Eye Recovery Automation for Post Injury Dysfunction (iRAPID)
New Jersey Institute of Technology · with U.S. Army Medical Research and Development Command, University of New Mexico · NCT06105892
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–40 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 100
- US sites recruiting
- 1
- Study start
- October 23, 2023
- Record last updated
- April 14, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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 studied: Virtual Eye Rotation Vision Exercise (VERVE); Sham VR Therapy
Conditions: Convergence Insufficiency; Traumatic Brain Injury; Concussion, Mild
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Mild Traumatic Brain Injury (mTBI) Cohort Inclusion Criteria:
- are aged 18 - 40;
- have suffered a mTBI according to VA/Department of Defense (DoD) criteria with documented evidence of alteration of consciousness (AOC) \< 24 hours or loss of consciousness (LOC) less than 30 minutes;
- were injured between 1 month and 15 years ago;
- received a Glasgow coma scale (GCS) score of between 13 and 15 upon emergency department (ED) admission, if available;
- experienced less than 24 hours of post-traumatic amnesia (PTA), if any;
- have ongoing post-concussive symptoms as evidenced by a score of 18 or greater or a score of 2 or greater on question 6 (vision problems, blurring, trouble seeing) on the Neurobehavioral Symptom Inventory (NSI);
- have ongoing vision-related symptoms as evidenced by a score of 31 or higher on the Brain Injury Vision Symptom Survey (BIVSS);
- have PTCI as evidenced by obtaining a score of 21 or higher on the convergence insufficiency symptom survey (CISS), a specific measure of convergence insufficiency;
- are fluent in English; and
- have been on stable doses of any vision-altering medications for the past 2 months.
- Stereopsis of 500 sec arc using Randot Stereo Test.
- Exophoria at near 4 prism-diopter (PD) or greater than magnitude at distance
- Near point of convergence (NPC) > 5 cm
- Convergence amplitude at near \< 15PD break or the Sheard criterion not met
Control Inclusion Criteria
- are aged 18 - 40;
- CISS score of 20 or lower;
- near point of convergence (NPC) \< 6cm; and
- positive fusional range >15 prism diopters.
- Stereopsis of 500 sec arc using Randot Stereo Test.
Exclusion Criteria
- 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;
- 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).
Recruiting US locations
New Mexico VA Health Care System
Albuquerque, NM 87108
Site contact: Kelli Ober · kelli.ober@va.gov
Study contacts (from the official record)
- Chang Yaramothu, PhD · 9736424844 · cy53@njit.edu
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