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临床试验/NCT00808197
NCT00808197已完成不适用

Choroidal Blood Flow and Progression of Age-Related Macular Degeneration in the Fellow Eye in Patients With Unilateral Choroidal Neovascularisation

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2008年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
1
主要终点
Choroidal blood flow (laser Doppler flowmetry)

研究概览

简要总结

Age-related macular degeneration (AMD) is the chief cause of severe and irreversible loss of vision in developed countries. The prevalence of AMD increases dramatically with age.

The early stage (or dry AMD) is associated with minimal visual impairment and is characterized by large drusen and pigmentary abnormalities in the macula. The late stage is a neovascular, exudative form. This so called exudative AMD includes serous or hemorrhagic detachment of retinal pigment epithelium and choroidal neovascularization leading to severe loss of vision (20/200 or worse). Patients with unilateral CNV (choroidal neovascularisation) have a significant risk of CNV developing in the second eye.

Choroidal blood flow is of great importance for normal visual function. Several reports have provided evidence suggesting that choroidal blood flow is decreased in subjects with AMD. In late stages of AMD angiogenesis leads to the formation of choroidal neovascularization that can cause severe visual impairment by disrupting normal macular function.

The purpose of this evaluation is to investigate a possible link between alterations in choroidal blood flow and the development of CNV and serous detachment in the fellow eye of patients with AMD and unilateral neovascular maculopathy. This longitudinal study may provide important findings with respect to natural history and visual prognosis of patients with neovascularized AMD.

Ocular blood flow will be determined by non-invasive methods, including laser Doppler flowmetry and laser interferometry

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

性别
All
接受健康志愿者

入选标准

  • Male or female patients with unilateral choroidal neovascular AMD and 2-4 risk factors for AMD in the fellow eye.
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant Ametropy < 4 dpt.

排除标准

  • Abuse of alcoholic beverages
  • Participation in a clinical trial in the 3 weeks preceding the study
  • Any signs of diabetic retinopathy
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day

结局指标

主要结局

Choroidal blood flow (laser Doppler flowmetry)

Fundus pulsation amplitude (laser interferometry)

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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