Assessment of the Ocular Microbiome in Health and Disease
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Microbial Colonization
- 发起方
- Vanderbilt University Medical Center
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Normal Ocular Microbiome
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
The objective of this application is to illustrate the core constituents of the ocular surface microbiome, describe factors that promote colonization, and assess the ocular microbiome's role in the health of the anterior segment. We will conduct a prospective, observational cohort study, including a longitudinal analysis of the ocular microbiome in adults.
详细描述
The microbiome is defined as a community of microbial organisms that reside in a specific host niche. There is a growing body of literature on the association between gut microbiome and disease entities such as inflammatory bowel disease, colon cancer and presumably an association that might influence response to treatment in some patients. Recent data suggest the existence of a resident ocular microbiota that may play a protective role in corneal infections \[1-4\]. However, not much is known about the ocular microbiome and its association with disease or response to treatment. The National Eye Institute (NEI) recently hosted a symposium to discuss challenges to characterize the ocular microbiome and its role in promoting or preventing ocular diseases. One of the major challenges discussed is the lack of a normative population- based database describing the ocular microbiome. In response the NEI as part of the Anterior segment initiative put out an RFA requesting proposals on methods of collection of biological samples and associated clinical data (e.g. demographic, residence, medications, allergies); processing of samples to extract analytes (e.g., DNA, RNA, protein, metabolites) and characterizing microorganisms in a low biomass niche, specifically the ocular surface using16S rRNA marker gene, whole metagenome sequencing (WMS), and metatranscriptomics approaches.
研究者
Sapna Gangaputra
Assistant Professor
Vanderbilt University Medical Center
入排标准
入选标准
- •We will include subjects who meet all of the following criteria:
- •18 years of age or older
- •Provide informed consent
- •Cohort A - normal eyes with no ocular disease
- •Cohort B - primary open angle glaucoma/Ocular hypertension defined as mild glaucoma which is well controlled with no more than one drop of prostaglandin use daily for the past 6 months
- •Cohort C - non-infectious keratopathy not using any prescription medication (OTC artificial tears are acceptable)
- •Cohort D - Dry AMD (age related macular degeneration)
- •Cohort E - Wet AMD
- •Cohort F - diabetic retinopathy
排除标准
- •We will exclude subjects who meet all of the following criteria:
- •Prior ocular disease either of the anterior or posterior segment
- •Any medical comorbidities except well controlled DH and HTN
- •Unable to follow up with study procedures as described
结局指标
主要结局
Normal Ocular Microbiome
时间窗: 3 years
Number of patients in middle Tennessee with a normal ocular microbiome by development of a normative database.
次要结局
- Whole Metagenome Sequencing Methods(3 years)