Recruiting
Early Phase 1

VERVE

Sponsor:

OculoMotor Technologies

Code:

NCT04691427

Conditions

Convergence Insufficiency

Eligibility Criteria

Sex: All

Age: 9 - 35

Healthy Volunteers: Not accepted

Interventions

Virtual Eye Rotation Vision Exercises (VERVE)

Study Details

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

Study ID

NCT04691427

Start date

Oct 14, 2021

Status verified date

Apr, 2024

Completion date

Sep, 2024

Anticipated

Primary completion date

Aug 28, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 35

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

  • Positive Fusional Vergence [ Time Frame: up to 4 weeks post-therapy ]
  • Near Point of Convergence [ Time Frame: up to 4 weeks post-therapy ]

Central Contacts and Locations

Central contacts

Chang Yaramothu, PhD

9735585456cto@omtvr.com

Locations

OculoMotor Technologies

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Chang Yaramothu, PhD

cto@omtvr.com

More Information

Sponsor

OculoMotor Technologies

Last update posted

Apr 16, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OculoMotor Technologies on 2024-04-16.