Effectiveness of Virtual Reality Vision Therapy - VERVE (VRVT - VERVE)

Effectiveness of Vision Therapy in a Virtual Reality Headset

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.

Study Overview

• Status: Recruiting
• Conditions: Convergence Insufficiency
• Intervention / Treatment: Device: Virtual Eye Rotation Vision Exercises (VERVE)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Chang Yaramothu, PhD; Phone Number: 9735585456; Email: cto@omtvr.com

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Recruiting
      • OculoMotor Technologies
      • Contact: Chang Yaramothu, PhD; Email: cto@omtvr.com
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Completed
      • The Eye Institute at Salus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: OculoMotor Technologies
• Collaborators: Salus University; New Jersey Institute of Technology
• Investigators: Study Chair: Chang Yaramothu, PhD, OculoMotor Technologies; Principal Investigator: Tara L Alvarez, PhD, OculoMotor Technologies; Principal Investigator: Mitchell M Scheiman, OD, PhD, OculoMotor Technologies

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2021
• Primary Completion (Estimated): August 28, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Strabismus; Ocular Motility Disorders
• Other Study ID Numbers: OMT-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No