Effectiveness of Virtual Reality Vision Therapy - VERVE

NCT04691427 | Recruiting Early Phase 1

• 1 other identifier: OMT-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Convergence Insufficiency

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Convergence Insufficiency Symptom Survey (CISS)

  up to 4 weeks post-therapy

• Vision Quality of Life with Time Survey (VisQuaL-T)

  up to 4 weeks post-therapy

• Core Elements of Gaming Experience Questionnaire

  up to 4 weeks post-therapy

Study Arms (1)

Active Virtual Reality-Based Vision Therapy

EXPERIMENTAL

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)

Interventions

Virtual Eye Rotation Vision Exercises (VERVE) DEVICE

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

Active Virtual Reality-Based Vision Therapy

Eligibility Criteria

• Age: 9 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OculoMotor Technologies: lead
• New Jersey Institute of Technology: collaborator
• Salus University: collaborator

Study Sites (2)

OculoMotor Technologies

Newark, New Jersey, 07103, United States

RECRUITING

The Eye Institute at Salus University

Philadelphia, Pennsylvania, 19141, United States

COMPLETED

MeSH Terms

Conditions

Ocular Motility Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cranial Nerve Diseases; Eye Diseases

Study Officials

• Chang Yaramothu, PhD

  OculoMotor Technologies

  STUDY CHAIR

• Tara L Alvarez, PhD

  OculoMotor Technologies

  PRINCIPAL INVESTIGATOR

• Mitchell M Scheiman, OD, PhD

  OculoMotor Technologies

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang Yaramothu, PhD

CONTACT

9735585456; cto@omtvr.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Examiner (Outcomes Assessor) will be masked by pooling participants from another study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 31, 2020
• Study Start: October 14, 2021
• Primary Completion: August 28, 2024
• Study Completion: September 1, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)