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RECRUITINGNA

Novel Amblyopia Treatment With Virtual Reality Games

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

NCT06049459•Marjean Kulp

View on ClinicalTrials.gov

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

Age

5 - 17 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

The Ohio State University College of Optometry

Columbus, Ohio, United States

Key Dates

Start Date

March 14, 2024

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2026

Last Updated

July 22, 2025

Enrollment

ESTIMATED participants

Conditions

Amblyopia

Interventions

Optical Correction

DEVICE

Therapeutic Dichoptic Virtual Reality Games

DEVICE

Contacts

Marjean T Kulp, OD, MS

CONTACT

614-688-3336 kulp.6@osu.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Novel Amblyopia Treatment With Virtual Reality Games

Inclusion Criteria

Exclusion Criteria

Possible Beneficial Effects Of Combined Fluoxetine And Occlusion Therapy In Improving And Maintaining Vision In Amblyopia Using Optical Coherence Tomography Angiography (OCTA) And Visual Evoked Potential (VEP). The Aim Of The Study Is To Evaluate Possible Beneficial Effects For Different Age Groups.

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