Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07470164 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: ETS4
StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study title expanded, about 7 wordsv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07470164
Lead Sponsor Jaeb Center for Health Research
Collaborators: National Eye Institute (NEI), Pediatric Eye Disease Investigator Group
Conditions
(from sponsor)		 Esotropia
Related terms Esotropia, Strabismus
Enrollment 244 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov