Choroidal Thickness During Changes in Intraocular Pressure and Arterial Blood Pressure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Choroidal thickness
研究概览
简要总结
Age-related macular degeneration (AMD) and glaucoma are among the leading causes of blindness in the western world. Elevated intraocular pressure (IOP) is a well known major risk factor for glaucoma. In addition, there is growing evidence that vascular factors, including arterial hypertension and hypotension, may play a role in the pathogenesis of AMD and glaucoma. To gain more insight into these mechanisms in humans is the primary goal of the present study.
Optical coherence tomography (OCT) delivers three dimensional, volumetric reflectivity information through transparent media in vivo. Moreover, the images show a high choroidal penetration and a resolution comparable to an histologic examination when infrared light sources are used. Because of its non-invasive character, OCT provides an ideal method for diagnosis and monitoring of retinal and choroidal abnormalities.
The present study aims to investigate whether choroidal thickness is temporarily altered by changes in IOP or systemic hemodynamic parameters. IOP will be increased by the use of a suction cup technique, mean arterial blood pressure will be altered by intravenously administered Phenylephrine or Sodium-Nitroprusside.
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
- 是
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 oral contraceptives)
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •Blood donation during the previous 3 weeks History of hypersensitivity to the trial drugs or to drugs with a similar chemical structure
- •History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
- •History of migraine
- •Pregnancy
研究组 & 干预措施
Sodium-Nitroprusside
Nipruss®, Sanol-Schwarz, Monheim, Germany 0, 0.5, 1 and 2 µg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes
干预措施: Phenylephrine (Drug)
Sodium-Nitroprusside
Nipruss®, Sanol-Schwarz, Monheim, Germany 0, 0.5, 1 and 2 µg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes
干预措施: Sodium-Nitroprusside (Drug)
Sodium-Nitroprusside
Nipruss®, Sanol-Schwarz, Monheim, Germany 0, 0.5, 1 and 2 µg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes
干预措施: Suction Cup (Device)
Suction Cup
suction force of 25, 50, 75, and 100 mmHg
干预措施: Goldmann applanation tonometer (Device)
Sodium-Nitroprusside
Nipruss®, Sanol-Schwarz, Monheim, Germany 0, 0.5, 1 and 2 µg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes
干预措施: Goldmann applanation tonometer (Device)
Sodium-Nitroprusside
Nipruss®, Sanol-Schwarz, Monheim, Germany 0, 0.5, 1 and 2 µg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes
干预措施: 1060nm Optical coherence tomography (Device)
Phenylephrine
Neosynephrine®, Winthrop Breon Laboratories New York, NY, USA 0, 0.5, 1 and 2 μg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes
干预措施: Phenylephrine (Drug)
Phenylephrine
Neosynephrine®, Winthrop Breon Laboratories New York, NY, USA 0, 0.5, 1 and 2 μg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes
干预措施: Sodium-Nitroprusside (Drug)
Phenylephrine
Neosynephrine®, Winthrop Breon Laboratories New York, NY, USA 0, 0.5, 1 and 2 μg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes
干预措施: Suction Cup (Device)
Phenylephrine
Neosynephrine®, Winthrop Breon Laboratories New York, NY, USA 0, 0.5, 1 and 2 μg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes
干预措施: Goldmann applanation tonometer (Device)
Phenylephrine
Neosynephrine®, Winthrop Breon Laboratories New York, NY, USA 0, 0.5, 1 and 2 μg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes
干预措施: 1060nm Optical coherence tomography (Device)
Suction Cup
suction force of 25, 50, 75, and 100 mmHg
干预措施: Phenylephrine (Drug)
Suction Cup
suction force of 25, 50, 75, and 100 mmHg
干预措施: Sodium-Nitroprusside (Drug)
Suction Cup
suction force of 25, 50, 75, and 100 mmHg
干预措施: Suction Cup (Device)
Suction Cup
suction force of 25, 50, 75, and 100 mmHg
干预措施: 1060nm Optical coherence tomography (Device)
结局指标
主要结局
Choroidal thickness
时间窗: 18 months
次要结局
- Systolic/diastolic blood pressure (non-invasive)(18 months)
- Intraocular pressure (IOP)(18 months)
研究者
Gerhard Garhofer
Assoc. Prof. Priv. Doz. Dr.
Medical University of Vienna