跳至主要内容
临床试验/NCT01076309
NCT01076309已完成不适用

Corneal Endothelium Cell Loss After Cataract Extraction in Patients Taking Systemic Sympathetic Alfa-1-a-antagonist Medication (Tamsulosin)

Frederiksberg University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
corneal endothelium cell loss

研究概览

简要总结

The purpose of this study is to determine whether corneal endothelium cell loss during cataract surgery is higher in patients taking Tamsulosin.

详细描述

Cataract surgery in patients taking Tamsulosin is regarded as more challenging for the surgeon because Intraoperative Floppy Iris Syndrome (IFIS) might occur. However, the question is whether this has any practical implication for the outcomes of surgery. In this study we investigate whether cornea is damage during surgery on Tamsulosin patient. In an observational study 30 cataract patients taking Tamsulosin is compared to 30 patients not taking Tamsulosin, but otherwise similar. Number of patients is based on power calculation.

Cornea is examined by specular microscopy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
Male
接受健康志愿者

入选标准

  • cataract needing surgery

排除标准

  • corneal scarring

结局指标

主要结局

corneal endothelium cell loss

时间窗: 3 months

Corneal endothelium cells was evaluated by specular microskopy before and 3 month post-operatively.

次要结局

未报告次要终点

研究者

发起方
Frederiksberg University Hospital
申办方类型
Other

研究点 (1)

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