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临床试验/NCT04656197
NCT04656197已完成不适用

Identification of the Ocular Microbiome and Its Role on Dry Eye Disease

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年9月30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
80
试验地点
1
主要终点
Characterization of the ocular microbiome

研究概览

简要总结

The primary objective of this study is the characterization of the ocular microbiome in a healthy cohort and in patients with dry eye disease using whole-metagenome shotgun sequencing. Secondary objectives are the identification of differences between the ocular microbiome of healthy controls and patients with dry eye disease as well as between the ocular and the gut microbiome.

详细描述

Dry eye disease is considered to be the most common ocular surface disease worldwide. Recent studies revealed that the ocular microbiome plays an important role in maintaining ocular surface homeostasis and health. Commensals colonizing the ocular surface seem to support the local innate immune system. As the ocular microbiome coordinates several functions together with ocular mucosal and immune epithelial cells, alteration of the microbiome can lead to changes in the integrity of the ocular surface. This can lead to the development of ocular surface related diseases such as dry eye. Inflammation seems to be a key component of dry eye disease in terms of being a propagator as well as a consequence. In contrast to earlier approaches of identifying the microbiome by cultivating with only limited results, it is now possible to provide more details regarding all microbiota residing on the ocular surface due to modern sequencing techniques. Thus, the overall aim of this study is the identification of the role of the ocular microbiome in dry eye disease.

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients willing to sign informed consent
  • Patients 60 years of age or older

排除标准

  • Patients not willing or able to sign informed consent
  • Patients younger than 60 years
  • Wearing contact lenses
  • Recent (3 month) history of use of systemic and/or topical antibiotics
  • Usage of medical eye drops (Lacrycon and other moisturizing eye drops are allowed)
  • Recent (3 month) history of ocular surgery

结局指标

主要结局

Characterization of the ocular microbiome

时间窗: at baseline

次要结局

  • Identification of differences of the ocular microbiome between patients and controls(at baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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