NCT03266081撤回2 期
Improving Epiphora & Ptosis With Bupivacaine
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change from Baseline Lacrimal Tear Lake at 6 months
研究概览
简要总结
The objective of this study is to investigate quantitative improvement in excessive tearing after administration of Bupivacaine, a local anesthetic, into the affected eyelids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients age 18 and above, patients with unilateral or bilateral excessive tearing.
排除标准
- •Pregnant females, vulnerable populations, patients with severe hepatic disease, or patients using monoamine oxidase inhibitors or tricyclic antidepressants, which are contraindicated with bupivacaine and norepinephrine combinations.
研究组 & 干预措施
0.75% bupivacaine
Experimental
干预措施: 0.75% bupivacaine (Drug)
结局指标
主要结局
Change from Baseline Lacrimal Tear Lake at 6 months
时间窗: measurements at baseline and 6 months
Measurement of the height (in mm) of the tear film in the lower conjunctival cup de sac, obtained during slit lamp examination of the eye
次要结局
- Change from baseline Lid distraction at 6 months(measurements at baseline and 6 months)
- Change from baseline Lid snap back at 6 months(measurements at baseline and 6 months)
研究者
Albert Wu
Assistant Professor, Ophthalmology
Stanford University
研究点 (1)
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