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

Microbiota Clinical Trial

— EPSO  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04193774
• Other study ID #: S62672
• Status: Completed
• Phase: N/A
• Start date: August 19, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2022
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Microbiota
• Ocular Surface

Intervention

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
• artificial tears
One drop of artificial tears in the other eye

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven, Department of Ophthalmology	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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