| NCT ID | NCT05440448 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Retina Foundation of the Southwest |
| Condition | Amblyopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2024-04-22 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2024-04-22 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to determine whether a patch-free occlusion therapy 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 the treatment.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05440448 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 12 Years, studying Amblyopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05440448 currently recruiting?
Yes, NCT05440448 is actively recruiting participants. Contact the research team at ebirch@retinafoundation.org for enrollment information.
Where is the NCT05440448 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT05440448 clinical trial?
NCT05440448 is sponsored by Retina Foundation of the Southwest. The trial plans to enroll 68 participants.