NCT06105892 Eye Recovery Automation for Post Injury Dysfunction (iRAPID)
| NCT ID | NCT06105892 |
| Status | Recruiting |
| Phase | — |
| Sponsor | New Jersey Institute of Technology |
| Condition | Convergence Insufficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-10-23 |
| Primary Completion | 2027-06-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-10-23 with a primary completion date of 2027-06-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Mild Traumatic Brain Injury (mTBI) Cohort Inclusion Criteria: 1. are aged 18 - 40; 2. 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; 3. were injured between 1 month and 15 years ago; 4. received a Glasgow coma scale (GCS) score of between 13 and 15 upon emergency department (ED) admission, if available; 5. experienced less than 24 hours of post-traumatic amnesia (PTA), if any; 6. 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); 7. have ongoing vision-related symptoms as evidenced by a score of 31 or higher on the Brain Injury Vision Symptom Survey (BIVSS); 8. 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; 9. are fluent in English; and 10. have been on stable doses of any vision-altering medications for the past 2 months. 11. Stereopsis of 500 sec arc using Randot Stereo Test. 12. Exophoria at near 4 prism-diopter (PD) or greater than magnitude at distance 13. Near point of convergence (NPC) \> 5 cm 14. Convergence amplitude at near \< 15PD break or the Sheard criterion not met Control Inclusion Criteria: 1. are aged 18 - 40; 2. CISS score of 20 or lower; 3. near point of convergence (NPC) \< 6cm; and 4. positive fusional range \>15 prism diopters. 5. Stereopsis of 500 sec arc using Randot Stereo Test. Exclusion Criteria: 1. prior history of other neurological diseases, so as to reduce the risk of confounding effects on vision; 2. history of psychosis, as there are known visual performance findings associated with psychosis; 3. history of current or recent (within two years) substance/alcohol dependence, to reduce confounding effects on visual function 4. recent medical hospitalization (within three weeks), to reduce risk of rehospitalization during the study; 5. any condition that would prevent the participant from completing the protocol; 6. appointment of a legal representative, to avoid coercion of a vulnerable population; 7. any ongoing litigation related to TBI, to prevent interference with legal proceedings; 8. membership in an identified vulnerable population, including minors and prisoners, so as to prevent coercion. 9. Previous vergence therapy, orthoptics, home-based therapy, etc. 10. Amblyopia or constant strabismus or strabismus surgery. 11. High refractive error: Myopia ≥ 6.0PD sphere; Hyperopia ≥ 5.0PD sphere; Astigmatism ≥ 4.0PD; Anisometropia \>1.5PD difference between eyes; Prior refractive surgery. 12. Manifest or latent nystagmus evident clinically. 13. Systemic diseases that affect accommodation, vergence, or ocular motility (i.e. multiple sclerosis, Graves' thyroid disease, myasthenia gravis, diabetes, chemotherapy or Parkinson disease).
Contact & Investigator
Chang Yaramothu, PhD
PRINCIPAL INVESTIGATOR
New Jersey Institute of Technology
Frequently Asked Questions
Who can join the NCT06105892 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Convergence Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06105892 currently recruiting?
Yes, NCT06105892 is actively recruiting participants. Contact the research team at cy53@njit.edu for enrollment information.
Where is the NCT06105892 trial being conducted?
This trial is being conducted at Albuquerque, United States.
Who is sponsoring the NCT06105892 clinical trial?
NCT06105892 is sponsored by New Jersey Institute of Technology. The principal investigator is Chang Yaramothu, PhD at New Jersey Institute of Technology. The trial plans to enroll 100 participants.