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NCT Number: NCT05414994

Assessment of the Ocular Microbiome in Health and Disease

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location status: Recruiting

Location contact

Sapna Gangaputra, M.D.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eye swab

Other

This is a simple swab under the eyelids of both eyes

Primary outcomes

  1. Normal Ocular Microbiome

    Time frame: 3 years

    Number of patients in middle Tennessee with a normal ocular microbiome by development of a normative database.

Secondary outcomes

  1. Whole Metagenome Sequencing Methods

    Time frame: 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.

Other outcomes

  1. Novel Metatranscriptomics Analysis

    Time frame: 3 years

    Number of active microbial pathways and host epithelial gene expression profiles by novel metatranscriptomics analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Havin Abdulkadir

CONTACT

[email protected]

6159361474

Saige Priddy

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2022
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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