Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
8 participants
INTERVENTIONAL
2024-03-14
2026-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Optical Correction alone
Optical correction alone (16 weeks) (Each participant will complete both study conditions.)
Optical Correction
Optical correction (if needed)
Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical Correction
Therapeutic (Dichoptic) Virtual Reality Games plus continued optical correction (16 weeks) (Each participant will complete both study conditions.)
Optical Correction
Optical correction (if needed)
Therapeutic Dichoptic Virtual Reality Games
Virtual Reality Game play for amblyopia treatment
Interventions
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Optical Correction
Optical correction (if needed)
Therapeutic Dichoptic Virtual Reality Games
Virtual Reality Game play for amblyopia treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
5 Years
17 Years
ALL
No
Sponsors
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Beta Sigma Kappa - College of Optometrists in Vision Development
UNKNOWN
VividVision
UNKNOWN
Marjean Kulp
OTHER
Responsible Party
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Marjean Kulp
Professor
Locations
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The Ohio State University College of Optometry
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023H0013
Identifier Type: -
Identifier Source: org_study_id
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