Microbial Colonization Clinical Trial
Official title:
Assessment of the Ocular Microbiome in Health and Disease
NCT number | NCT05414994 |
Other study ID # | 10001 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 7, 2023 |
Est. completion date | December 30, 2026 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
United States,
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 |
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