Novel Amblyopia Treatment With Virtual Reality Games

Last updated: July 17, 2025
Sponsor: Marjean Kulp
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eye Disorders/infections

Vision Loss

Eye Disease

Treatment

Optical Correction

Therapeutic Dichoptic Virtual Reality Games

Clinical Study ID

NCT06049459
2023H0013
  • Ages 5-17
  • All Genders

Study 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

Inclusion

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 ofVA is demonstrated (<0.1 logMAR change by the same testing method measured on 2exams 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

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 ocularexamination performed within the past 7 months (Note: nystagmus per se does notexclude the participant if the above visual acuity criteria are met).

  • Diplopia more than once per week over the last week prior to enrollment by parentalreport.

  • Down syndrome or cerebral palsy.

  • Light-induced seizures

  • Known simulator sickness

  • Severe developmental delay that would interfere with treatment or evaluation (in theopinion of the investigator). Participants with mild speech delay or reading and/orlearning disabilities are not excluded.

Study Design

Total Participants: 8
Treatment Group(s): 2
Primary Treatment: Optical Correction
Phase:
Study Start date:
March 14, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • The Ohio State University College of Optometry

    Columbus, Ohio 43210
    United States

    Active - Recruiting

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