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

NCT ID: NCT06966999

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2023-06-01

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.

Conditions

Acute Acquired Comitant Esotropia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

To assess and compare the long-term efficacy of botulinum toxin type A （BTXA) in the treatment of ac

Group Type: OTHER

Botulinum Toxin Type A Injection [Botox]

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2017-073

Identifier Type: -

Identifier Source: org_study_id