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临床试验/NCT03391518
NCT03391518Unknown不适用

Evaluation of Blood Flow Regulation With Laser Speckle Flowgraphy in Patients With Normal Tension Glaucoma and Healthy Individuals.

Augenabteilung Allgemeines Krankenhaus Linz1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2017年2月5日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
18
试验地点
1
主要终点
Change in ONH blood flow induced by water drinking test

研究概览

简要总结

The study includes Caucasian patients with diagnosis of normal tension glaucoma and age- and sex-matched healthy individuals. Measurements of optic nerve head blood flow will be performed with laser speckle flowgraphy (LSFG). Also, the intraocular pressure (IOP), systolic and diastolic blood pressure, heart rate (HR), mean arterial pressure (MAP) as well as ocular perfusion pressure (OPP) will be evaluated. After baseline measurements individuals will be asked to ingest 800 ml of water in less than five minutes. Measurements will be repeated after 15, 30 and 45 minutes.

研究设计

研究类型
Interventional
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •presence of glaucomatous optic disc changes in biomicroscopy and visual field defects or abnormal circumpapillary retinal nerve fibre layer (RNFL) thinning (evaluated by OCT as defined by the on-board software)
  • •IOP ≤ 21mmHg without therapy
  • •normal open angle in a gonioscopic examination
  • •age > 40 years

排除标准

  • •IOP > 21 mmHg in patients' history
  • •ametropia > 6 diopters
  • •cataract with severity greater than grade 2 of the lens opacities classification system (LOCS) classification
  • •presence of corneal opacities
  • •uncontrolled hypertension with systolic blood pressure (SBP) > 165mmHg and/or diastolic blood pressure (DBP) > 100mmHg

结局指标

主要结局

Change in ONH blood flow induced by water drinking test

时间窗: baseline, after 15, 30 and 45 minutes

ONH blood flow evaluated by laser speckle flowgraphy

次要结局

未报告次要终点

研究者

发起方
Augenabteilung Allgemeines Krankenhaus Linz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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