A Randomized Trial of Botulinum Toxin A vs Strabismus Surgery for Esotropia >10 to ≤30PD (NCT07470164) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Randomized Trial of Botulinum Toxin A vs Strabismus Surgery for Esotropia >10 to ≤30PD
244 participantsStarted 2027-01
Plain-language 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.
Who can participate
Age range
4 Months – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
1. A constant or intermittent ET needing intervention with BTX-A or surgery in the judgement of the investigator meeting one of the criteria below:
Infantile Esotropia (IET)
* 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.
Acquired Non-accommodative Esotropia (ANAET)
* 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.
* Residual angle measuring \>10 to ≤ 30 PD by SPCT in the primary position at distance fixation on an accommodative target.
Acquired Partially Accommodative Esotropia (APAET)
* Onset after six months of age by parental history
* Angle decreases 10 PD or more by PACT in the primary position at distance fixation with correction.
* Residual angle measuring \>10 to ≤ 30 PD by SPCT in the primary position at distance fixation on an accommodative target.
2. Age at enrollment:
* For IET: \> 4 months to \<17 years old
* For ANAET or APAET: \>6 months to \<17 years old
3. No myopia ≥ 6.00D SE
4. Current Spectacle Correction at Time of Enrollment
* For IET: No spectacle wear prior to enrollment.
* For ANAET or APAET: Must be wearing spectacles if significant refractive error as defined below based upon a cycloplegic refraction within 6 months of enrollment. If no significant refractive error…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.