NCT05414994

Assessment of the Ocular Microbiome in Health and Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Microbial Colonization
• Eye Diseases
• Ophthalmopathy

Interventions

Type	Name	Description
OTHER	Eye swab	This is a simple swab under the eyelids of both eyes

Timeline

• Start date: 2023-09-07
• Primary completion: 2027-09-30
• Completion: 2027-12-30
• First posted: 2022-06-10
• Last updated: 2026-01-22

Locations

1 site across 1 country: United States