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Clinical Trials/NCT04193917
NCT04193917
Completed
Not Applicable

Confounding Factors in Ocular Surface Microbiome Research

Universitaire Ziekenhuizen KU Leuven1 site in 1 country450 target enrollmentNovember 24, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ocular Surface Microbiome
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
450
Locations
1
Primary Endpoint
Change in richness and evenness of distribution of the microbial flora, measured as operational taxonomic units, over time
Status
Completed
Last Updated
last year

Overview

Brief Summary

To elucidate confounding factors in ocular surface microbiome research and to confirm the presence of a core ocular surface microbiome and its temporal stability.

Detailed Description

The investigator will take a conjunctival sample of both eyes of a group of volunteers together with an extensive questionnaire. Furthermore, 50 volunteers will be sampled repeatedly during one year or two years.

Registry
clinicaltrials.gov
Start Date
November 24, 2019
End Date
January 23, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • The subject is fluent in written and verbal Dutch
  • The subject is capable of giving informed consent

Exclusion Criteria

  • Use of glaucoma drops
  • Use of antibiotic drops \< 1 month before sampling

Outcomes

Primary Outcomes

Change in richness and evenness of distribution of the microbial flora, measured as operational taxonomic units, over time

Time Frame: 20 minutes for the first sample and questionnaire, 5 minutes for all other visits

A conjunctival swab will be taken on different points in time to investigate the temporal stability of the conjunctival microbial flora

Richness and evenness of distribution of the microbial flora measured as operational taxonomic units on a single moment

Time Frame: 20 minutes for samples and filling the questionnaires

A conjunctival swab and extensive questionnaire will be taken to search for a core ocular surface microbiome and confounding factors

Study Sites (1)

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