Status:

COMPLETED

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

Lead Sponsor:

Second Affiliated Hospital, School of Medicine, Zhejiang University

Conditions:

Acute Acquired Comitant Esotropia

Eligibility:

All Genders

Phase:

NA

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 g...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2023

Estimated Enrollment :

276 Patients enrolled

Trial Details

Trial ID

NCT06966999

Start Date

January 1 2019

End Date

June 1 2023

Last Update

May 13 2025

Active Locations (1)

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1

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310000