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

Primary Purpose

Convergence Insufficiency

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Virtual Eye Rotation Vision Exercises (VERVE)
Sponsored by
OculoMotor Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Convergence Insufficiency

Eligibility Criteria

9 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • OculoMotor Technologies
  • The Eye Institute at Salus University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active Virtual Reality-Based Vision Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Positive Fusional Vergence
Normal range is >15 Prism Diopters
Near Point of Convergence
Normal range is < 6 cm

Secondary Outcome Measures

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

Full Information

First Posted
December 15, 2020
Last Updated
August 12, 2022
Sponsor
OculoMotor Technologies
Collaborators
New Jersey Institute of Technology, Salus University
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1. Study Identification

Unique Protocol Identification Number
NCT04691427
Brief Title
Effectiveness of Virtual Reality Vision Therapy - VERVE
Acronym
VRVT - VERVE
Official Title
Effectiveness of Vision Therapy in a Virtual Reality Headset
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 14, 2021 (Actual)
Primary Completion Date
July 28, 2022 (Actual)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OculoMotor Technologies
Collaborators
New Jersey Institute of Technology, Salus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Convergence Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Examiner (Outcomes Assessor) will be masked by pooling participants from another study.
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Virtual Reality-Based Vision Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Virtual Eye Rotation Vision Exercises (VERVE)
Intervention Description
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 Measure Information:
Title
Positive Fusional Vergence
Description
Normal range is >15 Prism Diopters
Time Frame
up to 4 weeks post-therapy
Title
Near Point of Convergence
Description
Normal range is < 6 cm
Time Frame
up to 4 weeks post-therapy
Secondary Outcome Measure Information:
Title
Convergence Insufficiency Symptom Survey (CISS)
Description
Normal range is < 21 for adults and < 16 for pediatrics
Time Frame
up to 4 weeks post-therapy
Title
Vision Quality of Life with Time Survey (VisQuaL-T)
Description
Normal range is > 2.5
Time Frame
up to 4 weeks post-therapy
Title
Core Elements of Gaming Experience Questionnaire
Description
User experience rating
Time Frame
up to 4 weeks post-therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Yaramothu, PhD
Organizational Affiliation
OculoMotor Technologies
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tara L Alvarez, PhD
Organizational Affiliation
OculoMotor Technologies
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mitchell M Scheiman, OD, PhD
Organizational Affiliation
OculoMotor Technologies
Official's Role
Principal Investigator
Facility Information:
Facility Name
OculoMotor Technologies
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
The Eye Institute at Salus University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Virtual Reality Vision Therapy - VERVE

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