Clinical trial NCT06886737: Home-based Vision Therapy
Official title: Home-based Treatment of Binocular Eye Dysfunction in Veterans With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Convergence Insufficiency
Keywords: Vision, Binocular
Convergence, Ocular
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2025-03-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Vergence Capacity (VR-NPC)
timeFrame: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)
measure: System Usability Scale (SUS)
timeFrame: At completion of active treatment block (six-weeks duration)
measure: Simulator Sickness Questionnaire (SSQ)
timeFrame: At completion of active treatment block (six-weeks duration)
Secondary outcomes:
measure: Accommodation
timeFrame: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)
measure: Dynamic Vergence
timeFrame: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)
measure: Stereoacuity
timeFrame: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)
measure: VR Word Reading: Word Accuracy Score
timeFrame: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)
measure: VR Word Reading: Reading Speed Score
timeFrame: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)
measure: WIAT Word Reading Tests: Word Accuracy Score
timeFrame: At study onset, At completion of Block 2 (six weeks duration)
measure: WIAT Word Reading Test: Word Fluency Score
timeFrame: At study onset, At completion of Block 2 (six weeks duration)
measure: WIAT Oral Reading Fluency and Comprehension Test: Oral Reading Accuracy Score
timeFrame: At study onset, At completion of Block 2 (six weeks duration)
measure: WIAT Oral Reading Fluency and Comprehension Test: Oral Reading Fluency Score
timeFrame: At study onset, At completion of Block 2 (six weeks duration)
measure: Convergence Insufficiency Symptom Survey (CISS)
timeFrame: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center, Cleveland, OH
state: Ohio
Study officials:
affiliation: Louis Stokes VA Medical Center, Cleveland, OH
name: Mark F. Walker, MD
role: PRINCIPAL_INVESTIGATOR
References: