Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Cohort A normal eyes with no ocular disease
  • Other: Eye swab
    This is a simple swab under the eyelids of both eyes
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
    This is a simple swab under the eyelids of both eyes
Cohort C non-infectious keratopathy not using any prescription medication (OTC artificial tears are acceptable)
  • Other: Eye swab
    This is a simple swab under the eyelids of both eyes
Cohort D Dry AMD (age related macular degeneration)
  • Other: Eye swab
    This is a simple swab under the eyelids of both eyes
Cohort E Wet AMD
  • Other: Eye swab
    This is a simple swab under the eyelids of both eyes
Cohort F diabetic retinopathy, any stage
  • Other: Eye swab
    This is a simple swab under the eyelids of both eyes

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Sapna Gangaputra, M.D.

More Details

Status
Recruiting
Sponsor
Vanderbilt University Medical Center

Study Contact

saige Wilkins
6159361474
saige.wilkins@vumc.org

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.