Comparing patch-free therapy to traditional patching for amblyopia in children
Official title: Patch-free Occlusion Therapy
Run by Retina Foundation of the Southwest · NCT05440448 · Data updated 2026-11-12
This study is testing if a new patch-free therapy works better than traditional patching for treating amblyopia in young children.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 12 Years |
| Sex | All |
| Enrollment | 68 (estimated) |
| Sponsor | Retina Foundation of the Southwest Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Status | Recruiting |
| Started | April 22, 2024 |
| Main results expected | January 31, 2028 |
| Study ends | June 30, 2028 |
| Registry record updated | January 7, 2026 |
| Trial ID | NCT05440448 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 3-10 years with specific types of amblyopia and a significant interocular visual acuity difference.
✕Probably not a fit
Patients with coexisting ocular or systemic diseases, developmental delays, or severe myopia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While similar approaches have been explored, this specific patch-free method is relatively novel and has not been extensively tested.
Who can join: the full rules
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 it's running
-
Retina Foundation
Dallas, Texas, United States Recruiting
Study contacts
- Study coordinator: Eileen E Birch, PhD
- Email: ebirch@retinafoundation.org
- Phone: 2143633911
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study tests whether a single or small doses of psilocybin can boost the effectiveness of amblyopia treatment in adults.
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Augmented Reality Binocular Therapy for Adult Amblyopia
This trial tests a home-based augmented reality binocular therapy to see if it improves vision in adults 18–40 with anisometropic amblyopia, compared with placebo training.
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Gabor-based visual training for adults with amblyopia
This study tests a computer-based Gabor training program to see if it can improve vision in adults aged 18–39 with amblyopia due to anisometropia or strabismus.
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Noninvasive brain stimulation plus augmented reality vision therapy for anisometropic amblyopia in adults
This trial tests whether adding HD-tDCS to AR-based dichoptic therapy can improve vision in adults with anisometropic amblyopia.
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tDCS for paediatric amblyopia
This study tests whether non-invasive brain stimulation (tDCS) can improve vision for children aged 4–14 with amblyopia who didn’t get enough help from patching.
-
Gamified visual training with occlusion for kids with anisometropic amblyopia
This trial tests two kid-friendly digital games plus patching to see if they improve vision and motivation in children aged 4–7 with anisometropic amblyopia compared with patching alone.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.