Novel Amblyopia Treatment With Virtual Reality Games

Recruiting now · Not applicable

Conditions studied: Amblyopia

In brief

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

Key facts

Study ID

NCT06049459

Run by

Marjean Kulp

People needed

8

Starts

2024-03-14

Expected to finish

2026-12-31

Last updated by the study team

2025-07-22

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• The Ohio State University College of Optometry — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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