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

NCT ID: NCT04193774

Last Updated: 2022-07-22

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-19

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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The use of anesthetics is subject of discussion in ocular surface microbiome research. One publication showed a significant lower alpha diversity when using an anesthetic. However, the diluting effect of the anesthetic drop itself was not accounted for. On the other hand, using anesthetics will enable patients to tolerate sampling better and this might allow better sampling. To analyze the effect of anesthetic drops on the composition of the ocular surface microbiome, we sampled volunteers undergoing general anesthesia. By using artificial tears as a control, we aimed at accounting for the diluting effect of the anesthetic. By using volunteers under general anesthesia, we wanted to assure similar pressure with or without topical anesthesia since the executor was not influenced by the patient's reaction.

Furthermore, the effect of different extraction protocols on sequencing results will be assessed by sampling different volunteers in both eyes on non consecutive days.

Conditions

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Microbiota Ocular Surface

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Caregivers Investigators
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.

Study Groups

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Drop of artificial tears

A drop op Thealoz duo

Group Type PLACEBO_COMPARATOR

Conjunctival swab

Intervention Type DIAGNOSTIC_TEST

Swab of the conjunctival fornices of both eyes

artificial tears

Intervention Type DRUG

One drop of artificial tears in the other eye

Drop op anesthetic

A drop of oxybuprocaïne

Group Type ACTIVE_COMPARATOR

Conjunctival swab

Intervention Type DIAGNOSTIC_TEST

Swab of the conjunctival fornices of both eyes

Oxybuprocaine Hydrochloride 0.4% Eye Drops

Intervention Type DRUG

One drop of topical anesthesia in one eye

Interventions

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Conjunctival swab

Swab of the conjunctival fornices of both eyes

Intervention Type DIAGNOSTIC_TEST

Oxybuprocaine Hydrochloride 0.4% Eye Drops

One drop of topical anesthesia in one eye

Intervention Type DRUG

artificial tears

One drop of artificial tears in the other eye

Intervention Type DRUG

Other Intervention Names

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anesthetic Thealoz duo

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Allergy to oxybuprocaine
* Medication usage in one eye only
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

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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S62672

Identifier Type: -

Identifier Source: org_study_id

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