Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
All Genders
Healthy Volunteers
NCT06105892

Eye Recovery Automation for Post Injury Dysfunction (iRAPID)

Led by New Jersey Institute of Technology · Updated on 2026-04-14

100

Participants Needed

1

Research Sites

204 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

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.

CONDITIONS

Official Title

Eye Recovery Automation for Post Injury Dysfunction (iRAPID)

Who Can Participate

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 18 and 40 years
  • For mild traumatic brain injury (mTBI) group: diagnosed with mTBI per VA/DoD criteria with alteration of consciousness less than 24 hours or loss of consciousness less than 30 minutes
  • Injury occurred between 1 month and 15 years ago
  • Glasgow coma scale score between 13 and 15 upon emergency department admission, if available
  • Post-traumatic amnesia less than 24 hours, if any
  • Ongoing post-concussive symptoms with Neurobehavioral Symptom Inventory score 18 or higher or vision problem score 2 or higher
  • Ongoing vision-related symptoms with Brain Injury Vision Symptom Survey score 31 or higher
  • Post-traumatic convergence insufficiency with convergence insufficiency symptom survey score 21 or higher
  • Fluent in English
  • Stable doses of vision-altering medications for at least 2 months
  • Stereopsis of 500 seconds of arc using Randot Stereo Test
  • Exophoria at near of 4 prism diopters or more, or greater than magnitude at distance
  • Near point of convergence greater than 5 cm
  • Convergence amplitude at near less than 15 prism diopters break or Sheard criterion not met
  • For control group: aged between 18 and 40 years
  • Convergence insufficiency symptom survey score 20 or lower
  • Near point of convergence less than 6 cm
  • Positive fusional range greater than 15 prism diopters
  • Stereopsis of 500 seconds of arc using Randot Stereo Test
Not Eligible

You will not qualify if you...

  • Prior history of neurological diseases other than mTBI
  • 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, orthoptics, or home-based therapy
  • Amblyopia, constant strabismus, or strabismus surgery
  • High refractive error: myopia 6.0 prism diopters or more; hyperopia 5.0 prism diopters or more; astigmatism 4.0 prism diopters or more; anisometropia greater than 1.5 prism diopters difference between eyes; prior refractive surgery
  • Manifest or latent nystagmus
  • Systemic diseases affecting eye accommodation, vergence, or motility (e.g., multiple sclerosis, Graves' disease, myasthenia gravis, diabetes, chemotherapy effects, Parkinson disease)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

New Mexico VA Health Care System

Albuquerque, New Mexico, United States, 87108

Actively Recruiting

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Research Team

C

Chang Yaramothu, PhD

CONTACT

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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