Long-Term Outcomes in the Treatment of Infantile and Acquired Esotropia With Botulinum Toxin

Overview

To investigate long-term treatment outcomes of patients receiving botulinum toxin A therapy for infantile and acquired esotropia.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: October 2007

Detailed Description

Participants: 164 patients with infantile esotropia and 89 patients with acquired esotropia. Methods: Patients were injected with botulinum toxin into two medial rectus muscles and followed from 1992 to 2005. Patients were evaluated at 1 week, 2, 6 and 12 months, and then yearly post-injection. Main Outcome Measures: Degree of motor alignment, recurrence rate, incidence of stereopsis, and dissociated vertical deviation along with complications.

Arms, Groups and Cohorts

  • 1
    • infantile esotropia
  • 2
    • acquired esotropia

Clinical Trial Outcome Measures

Primary Measures

  • Degree of motor alignment, recurrence rate, incidence of stereopsis, and dissociated vertical deviation along with complications.
    • Time Frame: Before treatment, weekly after the treatment, and monthly after motor alignment

Participating in This Clinical Trial

Inclusion Criteria

  • infantile esotropia and acquired esotropia Exclusion Criteria:

  • exotropia, high AC/A ratio accommodative esotropia, patients with neurological deficit including cerebral palsy, Down syndrome and mental retardation, and ocular anomalies including retinopathy of prematurity. Patients lost to follow-up at 6 months or less after the last injection were also excluded.

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 5 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Taiwan University Hospital
  • Provider of Information About this Clinical Study
    • Tsai Tzu-Hsun, National Taiwan University Hospital
  • Overall Official(s)
    • Tzu-Hsun Tsai, MD, Principal Investigator, National Taiwan University Hospital

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