A Randomized Trial of Botulinum Toxin A vs Strabismus Surgery for Esotropia >10 to ≤30PD

Childhood esotropia (ET) is a common cause of visual disability, and its early management is critical for optimal visual and developmental outcomes. The proposed study addresses a need to evaluate botulinum toxin A (BTX-A) as a less invasive, cost-effective alternative to incisional strabismus surgery. If BTX-A is demonstrated to be non-inferior to incisional strabismus surgery in treating ET \>10 to ≤30PD, this could reduce surgical and anesthesia-related risks in infants, lower the economic burden on families and healthcare systems, and reduce disparities in access to care, particularly in underserved settings where surgical resources are limited.

NCT Number	NCT07470164
Lead Sponsor	Jaeb Center for Health Research Collaborators: National Eye Institute (NEI), Pediatric Eye Disease Investigator Group
Conditions	Esotropia
Enrollment	244 participants
Start Date	2027-01
Primary Completion	2030-01 (estimated)
Study Completion	2030-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-06