Home-based Vision Therapy

NCT06886737 | Recruiting Phase 1

• 1 other identifier: N5317-R
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

Vision, Binocular; Convergence, Ocular

Outcome Measures

Primary Outcomes (3)

• Vergence Capacity (VR-NPC)

  The near point of convergence (angle of maximum ocular convergence) will be measured using a custom virtual-reality application.

  At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)

• System Usability Scale (SUS)

  This is a standardized questionnaire to assess how easy a new technology is to use.

  At completion of active treatment block (six-weeks duration)

• Simulator Sickness Questionnaire (SSQ)

  This is a standardized questionnaire to test the player's tolerance of the virtual-reality experience.

  At completion of active treatment block (six-weeks duration)

Secondary Outcomes (10)

• Accommodation

  At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)

• Dynamic Vergence

  At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)

• Stereoacuity

  At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)

• VR Word Reading: Word Accuracy Score

  At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)

• VR Word Reading: Reading Speed Score

  At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)

Study Arms (2)

Group A

EXPERIMENTAL

Intervention block followed by non-intervention block

Other: Virtual-reality convergence training game

Group B

EXPERIMENTAL

Non-intervention block followed by intervention block

Other: Virtual-reality convergence training game

Interventions

Virtual-reality convergence training game OTHER

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

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

RECRUITING

MeSH Terms

Conditions

Ocular Motility Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cranial Nerve Diseases; Eye Diseases

Study Officials

• Mark F. Walker, MD

  Louis Stokes VA Medical Center, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark F Walker, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants perform convergence exercises at home in the form of a custom virtual-reality game. The trial is divided into two 6-week blocks, one for active treatment and one for no treatment. Participants will be randomized into the treatment-first or treatment-second arm.

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 20, 2025
• Study Start: January 14, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)