Assessment of the Ocular Microbiome in Health and Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Eye swab
Other interventionThis is a simple swab under the eyelids of both eyes
Treatment groups
500 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Cohort A1 intervention
Group B: Cohort B1 intervention
Group C: Cohort C1 intervention
Group D: Cohort D1 intervention
Group E: Cohort E1 intervention
Group F: Cohort F1 intervention
Trial outcomes
Primary outcomes
1
Normal Ocular Microbiome
Number of patients in middle Tennessee with a normal ocular microbiome by development of a normative database.
Time frame
3 yearsSecondary outcomes
1
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.
Time frame
3 yearsOther outcomes
1
Novel Metatranscriptomics Analysis
Number of active microbial pathways and host epithelial gene expression profiles by novel metatranscriptomics analysis.
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov