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临床试验/NCT04193917
NCT04193917已完成不适用

Confounding Factors in Ocular Surface Microbiome Research

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2019年11月24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
450
试验地点
2
主要终点
Change in richness and evenness of distribution of the microbial flora, measured as operational taxonomic units, over time

研究概览

简要总结

To elucidate confounding factors in ocular surface microbiome research and to confirm the presence of a core ocular surface microbiome and its temporal stability.

详细描述

The investigator will take a conjunctival sample of both eyes of a group of volunteers together with an extensive questionnaire. Furthermore, 50 volunteers will be sampled repeatedly during one year or two years.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • The subject is fluent in written and verbal Dutch
  • The subject is capable of giving informed consent

排除标准

  • Use of glaucoma drops
  • Use of antibiotic drops < 1 month before sampling

结局指标

主要结局

Change in richness and evenness of distribution of the microbial flora, measured as operational taxonomic units, over time

时间窗: 20 minutes for the first sample and questionnaire, 5 minutes for all other visits

A conjunctival swab will be taken on different points in time to investigate the temporal stability of the conjunctival microbial flora

Richness and evenness of distribution of the microbial flora measured as operational taxonomic units on a single moment

时间窗: 20 minutes for samples and filling the questionnaires

A conjunctival swab and extensive questionnaire will be taken to search for a core ocular surface microbiome and confounding factors

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 (2)

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