Recruiting

Ocular Microbiome

Sponsor:

Vanderbilt University Medical Center

Code:

NCT05414994

Conditions

Microbial Colonization

Eye Diseases

Ophthalmopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Eye swab

Study Details

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.

Conditions

Microbial Colonization

Eye Diseases

Ophthalmopathy

Study ID

NCT05414994

Start date

Sep 7, 2023

Status verified date

Sep, 2025

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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, any stage

Interventions

Eye swab

This is a simple swab under the eyelids of both eyes

Primary outcome measure

  • Normal Ocular Microbiome [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Havin Abdulkadir

6159361474havin.e.abdulkadir@vumc.org

Saige Priddy

saige.priddy@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Jan 22, 2026

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-01-22.