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临床试验/NCT00275730
NCT00275730已完成不适用

Effects of Indomethacin on Retinal and Choroidal Blood Flow in Healthy Volunteers

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2006年1月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Retinal and choroidal blood flow

研究概览

简要总结

Prostaglandins (PG) are known to alter regional ocular blood flow and exhibit vasoactive properties in isolated ocular blood vessels. A variety of animal experiments indicate that endogenous PGs play a role in the regulation of retinal (RBF) and choroidal (ChBF) blood flow. There is also evidence that the prostaglandin pathway is involved in the activation of NO production in humans, however, the mechanisms for interactions between PG and NO in ocular vasculature are still unclear.

Animal studies suggest that retinal and choroidal blood flow decrease after administration of indomethacin (a nonspecific cyclooxygenase inhibitor). More recently, it has been shown that indomethacin injected intravenously decreased optic nerve oxygen tension and reduced the CO2 reactivity. This is probably the result of decreased blood flow through vasoconstriction of vessels in the optic nerve. Systemic administration of indomethacin also diminishes cerebral, renal and mesenteric blood flow by an unknown mechanism. However, no clinical trials exist so far investigating the effects of indomethacin on ocular blood flow. Therefore, the aim of this study is to investigate the effect of indomethacin on ocular blood flow in healthy humans.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Double

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Men aged between 18 and 35 years, nonsmokers
  • Body mass index between 15th and 85th percentile
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
  • Normal ophthalmic findings, ametropy < 3 dpt.

排除标准

  • Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
  • Treatment in the previous 3 weeks with any drug
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
  • Blood donation during the previous 3 weeks
  • Ametropy less than 3 dpt

结局指标

主要结局

Retinal and choroidal blood flow

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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