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Virtual Reality Games for Amblyopia Treatment

This study is testing if using Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games can improve vision in children with amblyopia (sometimes called "lazy eye"). Participants, aged 5 to 17, will use these virtual reality games for about 25 minutes a day, 6 days a week, for 16 weeks. Researchers want to see if this treatment is more effective at improving vision in the amblyopic eye, as well as other visual skills and quality of life, compared to just wearing glasses for 16 weeks. The main goal is to measure the change in vision in the amblyopic eye over time. The study is currently unclear on its recruitment status.

Study design
This interventional study plans to enroll 8 participants. It compares two treatment periods to see which is more effective.
What's involved
Participants will use Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for approximately 25 minutes a day, 6 days a week, for 16 weeks. Optical correction (glasses) may also be used if needed.
Compensation
Not stated in the trial record.
Follow-up
Vision in the amblyopic eye will be measured at baseline, 16 weeks, and 32 weeks.

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NCT06049459

Novel Amblyopia Treatment With Virtual Reality Games

Recruiting
NAAges 5–17InterventionalTreatment
Marjean Kulp
~8 participants
Updated 2025-07-22 on ClinicalTrials.gov
What's tested:Optical CorrectionTherapeutic Dichoptic Virtual Reality Games

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Difference in Mean Change in Amblyopic Eye Visual Acuity
Measured over Baseline to 16 weeks versus 16 weeks to 32 weeks

Conditions

Amblyopia

Explore related trials

Amblyopia

Where it's being run

1 sites across 1 states
Ohio1

Who to contact

Marjean T Kulp, OD, MS
[email protected]
614-688-3336
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Eligibility criteria

Inclusion

Moderate to severe unilateral amblyopia (logMAR best corrected visual acuity 0.3 to 1.3) associated with anisometropia and/or strabismus of ≤5pd
Age normal VA in the nonamblyopic eye
Spectacle correction (if required) worn for at least 16 weeks, or until stability of VA is demonstrated (\<0.1 logMAR change by the same testing method measured on 2 exams at least 8 weeks apart)
Interocular difference of ≥ 3 lines
No amblyopia treatment in the past 2 weeks
An interpupillary distance of 52-72 mm (inclusive)

Exclusion

Myopia greater than -6.00 diopters (D) spherical equivalent in either eye.
Previous intraocular or refractive surgery.
Previous dichoptic treatment \> 2 weeks in duration
Ocular co-morbidity that may reduce visual acuity determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met).
Diplopia more than once per week over the last week prior to enrollment by parental report.
Down syndrome or cerebral palsy.
Light-induced seizures
Known simulator sickness
Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities are not excluded.

What this trial measures

  • Difference in Mean Change in Amblyopic Eye Visual AcuityBaseline to 16 weeks versus 16 weeks to 32 weeks

    Optical correction worn for testing using Amblyopia Treatment Study (ATS) protocol; HOTV for ages 5-6 years; E-ETDRS for ages 7 years and older