Actively Recruiting
Eye Recovery Automation for Post Injury Dysfunction Using Virtual Reality Vergence Therapy
Led by New Jersey Institute of Technology · Updated on 2026-04-14
100
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
N
New Jersey Institute of Technology
Lead Sponsor
U
U.S. Army Medical Research and Development Command
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a portable virtual reality (VR) system with integrated eye tracking called Virtual Eye Rotation Vision Exercises (VERVE) to deliver automated vergence therapy. This study involves 30 binocularly normal Veterans without traumatic brain injury (BNC) and 50 Veterans with post-traumatic convergence insufficiency (PTCI) after mild traumatic brain injury (mTBI). The goal is to determine the effectiveness of active versus sham VERVE therapy in improving vision function. Participants are randomly assigned to one of four groups: binocularly normal controls receiving either active or sham therapy and PTCI participants receiving either active or sham therapy. The VERVE device uses a VR headset where participants perform specific convergence and divergence eye movements through a game controlled by their eye movements. The sham therapy involves playing the same VR game without changes in eye movement demands, maximizing gameplay without intervention. Participants undergo assessments before and after intervention sessions, including measures of near point of convergence, positive fusional vergence, and objective eye-tracking metrics like peak velocity and response accuracy. Symptom surveys related to brain injury vision, neurobehavioral symptoms, and convergence insufficiency are also completed. These evaluations occur at baseline, after selected intervention sessions, and within one week after completing intervention to monitor changes and safety throughout the study period.
CONDITIONS
Brief Title
Eye Recovery Automation for Post Injury Dysfunction (iRAPID)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 40 years
- For mild traumatic brain injury group: documented mild TBI with alteration or loss of consciousness within specified limits
- Injury occurred between 1 month and 15 years ago
- Glasgow Coma Scale score between 13 and 15, if available
- Post-traumatic amnesia less than 24 hours, if any
- Ongoing post-concussive symptoms with specific symptom scores on Neurobehavioral Symptom Inventory
- Vision-related symptoms with Brain Injury Vision Symptom Survey score of 31 or higher
- Convergence insufficiency symptoms with CISS score of 21 or higher
- Fluent in English
- Stable doses of vision-altering medications for at least 2 months
- Stereopsis of 500 sec arc using Randot Stereo Test
- Exophoria at near 4 prism-diopter or greater than magnitude at distance
- Near point of convergence greater than 5 cm
- Convergence amplitude at near less than 15 prism diopters or Sheard criterion not met
- For control group: aged 18 to 40 years
- CISS score of 20 or lower
- Near point of convergence less than 6 cm
- Positive fusional range greater than 15 prism diopters
- Stereopsis of 500 sec arc using Randot Stereo Test
You will not qualify if you...
- Prior history of neurological diseases other than mild TBI
- History of psychosis
- Current or recent (within 2 years) substance or alcohol dependence
- Recent medical hospitalization within 3 weeks
- Any condition preventing completion of the study protocol
- Appointment of a legal representative
- Ongoing litigation related to traumatic brain injury
- Membership in vulnerable populations such as minors or prisoners
- Previous vergence therapy or orthoptics
- Amblyopia or constant strabismus or history of strabismus surgery
- High refractive errors including myopia ≥ 6.0 PD sphere, hyperopia ≥ 5.0 PD sphere, astigmatism ≥ 4.0 PD, anisometropia > 1.5 PD difference, or prior refractive surgery
- Manifest or latent nystagmus
- Systemic diseases affecting eye accommodation, vergence, or motility such as multiple sclerosis, Graves' disease, myasthenia gravis, diabetes, chemotherapy, or Parkinson's disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 sessions over several weeks
Participants receive virtual reality vergence therapy or sham VR therapy to improve eye movement function after injury.
Multiple sessions, with assessments within 1 week after sessions 4, 8, and 12
Trial Site Locations
Total: 1 location
1
New Mexico VA Health Care System
Albuquerque, New Mexico, United States, 87108
Actively Recruiting
Research Team
C
Chang Yaramothu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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