Comparing patch-free therapy to traditional patching for amblyopia in children
Patch-free Occlusion Therapy
This study is testing if a new patch-free therapy works better than traditional patching for treating amblyopia in young children.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 3 Years to 12 Years |
| Sex | All |
| Sponsor | Retina Foundation of the Southwest Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT05440448 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of patch-free occlusion therapy compared to standard adhesive patch therapy in young children diagnosed with amblyopia. The study involves a randomized allocation of participants to either treatment group, with baseline assessments of visual acuity and other related metrics. Over a 12-week period, children will undergo their assigned therapy at home, with adherence monitored using a Theramon sensor. Visual outcomes will be measured at multiple intervals to determine which method yields better results.
Who should consider this trial
Good fit: Ideal candidates are children aged 3-10 years with specific types of amblyopia and a significant interocular visual acuity difference.
Not a fit: Patients with coexisting ocular or systemic diseases, developmental delays, or severe myopia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve visual outcomes and adherence to treatment in children with amblyopia.
How similar studies have performed: While similar approaches have been explored, this specific patch-free method is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 3-12 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 * 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.