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临床试验/NCT00914394
NCT00914394终止不适用

Role of Nitric Oxide in Optic Nerve Head Blood Flow Regulation During Experimental Increase of Intraocular Pressure in Healthy Humans

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
12
试验地点
1
主要终点
optic nerve head pressure-flow relationship

研究概览

简要总结

Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance to changes in perfusion pressure. In the eye, several studies have reported that retinal blood flow is autoregulated over a wide range of ocular perfusion pressures. Large scale studies have shown that reduced ocular perfusion pressure is an important risk factor for the prevalence, the incidence and the progression of primary open angle glaucoma.

Former studies that investigated ocular blood flow autoregulation focused mainly on choroidal blood flow. For the optic nerve head only few data are available, although it seems likely that it underlies similar autoregulatory mechanisms.

A previous study investigating choroidal blood flow has shown that nitric oxide (NO) plays a key role in choroidal autoregulation. The present study is designed to test the hypothesis that NO plays a role in optic nerve head autoregulation during increased intraocular pressure (IOP). Therefore, IOP will be experimentally increased using a suction cup device in the absence of presence of either a nitric oxide synthase inhibitor (L-NMMA), an α-receptor agonist (phenylephrine) or placebo. Optic nerve head blood flow will be continuously measured during the procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Men and women aged between 18 and 35 years, nonsmokers
  • Men and women will be included in equal parts
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • Normal findings in the laboratory testings unless the investigator considers an abnormality to be clinically irrelevant
  • Normal ophthalmic findings, ametropia less than 1 diopter

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 (except intake of oral contraceptives)
  • 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
  • Pregnancy

研究组 & 干预措施

Phenylephrine

Active Comparator

干预措施: Goldmann applanation tonometer (Device)

NG-monomethyl-L-arginine (L-NMMA)

Active Comparator

干预措施: Goldmann applanation tonometer (Device)

Phenylephrine

Active Comparator

干预措施: Laser Doppler Flowmetry (Device)

NG-monomethyl-L-arginine (L-NMMA)

Active Comparator

干预措施: NG-monomethyl-L-arginine (L-NMMA) (Drug)

NG-monomethyl-L-arginine (L-NMMA)

Active Comparator

干预措施: Phenylephrine (Drug)

NG-monomethyl-L-arginine (L-NMMA)

Active Comparator

干预措施: Physiological saline solution (as placebo) (Drug)

NG-monomethyl-L-arginine (L-NMMA)

Active Comparator

干预措施: Laser Doppler Flowmetry (Device)

NG-monomethyl-L-arginine (L-NMMA)

Active Comparator

干预措施: Suction cup (Device)

Phenylephrine

Active Comparator

干预措施: NG-monomethyl-L-arginine (L-NMMA) (Drug)

Phenylephrine

Active Comparator

干预措施: Phenylephrine (Drug)

Phenylephrine

Active Comparator

干预措施: Physiological saline solution (as placebo) (Drug)

Phenylephrine

Active Comparator

干预措施: Suction cup (Device)

Physiological saline solution

Placebo Comparator

干预措施: NG-monomethyl-L-arginine (L-NMMA) (Drug)

Physiological saline solution

Placebo Comparator

干预措施: Phenylephrine (Drug)

Physiological saline solution

Placebo Comparator

干预措施: Physiological saline solution (as placebo) (Drug)

Physiological saline solution

Placebo Comparator

干预措施: Laser Doppler Flowmetry (Device)

Physiological saline solution

Placebo Comparator

干预措施: Goldmann applanation tonometer (Device)

Physiological saline solution

Placebo Comparator

干预措施: Suction cup (Device)

结局指标

主要结局

optic nerve head pressure-flow relationship

时间窗: 1 year

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

Gerhard Garhofer

Assoc Prof Priv-Doz Dr

Medical University of Vienna

研究点 (1)

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