Asynchronous Movies for Amblyopia

Retina Foundation of the Southwest

Status: Enrolling

Conditions: Amblyopia

Treatments: Device: Patching; Device: Asynchronous 3D movies

Study type: Interventional

Funder types: Other

Identifiers

NCT05439200

RFSW113B

Details and patient eligibility

About

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.

Full 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).

Enrollment: 44 estimated patients

Sex: All

Ages: 3 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Asynchronous movies

Experimental group

Description:

Asynchronous 3D movies

Treatment:

Device: Asynchronous 3D movies

Standard-of-care patching with an adhesive patch

Active Comparator group

Description:

Standard-of-care patching with an adhesive patch

Treatment:

Device: Patching