Video Treatment for Amblyopia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Asynchronous 3D movies, Patching.
- Who it may be relevant to
- Registry conditions: Amblyopia. Basic parameters: 3 years — 7 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 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).
Interventions
- Device Asynchronous 3D movies
3D movies streamed at home for viewing on a handheld lenticular 3D screen - Device Patching
Adhesive patch to cover the fellow eye
Primary outcome measures
- Change in amblyopic eye visual acuity using a logMAR chart [Time frame: 6 weeks]
Secondary outcome measures (9)
- Change in amblyopic eye visual acuity using a logMAR chart [Time frame: 2, 8, and 10 weeks]
- Change in extent suppression assessed with the W4 test [Time frame: 6 weeks]
- Change in stereoacuity assessed with the Randot Preschool Stereoacuity Test [Time frame: 6 weeks]
- Change in motor skills assessed with the Movement Assessment Battery for Children -2 [Time frame: 6 weeks]
- Change in self perception assessed with the Pictorial Scale of Perceived Competence and Social Acceptance for Young Children [Time frame: 6 weeks]
- Change in quality of life assessed with the Pediatric Eye Questionnaire [Time frame: 6 weeks]
- Proportion of children who have recovered [Time frame: 2, 6, 8, and 10 weeks]
- Adherence to patching measured with a sensor and adherence to viewing videos measured with the streaming log data [Time frame: 2,4, and 6 weeks]
- Change in depth of suppression assessed with the contrast balance index [Time frame: 6 weeks]
Eligibility criteria
Inclusion criteria
- aged 3-7 years
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Retina Foundation — Dallas
Identifiers
NCT: NCT05439200 · RFSW113B · R01EY022313