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Novel Amblyopia Treatment With Virtual Reality Games

Novel Amblyopia Treatment With Dichoptic, Disparity-guided, Hand-Eye Coordination Enhanced, Serious, Virtual Reality Games

Who can join

Ages 5 to 17 · All sexes

Inclusion Criteria:

Patients ages 5 to 17 years of age

* 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 Criteria:

* 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.

About the study

The goal of this study is to compare the change in amblyopic eye acuity between treatment periods in children with amblyopia, aged 5-17 years. The main question it aims to answer is:

Is a 16-week course of amblyopia treatment using Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for approx. 25 min/day, 6 days/week more effective for improvement in amblyopic-eye VA, binocularity (stereoacuity, suppression, alignment), contrast sensitivity, attention, oculomotor function, visual-motor integration, and quality of life than 16 weeks of continued glasses alone?

Participants will each serve as their own control and complete:

Treatment period 1: Continued optical correction (glasses) alone for 16 weeks; Treatment period 2: Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for 16 weeks (approx. 25min/day, 6 days/week) plus continued optical correction

What is being tested

• Optical Correction (device)
• Therapeutic Dichoptic Virtual Reality Games (device)

Sponsor: Marjean Kulp · Participants: 8 · Started: Mar 14, 2024

Contact the study team

• Marjean T Kulp, OD, MS · Phone: 614-688-3336

Official record on ClinicalTrials.gov — NCT06049459

Locations in the U.S.

Conditions

• Amblyopia

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.