Eye Recovery Automation for Post Injury Dysfunction (iRAPID)

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
New Jersey Institute of Technology
Study ID
NCT06105892
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • 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.
  • Sham VR Therapy — DEVICE
    VERVE game without changes in eye movement demands. Maximizing gameplay with no intervention.

Study Details

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.

Key Dates

Start date
Oct 23, 2023
Status verified
Apr 2026
Primary completion
Jun 20, 2027
Completion
Sep 20, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: BNC Active
    Binocularly normal controls receiving active therapy
  • Sham Comparator: BNC Sham
    Binocularly normal controls receiving sham therapy
  • Experimental: PTCI Active
    Post-traumatic Convergence Insufficiency participants receiving active therapy
  • Sham Comparator: PTCI Sham
    Post-traumatic Convergence Insufficiency participants receiving sham therapy

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New Mexico VA Health Care SystemAlbuquerqueNew Mexico87108
Tiana Maple
[email protected]
Billie C Pack, OD (PRINCIPAL_INVESTIGATOR)

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By research site
New Mexico VA Health Care System· Albuquerque, NM

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