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临床试验/NCT02028481
NCT02028481已完成不适用

Air Tamponade in Macular Holes < 400 μm

Helse Stavanger HF2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2013年12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
13
试验地点
2
主要终点
Closure rate of macular hole

研究概览

简要总结

Macular hole is a hole formation which takes place in the center of the retina. Such a hole needs surgical steps in order to close. Closure of the macular hole will lead to a substantially improvement of vision in most cases. Following macular hole surgery a tamponade of intraocular gas is normally injected in order to keep the macula dry for the postoperative period. Postoperative face down position for a week was earlier standard. Several authors report of good closure rates with both air tamponade or lack of face down positioning. In this study standard pars plana vitrectomy with peeling of the internal limiting membrane (ILM) will be performed. The gas tamponade will be replaced by air. Postoperative face down positioning will not be used. Only macular holes less than 400 μm will be included.

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

性别
All
接受健康志愿者

入选标准

  • Primary macular hole less than 400 μm in diameter
  • Duration of symptoms less than 36 months
  • Informed consent

排除标准

  • Previous vitreomacular surgery
  • Myopia more than 6 diopters
  • Ocular trauma
  • Disease affecting visual function

结局指标

主要结局

Closure rate of macular hole

时间窗: 1 month after enrollment

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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