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NCT Number: NCT06105892

Eye Recovery Automation for Post Injury Dysfunction (iRAPID)

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Mexico VA Health Care System

Albuquerque, New Mexico, 87108, United States

Location status: Recruiting

Location contact

Billie C Pack, OD

PRINCIPAL_INVESTIGATOR

Kelli Ober

CONTACT

[email protected]

Tiana Maple

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Virtual Eye Rotation Vision Exercise (VERVE)

Device

VERVE utilizes a virtual reality (VR) headset with integrated eye-tracking where the patient makes specific vergence eye movements by playing a VR game controlled by eye movements. Participants will be making convergence and divergence eye movements as steps and ramps.

Other names: Virtual Reality Vergence Exercises, Vergency Therapy

Sham VR Therapy

Device

VERVE game without changes in eye movement demands. Maximizing gameplay with no intervention.

Primary outcomes

  1. Near Point of Convergence

    Time frame: Baseline (preintervention), within 1 week after session 4 of intervention, within 1 week after session 8 of intervention, within 1 week after session 12 of intervention, and within 1 week after intervention

    Normal range is < 6 cm

  2. Positive Fusional Vergence

    Time frame: Baseline (preintervention), within 1 week after session 4 of intervention, within 1 week after session 8 of intervention, within 1 week after session 12 of intervention, and within 1 week after intervention

    Normal range is >15 Prism Diopters

  3. Objective Eye-Tracking Measures (Peak Velocity)

    Time frame: Baseline (preintervention) and within 1 week after intervention

    measured in degress/second

  4. Objective Eye-Tracking Measures (Response Accuracy)

    Time frame: Baseline (preintervention) and within 1 week after intervention

    measured as a percentage of response divided by target amplitude

Secondary outcomes

  1. Brain Injury Vision Symptom Survey

    Time frame: Baseline (preintervention) and within 1 week after intervention

    Normal range is < 31 for adults

  2. Neurobehavioral Symptom Inventory

    Time frame: Baseline (preintervention) and within 1 week after intervention

    Normal range is < 18 for adults

  3. Convergence Insufficiency Symptom Survey

    Time frame: Baseline (preintervention) and within 1 week after intervention

    Normal range is < 21 for adults

Study contacts

Contact information is provided by the study sponsor or research team.

Chang Yaramothu, PhD

CONTACT

[email protected]

9736424844

Sponsors and collaborators

Lead sponsor

New Jersey Institute of Technology

Other

Collaborators

  • Biomedical Research Institute of New Mexico
  • New Mexico VA Healthcare System
  • U.S. Army Medical Research and Development Command
  • University of New Mexico

Registry information

Official study title

Eye Recovery Automation for Post Injury Dysfunction

Acronym: iRAPID

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 30, 2023
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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