Long-Term Outcomes in the Treatment of Infantile and Acquired Esotropia With Botulinum Toxin
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|ClinicalTrials.gov Identifier: NCT00746304|
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : September 3, 2008
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|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||164 participants|
|Official Title:||Long-Term Outcomes in the Treatment of Infantile and Acquired Esotropia With Botulinum Toxin|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||December 2007|
- 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 ]
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|Ages Eligible for Study:||1 Day to 5 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- infantile esotropia and acquired esotropia
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00746304
|National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|Principal Investigator:||Tzu-Hsun Tsai, MD||National Taiwan University Hospital|
|Responsible Party:||Tsai Tzu-Hsun, National Taiwan University Hospital|
|Other Study ID Numbers:||
|First Posted:||September 3, 2008 Key Record Dates|
|Last Update Posted:||September 3, 2008|
|Last Verified:||September 2007|
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases