Veterans and 50 post-traumatic convergence insufficiency (PTCI) Veterans who will undergo Active and Sham therapy (equally divided groups) to determine the effectiveness of VERVE vergence therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Each of these participant cohorts (Control and TBI with CI [PTCI]) will be randomly halved to generate a total of four cohorts for a semi-crossover study design: 1) BNC Active, 2) BNC Sham [Placebo], 3) PTCI Active, and 4) PTCI Sham [control group]. PTCI participants in Sham will later undergo active therapy.
| Arm | Type | Receives |
|---|---|---|
| BNC Active | Experimental | Device: Virtual Eye Rotation Vision Exercise (VERVE)Binocularly normal controls receiving active therapy |
| BNC Sham | Sham comparator | Device: Sham VR TherapyBinocularly normal controls receiving sham therapy |
| PTCI Active | Experimental | Device: Virtual Eye Rotation Vision Exercise (VERVE)Post-traumatic Convergence Insufficiency participants receiving active therapy |
| PTCI Sham | Sham comparator | Device: Sham VR TherapyPost-traumatic Convergence Insufficiency participants receiving sham therapy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- prior history of other neurological diseases, so as to reduce the risk of confounding effects on vision;
- history of psychosis, as there are known visual performance findings associated with psychosis;
- history of current or recent (within two years) substance/alcohol dependence, to reduce confounding effects on visual function
- recent medical hospitalization (within three weeks), to reduce risk of rehospitalization during the study;
- any condition that would prevent the participant from completing the protocol;
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 |
|---|---|---|
| Virtual Eye Rotation Vision Exercise (VERVE)Also: Virtual Reality Vergence Exercises, Vergency TherapyVERVE utilizes a virtual reality (VR) headset with integrated eye-tracking where the patient makes specific vergence eye movements by playing a VR game controlled by eye movements. Participants will be making convergence and divergence eye movements as steps and ramps. | Device | BNC Active, PTCI Active |
| Sham VR TherapyVERVE game without changes in eye movement demands. Maximizing gameplay with no intervention. | Device | BNC Sham, PTCI Sham |
Primary outcome
Near Point of Convergence
Time frame: Baseline (preintervention), within 1 week after session 4 of intervention, within 1 week after session 8 of intervention, within 1 week after session 12 of intervention, and within 1 week after intervention
Normal range is < 6 cm
Positive Fusional Vergence
Time frame: Baseline (preintervention), within 1 week after session 4 of intervention, within 1 week after session 8 of intervention, within 1 week after session 12 of intervention, and within 1 week after intervention
Normal range is >15 Prism Diopters
Objective Eye-Tracking Measures (Peak Velocity)
Time frame: Baseline (preintervention) and within 1 week after intervention
measured in degress/second
Objective Eye-Tracking Measures (Response Accuracy)
Time frame: Baseline (preintervention) and within 1 week after intervention
measured as a percentage of response divided by target amplitude
3 secondary outcomes
Brain Injury Vision Symptom Survey
Time frame: Baseline (preintervention) and within 1 week after intervention
Neurobehavioral Symptom Inventory
Time frame: Baseline (preintervention) and within 1 week after intervention
Convergence Insufficiency Symptom Survey
Time frame: Baseline (preintervention) and within 1 week after intervention
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 14 Apr 2026.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared on Federal Interagency Traumatic Brain Injury Research Informatics System (FITBIR).
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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.
Chang Yaramothu, PhD principal investigator
New Jersey 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 Virtual Eye Rotation Vision Exercise (VERVE) in people with Convergence Insufficiency and Traumatic Brain Injury, run by New Jersey 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 0 inclusion and 13 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 14 Apr 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. Some participants in this study may receive a placebo. 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 Chang Yaramothu, PhD (9736424844, cy53@njit.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Near Point of Convergence (time frame: Baseline (preintervention), within 1 week after session 4 of intervention, within 1 week after session 8 of intervention, within 1 week after session 12 of intervention, and within 1 week after intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2026.