Skip to content

Effectiveness of Virtual Reality Vision Therapy - VERVE

Effectiveness of Vision Therapy in a Virtual Reality Headset

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04691427
Acronym
VRVT - VERVE
Enrollment
50
Registered
2020-12-31
Start date
2021-10-14
Completion date
2024-09-30
Last updated
2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Convergence Insufficiency

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.

Interventions

DEVICEVirtual 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).

Sponsors

New Jersey Institute of Technology
CollaboratorOTHER
Salus University
CollaboratorOTHER
OculoMotor Technologies
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

Examiner (Outcomes Assessor) will be masked by pooling participants from another study.

Eligibility

Sex/Gender
ALL
Age
9 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Positive Fusional Vergenceup to 4 weeks post-therapyNormal range is \>15 Prism Diopters
Near Point of Convergenceup to 4 weeks post-therapyNormal range is \< 6 cm

Secondary

MeasureTime frameDescription
Convergence Insufficiency Symptom Survey (CISS)up to 4 weeks post-therapyNormal range is \< 21 for adults and \< 16 for pediatrics
Vision Quality of Life with Time Survey (VisQuaL-T)up to 4 weeks post-therapyNormal range is \> 2.5
Core Elements of Gaming Experience Questionnaireup to 4 weeks post-therapyUser experience rating

Countries

United States

Contacts

Primary ContactChang Yaramothu, PhD
cto@omtvr.com9735585456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026