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临床试验/NCT00746304
NCT00746304已完成不适用

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

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2007年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
164
试验地点
1
主要终点
Degree of motor alignment, recurrence rate, incidence of stereopsis, and dissociated vertical deviation along with complications.

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
1 Day 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • infantile esotropia and acquired esotropia

排除标准

  • 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.

结局指标

主要结局

Degree of motor alignment, recurrence rate, incidence of stereopsis, and dissociated vertical deviation along with complications.

时间窗: Before treatment, weekly after the treatment, and monthly after motor alignment

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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