Effectiveness of Virtual Reality Vision Therapy - VERVE

Early Phase 1

Recruiting

• Conditions: Convergence Insufficiency
• Interventions: Device: Virtual Eye Rotation Vision Exercises (VERVE)

• Registration Number: NCT04691427
• Lead Sponsor: OculoMotor Technologies

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2020-12-31
• Study Start: 2021-10-14
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16
• Primary Completion: 2024-08-28
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active Virtual Reality-Based Vision Therapy	Virtual Eye Rotation Vision Exercises (VERVE)	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.

Primary Outcome Measures

Name	Time	Method
Positive Fusional Vergence	up to 4 weeks post-therapy	Normal range is \>15 Prism Diopters
Near Point of Convergence	up to 4 weeks post-therapy	Normal range is \< 6 cm

Secondary Outcome Measures

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

Trial Locations

Locations (2)

The Eye Institute at Salus University; 🇺🇸 Philadelphia, Pennsylvania, United States

OculoMotor Technologies; 🇺🇸 Newark, New Jersey, United States