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

U

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Conditions

Ocular Surface
Microbiota

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

24 participants in 2 patient groups, including a placebo group

Drop of artificial tears
Placebo Comparator group
Description:
A drop op Thealoz duo
Treatment:
Diagnostic Test: Conjunctival swab
Drug: artificial tears
Drop op anesthetic
Active Comparator group
Description:
A drop of oxybuprocaïne
Treatment:
Diagnostic Test: Conjunctival swab
Drug: Oxybuprocaine Hydrochloride 0.4% Eye Drops

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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