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Assessment of the Ocular Microbiome in Health and Disease
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:
🦠 Microbial Colonization 🦠 Eye Diseases 🦠 Ophthalmopathy
🗓️ Study Start (Actual) 7 September 2023
🗓️ Primary Completion (Estimated) 30 September 2026
✅ Study Completion (Estimated) 30 December 2026
👥 Enrollment (Estimated) 500
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Nashville, Tennessee, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 19 May 2022
  • First Submitted that Met QC Criteria 7 June 2022
  • First Posted 10 June 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 September 2023
  • Last Update Posted 18 September 2023
  • Last Verified September 2023
I'm interested ...!!