Assessment of the Ocular Microbiome in Health and Disease

Microbial Colonization Clinical Trial

Official title:

Assessment of the Ocular Microbiome in Health and Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05414994
• Other study ID #: 10001
• Status: Recruiting
• Start date: September 7, 2023
• Est. completion date: December 30, 2026

Study information

• Verified date: September 2023
• Source: Vanderbilt University Medical Center
• Contact: Amber Wren
• Phone: 16153228920
• Email: amber.wren[@]vumc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Eye Diseases
• Infections
• Microbial Colonization
• Ophthalmopathy

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Novel Metatranscriptomics Analysis	Number of active microbial pathways and host epithelial gene expression profiles by novel metatranscriptomics analysis.	3 years
Primary	Normal Ocular Microbiome	Number of patients in middle Tennessee with a normal ocular microbiome by development of a normative database.	3 years
Secondary	Whole Metagenome Sequencing Methods	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.	3 years