Overview
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
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.
