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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Botulinum toxin A
Drug
BTX-A 4.0 units to each medial rectus
bilateral medial rectus recession
Procedure/Surgery
Graded bilateral medial rectus recession

Treatment groups

244 Participants

are divided into 2 treatment groups

Group A: BotoxExperimental treatment 1 intervention

Group B: SurgeryActive comparator 1 intervention

Trial outcomes

Primary outcomes

Motor Alignment Success

The primary efficacy outcome will be motor alignment success defined as follows: 1. Success is defined as the absence of failure by 1 year. 2. Failure is defined as any of the following post-randomized treatment (BOTOX or SURGERY) up to 1 year: * ET at distance (determined by a cover/uncover test) with a magnitude of \>10 PD by SPCT at or after the 6-month masked exam. * XT at distance at any time during the exam (determined by a cover/uncover test) with a magnitude of \> 10 PD by SPCT at or after the 6-month masked exam. * Second surgery or injection at any time after the initial surgery/injection through 12 months post-procedure.

Time frame

1 Year

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jaeb Center for Health Research

Lead sponsor

National Eye Institute (NEI)

Collaborator

Pediatric Eye Disease Investigator Group