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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
276
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.
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
the cumulative motor success rate
Kaplan-Meier survival analyses were conducted to evaluate the cumulative motor success rate. A successful motor outcome was defined as achieving orthotropic alignment within 8 PD at both near (33 cm) and distance (6 m) fixation, accompanied by complete resolution of diplopia.
Time frame: 2 years
the sensory success rate
The sensory success rate was calculated as the proportion of patients achieving successful sensory outcomes among all AACE patients receiving BTXA treatment, expressed as: Sensory success rate = (Number of AACE patients with successful sensory outcomes post-BTXA) / (Total number of AACE patients treated with BTXA) × 100% Sensory success was defined as the restoration of stereopsis.
Time frame: 2 years
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