Clinical trial NCT05439200: Video Treatment for Amblyopia
Official title: Video Treatment for Amblyopia
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: 44
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in amblyopic eye visual acuity using a logMAR chart
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in amblyopic eye visual acuity using a logMAR chart
timeFrame: 2, 4, 8, and 10 weeks
measure: Change in extent suppression assessed with the W4 test
timeFrame: 6 weeks
measure: Change in stereoacuity assessed with the Randot Preschool Stereoacuity Test
timeFrame: 6 weeks
measure: Change in motor skills assessed with the Movement Assessment Battery for Children -2
timeFrame: 6 weeks
measure: Change in self perception assessed with the Pictorial Scale of Perceived Competence and Social Acceptance for Young Children
timeFrame: 6 weeks
measure: Change in quality of life assessed with the Pediatric Eye Questionnaire
timeFrame: 6 weeks
measure: Proportion of children who have recovered
timeFrame: 2, 4, 6, 8, and 10 weeks
measure: Adherence to patching measured with a sensor and adherence to viewing videos measured with the streaming log data
timeFrame: 2,4, and 6 weeks
measure: Change in depth of suppression assessed with the contrast balance index
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Retina Foundation
state: Texas
Study officials:
References: