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临床试验/NCT00842764
NCT00842764已完成不适用

Minimally Invasive Holmium:YAG Laser Blepharoplasty

University of California, Irvine2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2009年1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
7
试验地点
2
主要终点
Change in Lower Eyelid Bags.

研究概览

简要总结

The purpose of this research study is to is to evaluate the safety and effectiveness of the FDA approved Holmium:YAG laser for reducing lower eyelid bags.

详细描述

The researchers are interested in learning if the more precise Holmium:YAG laser can effectively tighten the orbital septum, a barrier of the orbit which holds fat in the bony orbit, while resulting in less unintentional surrounding damage and side effects.

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
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • male/female 30 years and older
  • have pronounced lower eyelid fat pads.

排除标准

  • based on medical problems.
  • Previous surgery or trauma to lower eyelid or orbit.
  • pregnant or lactating.

结局指标

主要结局

Change in Lower Eyelid Bags.

时间窗: 2 months

Preoperative and postoperative (postoperative visits were at day 1, 1 week, 1 month, and 2 months) .photographs were evaluated by 6 surgeons on a 5-point Likert scale which 1 indicates worsening, 2 means unchanged, 3 is mild improvement, 4 is moderate improvement, and 5 indicates complete correction.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Beckman Laser Institute and Medical Center

Brian Wong, M.D., Ph.D., Professor Department of Otolaryngology

University of California, Irvine

研究点 (2)

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