Recruiting
Phase 1

Virtual-Reality Training

Sponsor:

VA Office of Research and Development

Code:

NCT06886737

Conditions

Convergence Insufficiency

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Virtual-reality convergence training game

Study Details

Brief summary:

Post-concussive vision symptoms affect many Veterans who have experienced traumatic brain injury (TBI). One common issue is trouble with near vision, a problem that may persist long after the acute injury. Double vision or difficulty focusing on close objects can affect reading and depth perception. Poor reading can interfere with academic or work performance, and loss of near focusing can affect jobs that require fine motor tasks like machining and electrical work. Even having trouble using a smartphone can have a substantial impact on both work and social function. Near vision impairment after TBI is not well understood, and treatments are limited. The goal of this project is to investigate novel virtual-reality assessments and training games to improve the near vision diagnosis and home-based rehabilitation. Restoring normal near vision function could have a large impact on the fulfillment of Veterans' educational, career, and overall life goals.

Conditions

Convergence Insufficiency

Study ID

NCT06886737

Start date

Jan 14, 2026

Status verified date

Jan, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • U.S. Military Veteran
  • Place of residence within driving distance of Cleveland, OH
  • Clinical eye exam within 6 months prior to enrollment and since the most recent TBI (if applicable) and the onset of near vision symptoms (if applicable)
  • Best-corrected visual acuity 20/25 or better in each eye
  • Convergence insufficiency (VR-NPC < 32 deg)

Exclusion Criteria:

  • Neurological condition other than TBI that would affect convergence
  • History of strabismus, amblyopia, or other binocular vision issues prior to TBI

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group A

Intervention block followed by non-intervention block

experimental: Group B

Non-intervention block followed by intervention block

Interventions

Virtual-reality convergence training game

The participant plays a custom virtual-reality game that is designed to train convergence.

Primary outcome measure

  • Vergence Capacity (VR-NPC) [ Time Frame: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration) ]
  • System Usability Scale (SUS) [ Time Frame: At completion of active treatment block (six-weeks duration) ]
  • Simulator Sickness Questionnaire (SSQ) [ Time Frame: At completion of active treatment block (six-weeks duration) ]

Central Contacts and Locations

Central contacts

Mark F Walker, MD

(216) 791-3800Mark.Walker5@va.gov

Locations

Louis Stokes VA Medical Center, Cleveland, OH

Recruiting

Cleveland, Ohio, United States, 44106-1702

Contacts

Mark F Walker, MD

(216) 791-3800Mark.Walker5@va.gov

Principal Investigator:

Mark F. Walker, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Keywords

  • Vision, Binocular
  • Convergence, Ocular

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-01-20.