Role of endothelin-and Nitric Oxide-system in the Regulation of Optic Nerve Head Blood Flow During Changes in Ocular Perfusion Pressure
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- ONH pressure-flow relationship
研究概览
简要总结
Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in perfusion pressure. The existence of an effective autoregulation in the optic nerve circulation has been shown in animals and humans. The exact mechanism behind this autoregulation is still unknown. The motive for the investigation of optic nerve head (ONH) blood flow autoregulation is to enhance the understanding of pathologic eye conditions associated with ocular vascular disorders. To clarify the regulatory mechanisms of ONH microcirculation is of critical importance to understand the pathophysiology of glaucoma because there is evidence that glaucoma is associated with optic nerve head ischemia. Several studies indicate that a disturbed autoregulation might contribute to glaucomatous optic neuropathy. Previous findings suggest endothelial dysfunction in glaucomatous optic neuropathy, in particular alterations in endothelin- and nitric oxide- system, which both play an important role in local regulation of vascular tone.
In the present study, changes in ocular perfusion pressure will be performed during administration of drugs, which may potentially alter the pressure-flow relationship. These drugs include endothelin-1 and the nitric oxide synthase inhibitor NG-monomethyl-L-arginine (L-NMMA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged between 18 and 35 years, nonsmokers
- •Body mass index between 15th and 85th percentile (Must et al. 1991)
- •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 < 1 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 of hypersensitivity to the trial drug or to drugs with a similar chemical structure
- •History or presence of systemic or pulmonary hypertension, or other cardiac or pulmonary diseases
- •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
结局指标
主要结局
ONH pressure-flow relationship
时间窗: up to 3 study days
次要结局
未报告次要终点
研究者
Gerhard Garhofer
Assoc. Prof. PD Dr.
Medical University of Vienna
