An interventional study of Optical Correction and Therapeutic Dichoptic Virtual Reality Games in Amblyopia, sponsored by Marjean Kulp. Terminated at 1 site in United States. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Marjean Kulp · Not applicable, Interventional, and Treatment
Slower than anticipated recruitment
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
189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.
This study's enrollment of 3 is below the median of 60 across 137 interventional studies indexed under Amblyopia.
Browse Amblyopia studies →This is the only study on the registry with Marjean Kulp as lead sponsor.
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Patients ages 5 to 17 years of age
Exclusion Criteria:
Optical correction alone (16 weeks) (Each participant will complete both study conditions.)
Device: Optical Correction
Therapeutic (Dichoptic) Virtual Reality Games plus continued optical correction (16 weeks) (Each participant will complete both study conditions.)
Device: Optical Correction · Device: Therapeutic Dichoptic Virtual Reality Games
Optical correction (if needed)
Virtual Reality Game play for amblyopia treatment
Difference in Mean Change in Amblyopic Eye Visual Acuity
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
Difference in Change in Stereoacuity/Binocularity
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
Difference in Mean Change in Amblyopic-Eye Contrast Sensitivity
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
Difference in Mean Change in Attention
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
Difference in Mean Change in reading eye movements
Optical correction worn for testing with Readalyzer eye tracker.
Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks
Difference in Mean Change in visual-motor integration
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
Difference in Mean Change in Pediatric Eye Questionnaire (PedEyeQ)
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)
Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks
Plan to share: No
No publications or documents are linked to this record.
Slower than anticipated recruitment
Slower than anticipated recruitment
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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