Novel Amblyopia Treatment With Virtual Reality Games
ConditionAmblyopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-17
SponsorMarjean Kulp
About this trial
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
Qualifiers
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
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Optical Correction
- Therapeutic Dichoptic Virtual Reality Games
Treatment groups
8 Participants
are divided into 2 treatment groupsSponsors and collaborators
Marjean Kulp
Lead sponsor
Ohio State University
Sponsor institution
Beta Sigma Kappa - College of Optometrists in Vision Development
Collaborator
VividVision
Collaborator
Source ClinicalTrials.gov