The Ohio State University College of Optometry
Columbus, Ohio, 43210, United States
Location status: Recruiting
NCT Number: NCT06049459
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
Interested in participating?
Request Info5 year–17 year
All sexes
Interventional
Not applicable
Columbus, Ohio, 43210, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients ages 5 to 17 years of age
Exclusion criteria
Optical correction (if needed)
Virtual Reality Game play for amblyopia treatment
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
Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks
Optical correction worn for testing. Stereoacuity scores (seconds of arc) calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) tests. Lower scores indicate better stereoacuity. Nil (4000) defined as an incorrect response (or lack of an attempt) on the butterfly without a correct response on 800 seconds of arc level of Randot Preschool stereoacuity test. Stereoacuity scores will be ordered and assigned a rank score. Change in stereoacuity will be calculated as the difference in change in ranked score.
Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks
Optical correction worn for testing. Spot Checks;Contrast sensitivity scores range from unable (<0.90), and then from 0.90 to 2.05 (by 0.05 log contrast sensitivity units).
Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks
Optical correction worn for testing. The Children's Color Trails Test (CCTT) is a neuropsychological standardized test that measures attention, divided attention, and speed of mental processing.
Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks
Optical correction worn for testing with Readalyzer eye tracker.
Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks
Optical correction worn for testing. Beery Visual-Motor Integration; standard scores with mean of 100, standard deviation of 15
Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks
Pediatric Eye Questionnaire (PedEyeQ) domain score; scores for questionnaire items will be obtained from published look-up tables available at www.pedig.net; scaled to score from 0 to 100 (worst to best)
Contact information is provided by the study sponsor or research team.
Marjean Kulp
Other
Novel Amblyopia Treatment With Dichoptic, Disparity-guided, Hand-Eye Coordination Enhanced, Serious, Virtual Reality Games
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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