Video Treatment for Amblyopia

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).

• Change in amblyopic eye visual acuity using a logMAR chart [Срок оценки: 2, 8, and 10 weeks]
• Change in extent suppression assessed with the W4 test [Срок оценки: 6 weeks]
• Change in stereoacuity assessed with the Randot Preschool Stereoacuity Test [Срок оценки: 6 weeks]
• Change in motor skills assessed with the Movement Assessment Battery for Children -2 [Срок оценки: 6 weeks]
• Change in self perception assessed with the Pictorial Scale of Perceived Competence and Social Acceptance for Young Children [Срок оценки: 6 weeks]
• Change in quality of life assessed with the Pediatric Eye Questionnaire [Срок оценки: 6 weeks]
• Proportion of children who have recovered [Срок оценки: 2, 6, 8, and 10 weeks]
• Adherence to patching measured with a sensor and adherence to viewing videos measured with the streaming log data [Срок оценки: 2,4, and 6 weeks]
• Change in depth of suppression assessed with the contrast balance index [Срок оценки: 6 weeks]