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Behavioural Intervention

Virtual Reality Vision Therapy for Eye Movement Disorders (VRVT - VERVE Trial)

Phase < 1

Recruiting

Led By Mitchell M Scheiman, OD, PhD

Research Sponsored by OculoMotor Technologies

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 9 years and older

Be younger than 65 years old

Must not have

Manifest or latent nystagmus

Non-strabismic binocular vision and accommodative disorders associated with known disease of the brain

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 weeks post-therapy

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study how treating eye coordination and focusing problems with virtual reality games can improve eye muscle responses and reduce eyestrain symptoms. The study will use a virtual reality headset to play a custom

Who is the study for?

This trial is for individuals aged 9 and older with eye coordination or focusing issues, specifically those with a CISS score of 16 or higher. Participants must have good vision (20/25) in each eye and be able to appreciate depth perception. They also need to understand the study and agree to participate.

What is being tested?

The VERVE trial tests if playing a custom video game using virtual reality headsets can improve eye muscle responses and reduce eyestrain symptoms in people with eye movement disorders or convergence insufficiency.

What are the potential side effects?

Potential side effects may include temporary discomfort like dizziness, headaches, or nausea due to the use of virtual reality headsets as well as possible eyestrain from engaging in vision exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 9 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have nystagmus.

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I have vision problems not caused by eye misalignment but related to a brain condition.

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I understand and can do all the tests or procedures in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 weeks post-therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 weeks post-therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks post-therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Near Point of Convergence

Positive Fusional Vergence

Secondary study objectives

Convergence Insufficiency Symptom Survey (CISS)

Core Elements of Gaming Experience Questionnaire

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Active Virtual Reality-Based Vision TherapyExperimental Treatment1 Intervention

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.

0 / 4Eligibility criteria met