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临床试验/NCT04044274
NCT04044274已完成不适用

Evaluation of a Novel Method for Increasing Intraocular Pressure in Healthy Subjects

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2019年7月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
1
主要终点
Intraocular pressure (IOP)

研究概览

简要总结

Adequate perfusion is necessary for maintaining tissue function. This applies also for the eye, in which ocular perfusion pressure (OPP) is generally estimated as the difference between mean arterial pressure (MAP) and intraocular pressure (IOP). In the latter formula, IOP substitutes for central retinal venous pressure (CRVP), which is assumed to be slightly higher than IOP to allow blood flow to exit the eye. It has, however, been found that in some patients CRVP is elevated and significantly higher than IOP, which would lead to a decrease in OPP which is not taken in account with the proposed formula. Therefore, techniques for measurement of CRVP are warranted. Recently, a new, method for measurement of this parameter without corneal contact has been introduced. Briefly, with this method, IOP is elevated until the vein collapses, which then equals CRVP. In the present study this technique will be applied in 12 healthy subjects to validate whether the values that are preset by the device correlate to measurements obtained with standard Goldmann applanation tonometry. For this purpose, IOP will be experimentally increased in steps of approximately 5mmHg until it reaches 40mmHg as measured by applanation tonometry. After a resting period of 30 minutes, IOP will be again increased stepwise to 40 mmHg while retinal vessel diameters will be monitored using dynamic vessel analyzer. During this session CRVP will be measured. After another resting period of 30 minutes IOP will be stepwise increased a third time and after each step OCT, OCT-A and OCT EDI will be performed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

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
  • •Non-smokers
  • •Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
  • •Normal ophthalmic findings, ametropia < 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 (except contraceptives)
  • •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • •Blood donation during the previous 3 weeks
  • •Pregnancy, planned pregnancy or lactating

研究组 & 干预措施

IOPstim

Experimental

干预措施: IOPstim (Device)

IOPstim

Experimental

干预措施: Suction Cup (Device)

结局指标

主要结局

Intraocular pressure (IOP)

时间窗: 15 Minutes

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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