Efficacy of Botulinum Toxin Type A for Acute Acquired Comitant Esotropia: An Age-Stratified Two-Year Follow-Up Study
1 other identifier
interventional
276
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedFirst Submitted
Initial submission to the registry
April 28, 2025
CompletedFirst Posted
Study publicly available on registry
May 13, 2025
CompletedMay 13, 2025
April 1, 2025
4 years
April 28, 2025
May 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
the sensory success rate
2 years
Other Outcomes (1)
the hazard ratio (HR) for the risk of AACE relapse
2 years
Study Arms (1)
To assess and compare the long-term efficacy of botulinum toxin type A （BTXA) in the treatment of ac
OTHERInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2025
First Posted
May 13, 2025
Study Start
January 1, 2019
Primary Completion
January 1, 2023
Study Completion
June 1, 2023
Last Updated
May 13, 2025
Record last verified: 2025-04