Effectiveness of Virtual Reality 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

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-14

Study Completion Date

2024-09-30

Brief Summary

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The purpose of this research study is to see how well the treatment of a participant's eye coordination and/or focusing problems improves eye muscle responses and symptoms of eyestrain. We will use an entertainment device called a virtual reality headset to play a custom-designed video game to find out how well the treatment of binocular vision improves a participant's coordination and/or focusing problem. The virtual reality headset uses eye-trackers to monitor progress in a totally objective manner. Objective testing allows the doctor to determine the results without relying on a participant's ability to answer questions or respond verbally in any way. We will compare the results of a participant before and after playing the video game.

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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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Examiner (Outcomes Assessor) will be masked by pooling participants from another study.

Study Groups

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Active Virtual Reality-Based Vision Therapy

Virtual reality vision therapy where participants will be playing a custom-designed video game to act as a therapeutic intervention on a consumer-available virtual reality headset.

Group Type EXPERIMENTAL

Virtual Eye Rotation Vision Exercises (VERVE)

Intervention Type DEVICE

A video game designed with elements of vision therapy will be delivered to participants utilizing consumer-available virtual reality headsets (VIVE Pro Eye).

Interventions

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Virtual Eye Rotation Vision Exercises (VERVE)

A video game designed with elements of vision therapy will be delivered to participants utilizing consumer-available virtual reality headsets (VIVE Pro Eye).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 9 years and older
* CISS score ≥ 16
* Best-corrected distance visual acuity of 20/25 or better in each eye
* Random dot stereopsis appreciation of 500 seconds of arc or better
* Parent or subject understands the protocol and is willing to enroll in the study

Exclusion Criteria

* Constant strabismus at distance or near
* Vertical heterophoria ≥ 2 ∆ at distance or near
* ≥ 2 line interocular difference in best-corrected visual acuity
* Near point of accommodation \> 20 cm in either eye as measured by push-up method
* Manifest or latent nystagmus
* Non-strabismic binocular vision and accommodative disorders associated with known disease of the brain
* Diseases known to affect accommodation, vergence, or ocular motility such as multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, Parkinson disease
* Any ocular or systemic medication known to affect accommodation or vergence such as anti-anxiety agents (e.g., Librium or Valium), anti-arrhythmic agents (e.g., Cifenline, Cibenzoline), anti-cholinergics, bladder spasmolytic drugs (e.g., Propiverine), hydroxychloroquine, chloroquine, phenothiazines (e.g., Compazine, Mellaril, Thorazine), tricyclic antidepressants (e.g., Elavil, Nortriptyline, Tofranil)
* Inability to comprehend and/or perform any study-related test or procedure

Minimum Eligible Age

9 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No