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临床试验/NCT06545981
NCT06545981招募中不适用

Ocular Perfusion in Patients With Idiopathic Intracranial Hypertension

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年5月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
1
主要终点
Optic nerve head blood flow

研究概览

简要总结

The proposed study aims to evaluate optic nerve head blood flow and microcirculation in patients with idiopathic intracranial hypertension. For this purpose, optic nerve head blood flow will be examined in patients with IIH before and after therapy and additionally compared with healthy age- and sex-matched control subjects. In addition, other parameters will be measured, in particular retinal blood flow, retinal oxygen saturation and retinal neurovascular coupling.

详细描述

Idiopathic intracranial hypertension (IIH) is a neuroophthalmological disease, characterized by an increased intracranial pressure (ICP) without an identifiable causative factor. If not properly treated and carefully monitored the disease can even lead to irreversible severe or complete loss of vision or severe irreversible visual field defects, respectively. Given this clinical urgency, precise diagnostic tools become essential for timely decision making.

Laser Speckle Flowgraphy (LSFG) is a non-invasive, in-vivo imaging method, which quantitatively estimates blood flow in the optic nerve head, the choroid, the retina and the iris. LSFG has a low procedural complexity, obtains precise and reproducible measurements and is therefore suitable to assess ocular perfusion.

The proposed study aims to evaluate optic nerve head blood flow and microcirculation in patients with idiopathic intracranial hypertension. For this purpose, optic nerve head blood flow will be examined in patients with IIH before and after therapy and additionally compared with healthy age- and sex-matched control subjects. In addition, other parameters will be measured, in particular retinal blood flow, retinal oxygen saturation and retinal neurovascular coupling.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Optic nerve head blood flow

时间窗: Before the start of the therapy and 6 months after the start of the therapy

Change in optic nerve head blood flow in patients with idiopathic intracranial hypertension before and 6 months after therapy (LSFG).

次要结局

  • Neurovascular coupling(Before the start of the therapy and 6 months after the start of the therapy)
  • Retinal nerve fiber layer thickness(Before the start of the therapy and 6 months after the start of the therapy)
  • Retinal and retinal layer thickness(Before the start of the therapy and 6 months after the start of the therapy)
  • Retinal vessel diameter(Before the start of the therapy and 6 months after the start of the therapy)
  • Retinal oxygen saturation(Before the start of the therapy and 6 months after the start of the therapy)
  • Retinal vessel density(Before the start of the therapy and 6 months after the start of the therapy)
  • Optic nerve head blood flow(Before the start of the therapy and 6 months after the start of the therapy)
  • Choroidal vascularity index (EDI-OCT)(Before the start of the therapy and 6 months after the start of the therapy)
  • Retinal oxygen extraction(Before the start of the therapy and 6 months after the start of the therapy)
  • Ocular perfusion pressure and arterial blood pressure(Before the start of the therapy and 6 months after the start of the therapy)
  • Choroidal thickness (EDI-OCT)(Before the start of the therapy and 6 months after the start of the therapy)

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. med. univ.

Medical University of Vienna

研究点 (1)

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