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NOT YET RECRUITING
NCT07470164
PHASE3

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

Sponsor: Jaeb Center for Health Research

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

4 Months - 17 Years

Study Type

INTERVENTIONAL

Enrollment

244

Start Date

2027-01

Completion Date

2030-01

Last Updated

2026-04-06

Healthy Volunteers

No

Conditions

Interventions

DRUG

Botulinum toxin A

BTX-A 4.0 units to each medial rectus

PROCEDURE

bilateral medial rectus recession

Graded bilateral medial rectus recession