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临床试验/NCT00494325
NCT00494325已完成不适用

The Role of Macular Pigment in Patients With Age-related Macular Degeneration

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2005年10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
480
试验地点
1
主要终点
Incidence of development of late AMD

研究概览

简要总结

In the industrialised world age-related macular degeneration (ARMD) is the leading cause for legal blindness beyond the age of 50 years. Recent studies indicate that the amount and status of the macular pigment (MP) may play a central role in the development and progression of the disease. It has been demonstrated that the MP density can be increased by dietary supplementation. First results of MP density measurements with a modified confocal laser scanning ophthalmoscope show that this method allows to quantify the MP in a clinical setting. The aim of this study is to assess the peak MP density as well as the MP distribution in relation to the risk for ARMD. We will establish reference values for MP density distribution in a normal population and compare these to values obtained from patients with age related maculopathy in a cross-sectional study. For all MP density measurements we will use a modified scanning laser ophthalmoscope and dietary intake of macular pigment will be assessed using a Food Frequency Questionnaire. Clinical examinations will include ETDRS visual acuity, binocular ophthalmoscopy, colour fundus photography and autofluorescence imaging. The results of our study will help assess the relationship of macular pigment density and distribution with ARMD. Additionally, we will be able to identify patients with low MP density, and probably improve the early diagnosis of patients at high risk for developing ARMD. This will be the basis for dietary supplementation of lutein and/or zeaxanthin in patients with high risk for ARMD due to low macular pigment values.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • age related maculopathy

排除标准

  • other macular diseases

结局指标

主要结局

Incidence of development of late AMD

时间窗: End of study

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

Sebastian Wolf

Director

Insel Gruppe AG, University Hospital Bern

研究点 (1)

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