Assessment of the Ocular Microbiome in Health and Disease

Recruiting

• Conditions: Ophthalmopathy; Eye Diseases; Microbial Colonization
• Interventions: Other: Eye swab

• Registration Number: NCT05414994
• Lead Sponsor: Vanderbilt University Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2022-05-19
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-10
• Status Verified: 2023-09
• Study Start: 2023-09-07
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-18
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort D	Eye swab	Dry AMD (age related macular degeneration)
Cohort E	Eye swab	Wet AMD
Cohort F	Eye swab	diabetic retinopathy, any stage
Cohort A	Eye swab	normal eyes with no ocular disease
Cohort B	Eye swab	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	Eye swab	non-infectious keratopathy not using any prescription medication (OTC artificial tears are acceptable)

Primary Outcome Measures

Name	Time	Method
Normal Ocular Microbiome	3 years	Number of patients in middle Tennessee with a normal ocular microbiome by development of a normative database.

Secondary Outcome Measures

Name	Time	Method
Whole Metagenome Sequencing Methods	3 years	Number of ocular microbial species in different age and ethnic groups by the development of whole metagenome sequencing methods optimized for low biomass samples to characterize the ocular surface (anterior segment) microbiome.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States