Effectiveness of Virtual Reality Vision Therapy - VERVE

Study Overview
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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.

Official Title
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Effectiveness of Vision Therapy in a Virtual Reality Headset

Conditions
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Convergence Insufficiency

Intervention / Treatment
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* Device: Virtual Eye Rotation Vision Exercises (VERVE)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Virtual Reality-Based Vision Therapy<br>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. | Device: Virtual Eye Rotation Vision Exercises (VERVE)<br>* A video game designed with elements of vision therapy will be delivered to participants utilizing consumer-available virtual reality headsets (VIVE Pro Eye).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Fusional Vergence | Normal range is >15 Prism Diopters | up to 4 weeks post-therapy | 
| Near Point of Convergence | Normal range is < 6 cm | up to 4 weeks post-therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Convergence Insufficiency Symptom Survey (CISS) | Normal range is < 21 for adults and < 16 for pediatrics | up to 4 weeks post-therapy | 
| Vision Quality of Life with Time Survey (VisQuaL-T) | Normal range is > 2.5 | up to 4 weeks post-therapy | 
| Core Elements of Gaming Experience Questionnaire | User experience rating | up to 4 weeks post-therapy |