Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06886737

Home-based Vision Therapy

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Convergence Insufficiency Central Nervous System Diseases Cranial Nerve Diseases Eye Diseases Nervous System Diseases Ocular Motility Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

Location status: Recruiting

Location contact

Mark F Walker, MD

CONTACT

[email protected]

(216) 791-3800 ext. 820 5225

Mark F. Walker, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Virtual-reality convergence training game

Other

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

Primary outcomes

  1. 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)

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

  2. System Usability Scale (SUS)

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

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

  3. Simulator Sickness Questionnaire (SSQ)

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

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

Secondary outcomes

  1. Accommodation

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

    Ocular accommodation (focus of the intraocular lens for near viewing) will be measured using the minus-lens method.

  2. Dynamic Vergence

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

    The accuracy and speed of fixation steps between virtual near and far targets is assessed.

  3. Stereoacuity

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

    Stereovision is assessed in virtual reality. Stereoacuity threshold is determined from a curve fit to the response data.

  4. VR Word Reading: Word Accuracy Score

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

    The accuracy and speed of word reading is assessed in response to lists of words presented to the participant in virtual reality. The Word Accuracy Score is the number of words read correctly minus errors.

  5. VR Word Reading: Reading Speed Score

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

    The accuracy and speed of word reading is assessed in response to lists of words presented to the participant in virtual reality. The Reading Speed Score is the Word Accuracy Score divided by total reading time.

  6. WIAT Word Reading Tests: Word Accuracy Score

    Time frame: At study onset, At completion of Block 2 (six weeks duration)

    Participants read lists of words and nonsense words. The number of words read correctly is the accuracy score. Raw score will be converted to a standardized score (mean=100, S.D.=15) using normative data.

  7. WIAT Word Reading Test: Word Fluency Score

    Time frame: At study onset, At completion of Block 2 (six weeks duration)

    Participant reads lists of words and nonsense words. The number of words read correctly within 30 seconds is the fluency score. Raw score will be converted to a standardized score (mean=100, S.D.=15) using normative data.

  8. WIAT Oral Reading Fluency and Comprehension Test: Oral Reading Accuracy Score

    Time frame: At study onset, At completion of Block 2 (six weeks duration)

    Participant reads two passages aloud. The Oral Reading Accuracy Score is the number of words read minus errors (mispronunciations or additions). Raw score will be converted to a standardized score (mean=100, S.D.=15) using normative data.

  9. WIAT Oral Reading Fluency and Comprehension Test: Oral Reading Fluency Score

    Time frame: At study onset, At completion of Block 2 (six weeks duration)

    Participant reads two passages aloud. The Oral Reading Fluency Score is the Oral Reading Accuracy Score (Outcome #9) divided by the time needed to complete reading of the passage. Raw score will be converted to a standardized score (mean=100, S.D.=15) using normative data.

  10. Convergence Insufficiency Symptom Survey (CISS)

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

    This is a standardized questionnaire to assess symptoms related to near vision.

Study contacts

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

Mark F Walker, MD

CONTACT

[email protected]

(216) 791-3800 ext. 820 5225

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Home-based Treatment of Binocular Eye Dysfunction in Veterans With Traumatic Brain Injury

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 20, 2025
Registry last updated
Jan 20, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.