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临床试验/NCT01840202
NCT01840202已完成不适用

Correlation Between Submacular and Peripapillary Choroidal Tissue and Ocular Blood Flow in Glaucoma Patients

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 770 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
770
试验地点
1
主要终点
Comparison of the Retrobulbar Arteries Doppler Waveform between glaucoma patients and healthy controls

研究概览

简要总结

Glaucoma is a leading cause of blindness worldwide, whose treatment - intraocular pressure lowering - is only partially effective in preventing disease progression. Accordingly, other variables, such as ocular blood flow-related factors, have been implicated in disease pathogenesis. However, most findings involving vascular variables come from partial, small-scale studies. Furthermore, recent technological advances have identified a number of ocular blood flow variables that have yet to be tested in large scale trials. Therefore, a study that specifically aims at uncovering the role of vascular aspects in glaucoma is needed.

For this purpose, a cross-sectional, observational case-control study will be conducted in the University Hospitals Leuven. This will be the largest-yet study on the subject, involving more than 750 patients. This will allow the creation of a specific cohort of patients where the vascular aspects are thought to be particularly important (low-tension glaucoma). It will use the largest combination yet of vascular-related measuring techniques (dynamic contour tonometry, optic coherent tomography, colour Doppler imaging and retinal oximetry)

详细描述

  1. Demographic and clinical ophthalmology-related examination data will be collected, including intraocular pressure measurement using dynamic contour tonometry
  2. Visual field testing will be performed.
  3. Structural damage will be documented by a retinal nerve fiber layer analysis (through Heidelberg Retinal Tomograph)
  4. High Definition Optical coherent tomograph imaging of the submacular and peripapillary choroidal thickness will be performed.
  5. Color Doppler Imaging of the retrobulbar vessels will be performed, with analysis of the Doppler waveform (peak systolic, end diastolic velocities and resistivity index)
  6. Retinal oximetry will be performed with the analysis of the arterial and venous saturations of retinal vessels

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • individuals over 18 years old
  • willing to sign an informed consent and able to comply with the requirements of the study
  • having no other ocular diseases besides glaucoma

排除标准

  • history of ocular trauma
  • intraocular surgery (except for cataract surgery)
  • eye disease (except glaucoma)
  • systemic diseases with ocular involvement like diabetes

结局指标

主要结局

Comparison of the Retrobulbar Arteries Doppler Waveform between glaucoma patients and healthy controls

时间窗: Participants will be followed for the duration of hospital stay, an expected average of 2 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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