Exploring the Ocular Microbiome in Health and Disease
Assessment of the Ocular Microbiome in Health and Disease
This study is trying to understand the tiny germs on the eye's surface to see how they affect eye health and diseases like glaucoma and diabetic retinopathy in adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05414994 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize the ocular surface microbiome and understand its role in eye health and disease. It will involve a prospective cohort of adults, analyzing factors that influence microbial colonization and the microbiome's impact on conditions like glaucoma, age-related macular degeneration, and diabetic retinopathy. Participants will undergo eye swab procedures to collect samples for advanced microbiome analysis using techniques such as 16S rRNA sequencing and metagenomics. The study seeks to fill the gap in knowledge regarding the ocular microbiome and its potential protective functions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with specific eye conditions such as glaucoma, age-related macular degeneration, or those with normal eyes.
Not a fit: Patients with prior ocular diseases or significant medical comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of various eye diseases through microbiome-targeted therapies.
How similar studies have performed: While there is emerging literature on the ocular microbiome, this study represents a novel approach to understanding its role in eye health and disease.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Havin Abdulkadir
- Email: havin.e.abdulkadir@vumc.org
- Phone: 6159361474
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.