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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| To assess and compare the long-term efficacy of botulinum toxin type A （BTXA) in the treatment of ac | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A Injection [Botox] | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the hazard ratio (HR) for the risk of AACE relapse | 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. | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310000 | China |
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|
| 2 years |
| ID | Term |
|---|---|
| D004948 | Esotropia |
| ID | Term |
|---|---|
| D013285 | Strabismus |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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