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OpenTrials
Completed

NCT Number: NCT04193917

Confounding Factors in Ocular Surface Microbiome Research

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

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Key information

Conditions

Ocular Surface Microbiome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven, Department of Ophthalmology

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conjunctival swab

Diagnostic Test

A conjunctival swab of both eyes will be taken at the same time together with an extensive questionnaire.

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: CoFa

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Dec 10, 2019
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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