Asynchronous Movies for Amblyopia

Study Overview
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Brief Summary
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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.

Detailed Description
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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 and 4 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).

Official Title
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Asynchronous Movies for Amblyopia

Conditions
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Amblyopia

Intervention / Treatment
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* Device: Asynchronous 3D movies
* Device: Patching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 3-8 years (3-7 primary cohort) male and female strabismic, anisometropic, or combined mechanism amblyopia (visual acuity 0.3-0.8 logMAR) interocular visual acuity difference ≥0.3 logMAR wearing glasses (if needed) for a minimum of 8 weeks with no change in visual acuity at 2 visits ≥4 weeks apart child's ophthalmologist and family willing to forgo standard patching treatment during the study Exclusion Criteria: prematurity ≥8 wk coexisting ocular or systemic disease developmental delay strabismus >5 pd myopia > -3.00D

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Asynchronous movies<br>Asynchronous 3D movies | Device: Asynchronous 3D movies<br>* 3D movies streamed at home for viewing on a handheld lenticular 3D screen<br>|
| Active Comparator: Standard-of-care patching with an adhesive patch<br>Standard-of-care patching with an adhesive patch | Device: Patching<br>* Adhesive patch to cover the fellow eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in amblyopic eye visual acuity using a logMAR chart | change in amblyopic eye logMAR visual acuity relative to baseline | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in amblyopic eye visual acuity using a logMAR chart | change in amblyopic eye logMAR visual acuity relative to baseline at 2, 4, 8, and 10 weeks | 2, 4, 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 | 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 | 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) | 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) | 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) | 6 weeks | 
| Proportion of children who have recovered | proportion of children who attain amblyopic eye visual acuity of at least 0.1 logMAR | 2, 4, 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 | 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 | 6 weeks |