Skip to content

Assessment of the Ocular Microbiome in Health and Disease

Assessment of the Ocular Microbiome in Health and Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05414994
Enrollment
500
Registered
2022-06-10
Start date
2023-09-07
Completion date
2027-12-30
Last updated
2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Diseases, Microbial Colonization, Ophthalmopathy

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.

Interventions

OTHEREye swab

This is a simple swab under the eyelids of both eyes

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Normal Ocular Microbiome3 yearsNumber of patients in middle Tennessee with a normal ocular microbiome by development of a normative database.

Secondary

MeasureTime frameDescription
Whole Metagenome Sequencing Methods3 yearsNumber 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.

Countries

United States

Contacts

CONTACTHavin Abdulkadir
havin.e.abdulkadir@vumc.org6159361474
CONTACTSaige Priddy
saige.priddy@vumc.org

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026