Efficacy of Botulinum Toxin Type A for Acute Acquired Comitant Esotropia: An Age-Stratified Two-Year Follow-Up Study
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About
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.
Enrollment
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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
Trial design
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Allocation
Interventional model
Masking
276 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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