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Confounding Factors in Ocular Surface Microbiome Research

NCT ID: NCT04193917

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-24

Study Completion Date

2024-01-23

Brief Summary

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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

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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.

Conditions

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Ocular Surface Microbiome

Keywords

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Ocular surface microbiome Temporal stability Confounding factors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A conjunctival swab will be taken from healthy volunteers
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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conjunctival swab

A conjunctival swab of both eyes will be taken

Group Type OTHER

Conjunctival swab

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Conjunctival swab

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heleen Delbeke, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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University Hospitals Leuven, Department of Ophthalmology

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S63155

Identifier Type: -

Identifier Source: org_study_id