NCT05414994

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Sep 2023Dec 2027

First Submitted

Initial submission to the registry

May 19, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 7, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

January 22, 2026

Status Verified

September 1, 2025

Enrollment Period

4.1 years

First QC Date

May 19, 2022

Last Update Submit

January 19, 2026

Conditions

Microbial ColonizationEye DiseasesOphthalmopathy

Outcome Measures

Primary Outcomes (1)

  • Normal Ocular Microbiome

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

    3 years

Secondary Outcomes (1)

  • Whole Metagenome Sequencing Methods

    3 years

Other Outcomes (1)

  • Novel Metatranscriptomics Analysis

    3 years

Study Arms (6)

Cohort A

normal eyes with no ocular disease

Other: Eye swab

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

Other: Eye swab

Cohort C

non-infectious keratopathy not using any prescription medication (OTC artificial tears are acceptable)

Other: Eye swab

Cohort D

Dry AMD (age related macular degeneration)

Other: Eye swab

Cohort E

Wet AMD

Other: Eye swab

Cohort F

diabetic retinopathy, any stage

Other: Eye swab

Interventions

Eye swabOTHER

This is a simple swab under the eyelids of both eyes

Cohort ACohort BCohort CCohort DCohort ECohort F

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We anticipate there will be approximately 20% failure rate due to the low bacterial load in these samples and so we will have to collect more samples to account for the loss of data. We estimate that 20 patients in each cohort of eyes with ocular disease - 100 total patients and 500 normal eyes will give us sufficient power to explore this topic.

You may qualify if:

  • We will include subjects who meet all of the following criteria:
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The inner eyelid of both eyelids will be swabbed

MeSH Terms

Conditions

Communicable DiseasesEye Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Havin Abdulkadir

CONTACT

6159361474havin.e.abdulkadir@vumc.org

Saige Priddy

CONTACT

saige.priddy@vumc.org

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 19, 2022

First Posted

June 10, 2022

Study Start

September 7, 2023

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

January 22, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)