Confounding Factors in Ocular Surface Microbiome Research

Not Applicable

Completed

• Conditions: Ocular Surface Microbiome

• Registration Number: NCT04193917
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study Start: 2019-11-24
• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-06
• Study First Posted: 2019-12-10
• Primary Completion: 2024-01-23
• Study Completion: 2024-01-23
• Status Verified: 2024-07
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospitals Leuven, Department of Ophthalmology; 🇧🇪 Leuven, Belgium