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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