Clinical trial Recruiting at 1 site Interventional Ages 3 to 12

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 typeInterventional
Ages3 Years to 12 Years
SexAll
Enrollment68 (estimated)
SponsorRetina Foundation of the Southwest
Academic / other
Locations1 site (Dallas, Texas)
StatusRecruiting
StartedApril 22, 2024
Main results expectedJanuary 31, 2028
Study endsJune 30, 2028
Registry record updatedJanuary 7, 2026
Trial IDNCT05440448 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.