Patch-free Occlusion Therapy

Study Overview
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Brief Summary
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The purpose of the study is to determine whether a patch-free occlusion therapy 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 the treatment.

Detailed Description
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This is a single-site randomized clinical trial to compare patch-free occlusion therapy with standard-of-care occlusion therapy with an adhesive patch in young children with amblyopia. 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 12 weeks (primary outcome). Adherence will be objectively monitored with a Theramon sensor. Vision will be re-assessed at 6 weeks and all tests will be repeated at 12 weeks. The patch-free occlusion group will have an option to continue the patch-free occlusion for and additional 6 or 12 weeks (24 weeks total). The standard-of-care occlusion group will be offered the opportunity to use the patch-free treatment at the 12 week visit through 24 weeks. Children who choose to remain in the study beyond the 12 week primary outcome visit will have vision reassessed at 18 and 24 weeks. The primary analysis will be a comparison of improvement in amblyopic eye visual acuity (baseline-12 weeks) between the patch-free occlusion group and the standard-of-care patching group. Secondary analyses will include comparisons adherence to each treatment, comparison of the proportion of children in each group with visual acuity ≤0.1 logMAR (recovered) at 6 and 12 weeks visit and 95% CIs (at 6 and 12 weeks), 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 12 and 24 weeks for the patch-free group (12, 18, and 24 weeks means and 95% CIs).

Official Title
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Patch-free Occlusion Therapy

Conditions
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Amblyopia

Intervention / Treatment
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* Device: Patch-free occlusion therapy
* Device: Adhesive patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 3-10 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 myopia > -3.00D

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 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: Patch-free occlusion therapy<br> | Device: Patch-free occlusion therapy<br>* Use of filters in glasses to provide occlusion therapy<br>|
| Active Comparator: Standard-of-care patching with an adhesive patch<br> | Device: Adhesive patch<br>* Standard-of-care occlusion therapy with an adhesive patch<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 measured with a logMAR visual acuity chart | change in logMAR relative to baseline | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in amblyopic eye visual acuity measured with a logMAR visual acuity chart | change in logMAR relative to baseline | 6,18, and 24 weeks | 
| Adherence to patching or viewing videos with glasses measured with a sensor | cumulative hours of treatment with the patch or glasses used to watch videos objectively monitored with the skin temperature sensitive Theramon sensor | 6 and 12 weeks | 
| Proportion of children who have recovered | Proportion of children who attain amblyopic eye visual acuity of 0.1 logMAR or better | 6 and 12 weeks | 
| Change in extent of suppression assessed with W4 test | changes in log deg measure with W4 test | 6 and 12 weeks | 
| change in stereoacuity assessed with the Randot Preschool Stereoacuity Test | change in log arcsec | 6 and 12 weeks | 
| Change in motor skills assessed with the Movement Assessment Battery for Children-2 | change in Movement Assessment Battery for Children-2 (MABC-2) standard scores relative to baseline (normed and scaled 0-19 for worst to best, with 10=average, 5-6 = at risk, and <5 = significant impairment) | 12 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) | 12 weeks | 
| Improvement in quality of life assesses 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) | 12 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 and 12 weeks |