Clinical trial NCT05440448: Patch-free Occlusion Therapy
Official title: Patch-free Occlusion Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amblyopia
Lead sponsor: Retina Foundation of the Southwest
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2022-06-30
Enrollment: 68
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in amblyopic eye visual acuity measured with a logMAR visual acuity chart
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in amblyopic eye visual acuity measured with a logMAR visual acuity chart
timeFrame: 6,18, and 24 weeks
measure: Adherence to patching or viewing videos with glasses measured with a sensor
timeFrame: 6 and 12 weeks
measure: Proportion of children who have recovered
timeFrame: 6 and 12 weeks
measure: Change in extent of suppression assessed with W4 test
timeFrame: 6 and 12 weeks
measure: change in stereoacuity assessed with the Randot Preschool Stereoacuity Test
timeFrame: 6 and 12 weeks
measure: Change in motor skills assessed with the Movement Assessment Battery for Children-2
timeFrame: 12 weeks
measure: Change in self-perception assessed with the Pictorial Scale of Perceived Competence and Social Acceptance for Young Children
timeFrame: 12 weeks
measure: Improvement in quality of life assesses with the Pediatric Eye Questionnaire
timeFrame: 12 weeks
measure: Change in depth of suppression assessed with the contrast balance index
timeFrame: 6 and 12 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Retina Foundation
state: Texas
Study officials:
References: