Viewing movies as treatment for amblyopia in children
Video Treatment for Amblyopia
This study is testing if watching special movies can help young children with amblyopia see better compared to using a patch on their eye.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 3 Years to 7 Years |
| Sex | All |
| Sponsor | Retina Foundation of the Southwest Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT05439200 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of viewing asynchronous movies as a treatment for amblyopia in young children compared to traditional occlusion therapy using an adhesive patch. The study involves a randomized allocation of participants to either the movie treatment or standard patching, with assessments of visual acuity, adherence, and quality of life conducted at multiple time points. Children aged 3 to 8 years with specific types of amblyopia will be recruited, and their progress will be monitored over a 6-week period, with options for extended participation. The primary outcome will focus on improvements in visual acuity in the amblyopic eye.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 8 years diagnosed with strabismic, anisometropic, or combined mechanism amblyopia.
Not a fit: Patients with significant coexisting ocular or systemic diseases, developmental delays, or severe strabismus may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more engaging and effective treatment option for children with amblyopia, potentially improving adherence and visual outcomes.
How similar studies have performed: While the use of movies as a treatment for amblyopia is a novel approach, similar studies exploring alternative therapies have shown promise in improving adherence and outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas
- Retina Foundation — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Eileen E Birch, PhD
- Email: ebirch@retinafoundation.org
- Phone: 2143633911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.