Effect on Tear Functions of Pretarsal and Preseptal Techniques of Botulinum Toxin Type A Injection in Hemifacial Spasm
试验速览
- 阶段
- 2 期
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- tear break up time
研究概览
简要总结
The purpose of this study is to determine whether pretarsal and preseptal techniques of Botulinum toxin type A injection have any effect on tear functions.
详细描述
Botulinum toxin type A has been used for hemifacial spasm since 1986. of Botulinum toxin type A can be subcutaneously injected at pretarsal or preseptal portion of orbicularis muscle. Blepharoptosis has been reported less frequently with pretarsal technique, however dry eye was noticed in one patient treated with pretarsal botulinum toxin type A for cosmetic purpose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient diagnosed with hemifacial spasm
排除标准
- •previous history of botulinum toxin treatment for hemifacial spasm
- •ocular surface disorders
- •tear disorders
- •evidence of infection at or around eyelids
- •pregnant woman
- •other neurologic disease, i.e. OMG
- •coagulopathy or treatment with thrombolytic agent
- •treatment with aminoglycosides, chloroquine, hydroxychloroquine
研究组 & 干预措施
preseptal
干预措施: preseptal injection of botulinum toxin type A (Drug)
pretarsal
干预措施: pretarsal injection of Botulinum toxin type A (Drug)
结局指标
主要结局
tear break up time
时间窗: change from baseline in tear break up time at 12 weeks
unit of measure; minutes
次要结局
- schirmer's test(change from baseline of schirmer's test at 12 weeks)
研究者
kitthisak kitthaweesin
Assoc Prof
Khon Kaen University