Acute Acquired Comitant Esotropia
Conditions
Keywords
Botulinum toxin, esotropia
Brief 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.
Interventions
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.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the cumulative motor success rate | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the sensory success rate | 2 years | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| the hazard ratio (HR) for the risk of AACE relapse | 2 years | AACE relapse was identified by either the recurrence of diplopic symptoms or the re-emergence of esotropia \>8 PD. The Cox proportional hazards model was used to identify potential risk factors for AACE relapse. |
Countries
China
Outcome results
None listed