Status:
RECRUITING
Novel Amblyopia Treatment With Virtual Reality Games
Lead Sponsor:
Marjean Kulp
Collaborating Sponsors:
Beta Sigma Kappa - College of Optometrists in Vision Development
VividVision
Conditions:
Amblyopia
Eligibility:
All Genders
5-17 years
Phase:
NA
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 cou...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06049459
Start Date
March 14 2024
End Date
December 31 2026
Last Update
July 22 2025
Active Locations (1)
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1
The Ohio State University College of Optometry
Columbus, Ohio, United States, 43210