NCT07470164

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 244 (estimated)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 4 Months – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

After receiving informed consent, participants with ET \>10 to ≤30PD who are otherwise eligible will be randomly assigned to treatment with BTX-A or incisional strabismus surgery; and seen 6 weeks, 6- and 12- months after surgery. The primary outcome is the cumulative probability of motor alignment success by 12 months. Success is defined as the absence of failure by 12 months.

Conditions

• Esotropia

Interventions

Type	Name	Description
DRUG	Botulinum toxin A	BTX-A 4.0 units to each medial rectus
PROCEDURE	bilateral medial rectus recession	Graded bilateral medial rectus recession

Timeline

• Start date: 2027-01-01
• Primary completion: 2030-01-01
• Completion: 2030-01-01
• First posted: 2026-03-13
• Last updated: 2026-04-06

Regulatory

• FDA-regulated drug study