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

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT04193774
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
28.4
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Conjunctival swab
  • Drug: Oxybuprocaine Hydrochloride 0.4% Eye Drops
  • Drug: artificial tears
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
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.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.
Masking:
Double (Care Provider, Investigator)
Masking Description:
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.
Primary Purpose:
Diagnostic
Official Title:
Optimization of Sampling for Molecular Microbial Research on Ocular Surface Samples and Building a Framework for Comparing Current Sequencing Results Using Different Extraction Protocols.
Actual Study Start Date :
Aug 19, 2019
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Drop of artificial tears

A drop op Thealoz duo

Diagnostic Test: Conjunctival swab
Swab of the conjunctival fornices of both eyes

Drug: artificial tears
One drop of artificial tears in the other eye
Other Names:
  • Thealoz duo

    		•
    Active Comparator: Drop op anesthetic

    A drop of oxybuprocaïne

    Diagnostic Test: Conjunctival swab
    Swab of the conjunctival fornices of both eyes

    Drug: Oxybuprocaine Hydrochloride 0.4% Eye Drops
    One drop of topical anesthesia in one eye
    Other Names:
  • anesthetic

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Difference in richness of the microbial flora measured as operational taxonomic units [5 minutes per sampling session]

      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.

    2. Difference in evenness of distribution of the microbial flora measured as operational taxonomic units [5 minutes per sampling session]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospitals Leuven, Department of Ophthalmology Leuven Belgium 3000

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven

    Investigators

    • Principal Investigator: Heleen Delbeke, MD, Universitaire Ziekenhuizen Leuven

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT04193774
    Other Study ID Numbers:
    • S62672
    First Posted:
    Dec 10, 2019
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Universitaire Ziekenhuizen Leuven
    Ocular surface microbiome
    Anesthesia
    Extraction protocol
    Additional relevant MeSH terms:
    Anesthetics
    Benoxinate
    Ophthalmic Solutions
    Lubricant Eye Drops

    Study Results

    No Results Posted as of Jul 22, 2022