Ocular Microbiome Biorepository to Evaluate Ocular Microbiome in Health and Disease

• Sponsor: Vanderbilt University Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05414994
• Collaborator: (none)
• Enrollment: 140
• Location: 1
• Anticipated Duration (Months): 23.4
• Patients Per Site Per Month: 6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Microbial Colonization; Eye Diseases; Ophthalmopathy

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 140 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Ocular Microbiome Biorepository to Evaluate Ocular Microbiome in Health and Disease
• Actual Study Start Date: Jul 20, 2022
• Anticipated Primary Completion Date: Jun 30, 2024
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
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
Cohort G maculopathy

Outcome Measures

Primary Outcome Measures

1. Normal Ocular Microbiome [2 years]

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

Secondary Outcome Measures

1. Whole Metagenome Sequencing Methods [2 years]

   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.

Other Outcome Measures

1. Novel Metatranscriptomics Analysis [2 years]

   Number of active microbial pathways and host epithelial gene expression profiles by novel metatranscriptomics analysis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

• Cohort G - maculopathy

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

• Vanderbilt University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sapna Gangaputra, Assistant Professor, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT05414994
• Other Study ID Numbers: 10001
• First Posted: Jun 10, 2022
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Communicable Diseases; Infections; Eye Diseases

Study Results

No Results Posted as of Jul 28, 2022