Home-based Vision Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-14

Study Completion Date

2028-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Convergence Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Intervention block followed by non-intervention block

Group Type EXPERIMENTAL

Virtual-reality convergence training game

Intervention Type OTHER

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

Group B

Non-intervention block followed by intervention block

Group Type EXPERIMENTAL

Virtual-reality convergence training game

Intervention Type OTHER

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

Interventions

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Virtual-reality convergence training game

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes