Home-based vision therapy for post-concussive near-vision problems
Home-based Treatment of Binocular Eye Dysfunction in Veterans With Traumatic Brain Injury
PHASE1 · VA Office of Research and Development · NCT06886737
We will test a virtual-reality home training game to help Veterans with convergence insufficiency after concussion improve near vision and reduce double vision.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06886737 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional study enrolls U.S. military Veterans with convergence insufficiency to use a virtual-reality convergence training game at home. Participants must have recent clinical eye exams, best-corrected visual acuity of 20/25 or better, and live within driving distance of Cleveland, Ohio. The program combines novel VR-based diagnostic tasks with game-like training exercises aimed at improving near point convergence and binocular coordination. Study staff at the VA will perform baseline and follow-up measurements to track changes in near vision function.
Who should consider this trial
Good fit: U.S. military Veterans with convergence insufficiency after TBI who have good corrected vision (20/25 or better), a recent eye exam, and live within driving distance of Cleveland, Ohio.
Not a fit: Patients with prior binocular vision problems such as pre-existing strabismus or amblyopia, other neurological conditions affecting convergence, or worse than 20/25 acuity are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the VR home-training could restore near vision function, reduce double vision, and improve reading, work, and daily activities for affected Veterans.
How similar studies have performed: Clinic-based vision therapy has shown benefit for convergence insufficiency in some studies, but home-based virtual-reality approaches are novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * U.S. Military Veteran * Place of residence within driving distance of Cleveland, OH * Clinical eye exam within 6 months prior to enrollment and since the most recent TBI (if applicable) and the onset of near vision symptoms (if applicable) * Best-corrected visual acuity 20/25 or better in each eye * Convergence insufficiency (VR-NPC \< 32 deg) Exclusion Criteria: * Neurological condition other than TBI that would affect convergence * History of strabismus, amblyopia, or other binocular vision issues prior to TBI
Where this trial is running
Cleveland, Ohio
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Mark F. Walker, MD — Louis Stokes VA Medical Center, Cleveland, OH
- Study coordinator: Mark F Walker, MD
- Email: Mark.Walker5@va.gov
- Phone: (216) 791-3800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Convergence Insufficiency, Vision, Binocular, Convergence, Ocular