跳至主要内容
临床试验/NCT00763659
NCT00763659已完成不适用

Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA)

University of Jena2 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2008年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
172
试验地点
2
主要终点
Optical density of macular pigment

研究概览

简要总结

The primary objective of LUTEGA is it to determine the long term effect (about 1 year) of the supplementation with a fixed combination of lutein/zeaxanthin and omega-3- fatty acids on the optical density (OD) of macular pigment in patients with non- exudative age related maculopathy.

Furthermore, it is to be examined whether changes of the optical density are different dosages dependent. Possible changes of lipofuscin content and effect on drusen in AMD patients are studied. The measurement of optical density of macular pigment uses the 1- wavelength reflection method recording reflection images at 460 nm by a fundus camera. The patients are investigated at baseline and are followed up over one year in four more visits. In addition to the OD- measurement each examination includes standardized visual acuity test (ETDRS), amsler- grid, slit lamp biomicroscopy, fundus photography (color and autofluorescence) and a blood sample.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
50 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All non- exudative forms of age related maculopathy

排除标准

  • Exudative age related maculopathy

结局指标

主要结局

Optical density of macular pigment

时间窗: 12 months

次要结局

未报告次要终点

研究者

发起方
University of Jena
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jens Dawczynski

Prof. Dr. med. jens Dawczynski

University of Leipzig

研究点 (2)

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