RecruitingNot ApplicableNCT06049459

Novel Amblyopia Treatment With Virtual Reality Games

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

Sponsor

Marjean Kulp

Enrollment

8 participants

Start Date

Mar 14, 2024

Study Type

INTERVENTIONAL

Conditions

Amblyopia

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

Min Age: 5 YearsMax Age: 17 Years

Inclusion Criteria7

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 Criteria9

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.