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NCT06049459NARecruiting

Novel Amblyopia Treatment With Virtual Reality Games

Marjean Kulp

Start Date

3/14/2024

Completion Date

12/31/2026

Summary

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

Eligibility Criteria

Age Range: 5 years to 17 years

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.

Interventions

DEVICE

Optical Correction

DEVICE

Therapeutic Dichoptic Virtual Reality Games

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Conditions

Amblyopia

Locations

The Ohio State University College of Optometry

Columbus, Ohio 43210

United States