Confounding Factors in Ocular Surface Microbiome Research

Confounding Factors in Ocular Surface Microbiome Research

Sponsors

Lead Sponsor: Universitaire Ziekenhuizen Leuven

Source Universitaire Ziekenhuizen 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.

Overall Status Recruiting
Start Date November 24, 2019
Completion Date May 30, 2021
Primary Completion Date May 30, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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
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
Enrollment 500
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: Conjunctival swab

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

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Heleen Delbeke, MD Principal Investigator Universitaire Ziekenhuizen Leuven
Overall Contact

Last Name: Heleen Delbeke, MD

Phone: 0016346228

Email: [email protected]

Location
Facility: Status: Contact: University Hospitals Leuven, Department of Ophthalmology Heleen Delbeke, MD [email protected]
Location Countries

Belgium

Verification Date

December 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Acronym CoFa
Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: A conjunctival swab will be taken from healthy volunteers

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov