Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04691427
Recruitment Status : Not yet recruiting
First Posted : December 31, 2020
Last Update Posted : March 15, 2021
Sponsor:
Collaborators:
New Jersey Institute of Technology
Salus University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Convergence Insufficiency Device: Virtual Eye Rotation Vision Exercises (VERVE) Early Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Examiner (Outcomes Assessor) will be masked by pooling participants from another study.
Primary Purpose: Treatment
Official Title: Effectiveness of Vision Therapy in a Virtual Reality Headset
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

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).




Primary Outcome Measures :
  1. Positive Fusional Vergence [ Time Frame: up to 4 weeks post-therapy ]
    Normal range is >15 Prism Diopters

  2. Near Point of Convergence [ Time Frame: up to 4 weeks post-therapy ]
    Normal range is < 6 cm


Secondary Outcome Measures :
  1. Convergence Insufficiency Symptom Survey (CISS) [ Time Frame: up to 4 weeks post-therapy ]
    Normal range is < 21 for adults and < 16 for pediatrics

  2. Vision Quality of Life with Time Survey (VisQuaL-T) [ Time Frame: up to 4 weeks post-therapy ]
    Normal range is > 2.5

  3. Core Elements of Gaming Experience Questionnaire [ Time Frame: up to 4 weeks post-therapy ]
    User experience rating



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 head trauma or 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04691427


Contacts
Layout table for location contacts
Contact: Chang Yaramothu, PhD 9735585456 cto@omtvr.com

Locations
Layout table for location information
United States, New Jersey
OculoMotor Technologies
Newark, New Jersey, United States, 07103
Contact: Chang Yaramothu, PhD       cto@omtvr.com   
United States, Pennsylvania
The Eye Institute at Salus University
Philadelphia, Pennsylvania, United States, 19141
Contact: Mitchell Scheiman, OD, PhD       cmo@omtvr.com   
Sponsors and Collaborators
OculoMotor Technologies
New Jersey Institute of Technology
Salus University
Investigators
Layout table for investigator information
Study Chair: Chang Yaramothu, PhD OculoMotor Technologies
Principal Investigator: Tara L Alvarez, PhD OculoMotor Technologies
Principal Investigator: Mitchell M Scheiman, OD, PhD OculoMotor Technologies
Layout table for additonal information
Responsible Party: OculoMotor Technologies
ClinicalTrials.gov Identifier: NCT04691427    
Other Study ID Numbers: OMT-01
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Ocular Motility Disorders
Central Nervous System Diseases
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases