An interventional study of Asynchronous 3D movies and Patching in Amblyopia, sponsored by Retina Foundation of the Southwest. Recruiting at 1 site in United States. Open to participants aged 3 Years to 7 Years. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by Retina Foundation of the Southwest · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether viewing asynchronous movies leads to better visual outcomes in young children with amblyopia than standard-of-care occlusion therapy with an adhesive patch and whether this is associated with better adherence to treatment.
This is a single-site randomized clinical trial to compare treatment of amblyopia by viewing asynchronous movies to standard-of-care occlusion therapy with an adhesive patch. Participants will be referred from local pediatric ophthalmologists. Following informed consent, children will complete baseline testing to confirm eligibility and provide pre-treatment measurements of visual acuity, suppression, stereoacuity, motor skills, self-perception, and quality of life. Eligible children will then be randomly allocated to either patch-free occlusion therapy or standard-of-care occlusion therapy with an adhesive patch.
Children will participate in their assigned occlusion therapy at home for 6 weeks (primary outcome). Adherence will be objectively monitored. Vision will be re-assessed at 2 weeks and all tests will be repeated at 6 weeks. The asynchronous movie group will have an option to continue for and additional 2 or 4 weeks (10 weeks total). The standard-of-care occlusion group will be offered the opportunity to use the movie treatment at the 6 week visit through 10 weeks. Children who choose to remain in the study beyond the 6 week primary outcome visit will have vision reassessed at 8 and 10 weeks.
The primary analysis will be a comparison of improvement in amblyopic eye visual acuity (baseline-6 weeks) between the movie group and the standard-of-care patching group. Secondary analyses will include comparisons of adherence to each treatment, comparison of the proportion of children in each group with visual acuity ≤0.1 logMAR (recovered) at 6 weeks and 95% CIs, comparisons of changes in extent of suppression, depth of suppression, stereoacuity, motor skills standard scores, self-perception scores, and PedEyeQ domain scores. Associations among hours of treatment, changes in visual acuity, suppression, and stereoacuity, will be explored and modeled for dose-response relationships. In exploratory analyses, we will examine whether there are additional improvements in visual acuity, suppression, or stereoacuity between 6 and 10 weeks for the movie group (8 and 10 weeks means and 95% CIs).
189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.
This study's planned enrollment of 44 is below the median of 60 across 137 interventional studies indexed under Amblyopia.
Browse Amblyopia studies →Retina Foundation of the Southwest is the lead sponsor of 12 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Asynchronous 3D movies
Device: Asynchronous 3D movies
Standard-of-care patching with an adhesive patch
Device: Patching
3D movies streamed at home for viewing on a handheld lenticular 3D screen
Adhesive patch to cover the fellow eye
Change in amblyopic eye visual acuity using a logMAR chart
change in amblyopic eye logMAR visual acuity relative to baseline
Time frame: 6 weeks
Change in amblyopic eye visual acuity using a logMAR chart
change in amblyopic eye logMAR visual acuity relative to baseline at 2, 8, and 10 weeks
Time frame: 2, 8, and 10 weeks
Change in extent suppression assessed with the W4 test
change in log deg assessed with the W4 test relative to baseline
Time frame: 6 weeks
Change in stereoacuity assessed with the Randot Preschool Stereoacuity Test
change in log arcsec in stereoacuity assessed with the Randot Preschool Stereoacuity Test
Time frame: 6 weeks
Change in motor skills assessed with the Movement Assessment Battery for Children -2
change in standard scores obtained with the Movement Assessment Battery for Children -2 (MABC-2; (normed and scaled 0-19, with 10 as an average score, 5-6 as "at risk", and \<5 as "significant impairment")
Time frame: 6 weeks
Change in self perception assessed with the Pictorial Scale of Perceived Competence and Social Acceptance for Young Children
change in domain scores of the Pictorial Scale of Perceived Competence and Social Acceptance for Young Children (standard scores scaled to range from 0 to 100 for worst to best)
Time frame: 6 weeks
Change in quality of life assessed with the Pediatric Eye Questionnaire
change in domain scores of the Pediatric Eye Questionnaire (PedEyeQ; Rasch calibrated and scaled to score from 0 to 100 for worst to best)
Time frame: 6 weeks
Proportion of children who have recovered
proportion of children who attain amblyopic eye visual acuity of at least 0.1 logMAR
Time frame: 2, 6, 8, and 10 weeks
Adherence to patching measured with a sensor and adherence to viewing videos measured with the streaming log data
cumulative hours of treatment with the patch objectively monitored temperature sensitive Theramon sensor or with movie viewing by monitoring the streaming logs
Time frame: 2,4, and 6 weeks
Change in depth of suppression assessed with the contrast balance index
change in contrast balance index (ratio of amblyopic eye to fellow eye contrast needed to overcome suppression
Time frame: 6 weeks
Plan to share: No
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Retina Foundation of the Southwest