A Randomized Trial of Botulinum Toxin A vs Strabismus Surgery for Esotropia >10 to ≤30PD
ConditionEsotropia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age4-17
SponsorJaeb Center for Health Research
About this trial
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.
Eligibility criteria
Qualifiers
Onset prior to six months of age by parental history.
Angle measuring >10 to ≤ 30 PD by PACT in the primary position at distance fixation on an accommodative target.
Onset after six months of age by parental history
Angle decreases less than 10 PD by PACT in the primary position at distance fixation with hyperopic correction.
Disqualifiers
None
Trial design
Treatments tested in this trial
- Botulinum toxin A
- bilateral medial rectus recession
Treatment groups
244 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Jaeb Center for Health Research
Lead sponsor
National Eye Institute (NEI)
Collaborator
Pediatric Eye Disease Investigator Group
Collaborator
Source ClinicalTrials.gov