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Completed

NCT Number: NCT06966999

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

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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Key information

Conditions

Acute Acquired Comitant Esotropia Cranial Nerve Diseases Esotropia Eye Diseases Nervous System Diseases Ocular Motility Disorders Strabismus

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. the cumulative motor success rate

    Time frame: 2 years

    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.

Secondary outcomes

  1. the sensory success rate

    Time frame: 2 years

    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.

Other outcomes

  1. the hazard ratio (HR) for the risk of AACE relapse

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 13, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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