Novel Amblyopia Treatment With Dichoptic, Disparity-guided, Hand-Eye Coordination Enhanced, Serious, Virtual Reality Games
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Amblyopia
- Sponsor
- Marjean Kulp
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Difference in Mean Change in Amblyopic Eye Visual Acuity
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief 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
Investigators
Marjean Kulp
Professor
Ohio State University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Difference in Mean Change in Amblyopic Eye Visual Acuity
Time Frame: Baseline to 16 weeks versus 16 weeks to 32 weeks
Optical correction worn for testing using Amblyopia Treatment Study (ATS) protocol; HOTV for ages 5-6 years; E-ETDRS for ages 7 years and older
Secondary Outcomes
- Difference in Mean Change in Amblyopic-Eye Contrast Sensitivity(Baseline to 16 weeks versus 16 weeks to 32 weeks)
- Difference in Change in Stereoacuity/Binocularity(Baseline to 16 weeks versus 16 weeks to 32 weeks)
- Difference in Mean Change in reading eye movements(Baseline to 16 weeks versus 16 weeks to 32 weeks)
- Difference in Mean Change in Attention(Baseline to 16 weeks versus 16 weeks to 32 weeks)
- Difference in Mean Change in Pediatric Eye Questionnaire (PedEyeQ)(Baseline to 16 weeks versus 16 weeks to 32 weeks)
- Difference in Mean Change in visual-motor integration(Baseline to 16 weeks versus 16 weeks to 32 weeks)