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Confounding Factors in Ocular Surface Microbiome Research

Confounding Factors in Ocular Surface Microbiome Research

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04193917
Acronym
CoFa
Enrollment
450
Registered
2019-12-10
Start date
2019-11-24
Completion date
2024-01-23
Last updated
2024-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Surface Microbiome

Keywords

Ocular surface microbiome, Temporal stability, Confounding factors

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.

Interventions

DIAGNOSTIC_TESTConjunctival swab

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

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

A conjunctival swab will be taken from healthy volunteers

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Richness and evenness of distribution of the microbial flora measured as operational taxonomic units on a single moment20 minutes for samples and filling the questionnairesA conjunctival swab and extensive questionnaire will be taken to search for a core ocular surface microbiome and confounding factors
Change in richness and evenness of distribution of the microbial flora, measured as operational taxonomic units, over time20 minutes for the first sample and questionnaire, 5 minutes for all other visitsA conjunctival swab will be taken on different points in time to investigate the temporal stability of the conjunctival microbial flora

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026