Optimization of Sampling and Processing of Samples for Molecular Microbial Research on Ocular Surface Samples

NCT04193774 | Completed

• 1 other identifier: S62672
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The use of anesthetics and the processing of the retrieved samples are major confounding factors that influence the results of microbiome research.

Conditions

Microbiota; Ocular Surface

Keywords

Ocular surface microbiome; Anesthesia; Extraction protocol

Outcome Measures

Primary Outcomes (2)

• Difference in richness of the microbial flora measured as operational taxonomic units

  The difference in richness and evenness of distribution of the microbial flora of samples retrieved after a drop of topical anesthesia versus samples retrieved after a drop of artificial tears.

  5 minutes per sampling session

• Difference in evenness of distribution of the microbial flora measured as operational taxonomic units

  The effect of the different microbial DNA extraction protocols on the richness and evenness of distribution of the microbial flora of the ocular surface will be compared.

  5 minutes per sampling session

Study Arms (2)

Drop of artificial tears

PLACEBO COMPARATOR

A drop op Thealoz duo

Diagnostic Test: Conjunctival swab; Drug: artificial tears

Drop op anesthetic

ACTIVE COMPARATOR

A drop of oxybuprocaïne

Diagnostic Test: Conjunctival swab; Drug: Oxybuprocaine Hydrochloride 0.4% Eye Drops

Interventions

Conjunctival swab DIAGNOSTIC_TEST

Swab of the conjunctival fornices of both eyes

Drop of artificial tears; Drop op anesthetic

Oxybuprocaine Hydrochloride 0.4% Eye Drops DRUG

One drop of topical anesthesia in one eye

Also known as: anesthetic

Drop op anesthetic

artificial tears DRUG

One drop of artificial tears in the other eye

Also known as: Thealoz duo

Drop of artificial tears

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to undergo sampling of the conjunctiva
• Fluent in written and verbal Dutch
• Capable of giving informed consent

You may not qualify if:

• Allergy to oxybuprocaine
• Medication usage in one eye only

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven, Department of Ophthalmology

Leuven, 3000, Belgium

Location

MeSH Terms

Interventions

benoxinate; Ophthalmic Solutions; Anesthetics; Lubricant Eye Drops

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Central Nervous System Depressants; Physiological Effects of Drugs; Central Nervous System Agents; Lubricants

Study Officials

• Heleen Delbeke, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The nurse application the drops receives a closed envelope wherein the information about which eye receives what type of drop is included. The executor is blinded.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: When the patient is under general anesthesia for another reason, he or she receives a drop of artificial tears in one eye and a drop of anesthetic in the other eye in a randomized way.

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 10, 2019
• Study Start: August 19, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)