An interventional study of Patch-free occlusion therapy and Adhesive patch in Amblyopia, sponsored by Retina Foundation of the Southwest. Recruiting at 1 site in United States. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by Retina Foundation of the Southwest · Not applicable, Interventional, and Treatment
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.
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).
Exclusion Criteria:
Device: Patch-free occlusion therapy
Device: Adhesive patch
Use of filters in glasses to provide occlusion therapy
Standard-of-care occlusion therapy with an adhesive patch
Change in amblyopic eye visual acuity measured with a logMAR visual acuity chart
change in logMAR relative to baseline
Time frame: 12 weeks
Change in amblyopic eye visual acuity measured with a logMAR visual acuity chart
change in logMAR relative to baseline
Time frame: 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
Time frame: 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
Time frame: 6 and 12 weeks
Change in extent of suppression assessed with W4 test
changes in log deg measure with W4 test
Time frame: 6 and 12 weeks
change in stereoacuity assessed with the Randot Preschool Stereoacuity Test
change in log arcsec
Time frame: 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")
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 6 and 12 weeks
Plan to share: No
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Retina Foundation of the Southwest