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Efficacy of Botulinum Toxin Type A for Acute Acquired Comitant Esotropia: An Age-Stratified Two-Year Follow-Up Study

NCT06966999 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2025-05-13

No results posted yet for this study

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.

Conditions

  • Acute Acquired Comitant Esotropia

Interventions

PROCEDURE

Botulinum Toxin Type A Injection [Botox]

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 & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2023-01-01
Completion
2023-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06966999 on ClinicalTrials.gov