Efficacy of Botulinum Toxin Type A for Acute Acquired Comitant Esotropia: An Age-Stratified Two-Y… (NCT06966999) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of Botulinum Toxin Type A for Acute Acquired Comitant Esotropia: An Age-Stratified Two-Year Follow-Up Study
China276 participantsStarted 2019-01-01
Plain-language summary
The goal of this clinical trial is to assess and compare the efficacy of two-year follow-up botulinum toxin type A （BTXA) in the treatment of acute acquired comitant esotropia (AACE) across five age groups: ≤6 years, \>6 to ≤12 years, \>12 to ≤20 years, \>20 to ≤30 years, and \>30 years. For patients \>12 years presenting with large-angle esotropia (\>50 PD), primary surgical intervention was recommended as the preferred approach to minimize failure and recurrence risk. Conversely, for patients ≤12 years, BTXA injection was maintained as the first-line treatment regardless of the deviation angle.
Who can participate
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.
Inclusion Criteria:
* Clinical diagnosis of acute acquired comitant esotropia (AACE) with sudden onset and diplopia
* Normal eye movements with deviation difference ≤5 prism diopters (PD) in all gaze directions
* Hyperopia \< +3.00 diopters
* \<10 PD reduction in esotropia with hypermetropic spectacle correction
* No prior extraocular muscle surgery
* Absence of congenital/developmental anomalies affecting treatment outcomes
Exclusion Criteria:
* Deviation difference \>5 PD in any gaze direction
* Hyperopia ≥ +3.00 diopters
* History of extraocular muscle surgery
* Presence of congenital/developmental anomalies potentially impacting outcomes
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.
What they're measuring
1
the cumulative motor success rate
Timeframe: 2 years
Trial details
NCT IDNCT06966999
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University