Home-based Vision Therapy

VA Office of Research and Development

Status and phase: Enrolling; Phase 1

Conditions: Convergence Insufficiency

Treatments: Other: Virtual-reality convergence training game

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06886737

N5317-R

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Group A

Experimental group

Description:

Intervention block followed by non-intervention block

Treatment:

Other: Virtual-reality convergence training game

Group B

Experimental group

Description:

Non-intervention block followed by intervention block

Treatment:

Other: Virtual-reality convergence training game