MicrobiotaEPSONCT04193774
Optimization of Sampling and Processing of Samples for Molecular Microbial Research on Ocular Surface Samples
A study testing Conjunctival swab, Oxybuprocaine Hydrochloride 0.4% Eye Drops and artificial tears in people with Microbiota and Ocular Surface, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The use of anesthetics and the processing of the retrieved samples are major confounding factors that influence the results of microbiome research. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microbiota, Ocular Surface
- What is being tested?
- Conjunctival swab, Oxybuprocaine Hydrochloride 0.4% Eye Drops and artificial tears
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Aug 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to undergo sampling of the conjunctiva
- Fluent in written and verbal Dutch
- Capable of giving informed consent
Who cannot join
- Allergy to oxybuprocaine
- Medication usage in one eye only
Trial locations and contacts
1 site in 1 country.
Belgium1 site
University Hospitals Leuven, Department of Ophthalmology
Leuven, 3000
About this study
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.
The use of anesthetics and the processing of the retrieved samples are major confounding factors that influence the results of microbiome research.
Read the 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.
- Conditions
- Microbiota, Ocular Surface
- Being tested
- Conjunctival swab, Oxybuprocaine Hydrochloride 0.4% Eye Drops, artificial tears
- Keywords
- Ocular surface microbiome, Anesthesia, Extraction protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conjunctival swabDiagnostic test
Swab of the conjunctival fornices of both eyes
Oxybuprocaine Hydrochloride 0.4% Eye DropsDrug
Also called anesthetic
One drop of topical anesthesia in one eye
artificial tearsDrug
Also called Thealoz duo
One drop of artificial tears in the other eye
| Study group | Role | What they receive |
|---|---|---|
| Drop of artificial tears | Placebo comparator | A drop op Thealoz duo Receives: Diagnostic Test: Conjunctival swab; Drug: artificial tears |
| Drop op anesthetic | Active comparator | A drop of oxybuprocaïne Receives: Diagnostic Test: Conjunctival swab; Drug: Oxybuprocaine Hydrochloride 0.4% Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 minutes per sampling session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start19 Aug 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiotaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heleen Delbeke, MD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193774
- Sponsor's protocol ID
- S62672
- Acronym
- EPSO
- Status last verified
- Jun 2022
- First submitted
- 4 Dec 2019
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04193774
- Acronym / sponsor ID
- EPSO / S62672
- Conditions
- Microbiota, Ocular Surface
- Keywords
- Ocular surface microbiome, Anesthesia, Extraction protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of anesthetics and the processing of the retrieved samples are major confounding factors that influence the results of microbiome research.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Drop of artificial tears | Placebo comparator | Diagnostic Test: Conjunctival swab, Drug: artificial tearsA drop op Thealoz duo |
| Drop op anesthetic | Active comparator | Diagnostic Test: Conjunctival swab, Drug: Oxybuprocaine Hydrochloride 0.4% Eye DropsA drop of oxybuprocaïne |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to undergo sampling of the conjunctiva
- Fluent in written and verbal Dutch
- Capable of giving informed consent
Key exclusion criteria (2 listed)
- Allergy to oxybuprocaine
- Medication usage in one eye only
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conjunctival swabSwab of the conjunctival fornices of both eyes | Diagnostic test | Drop of artificial tears, Drop op anesthetic |
| Oxybuprocaine Hydrochloride 0.4% Eye DropsAlso: anestheticOne drop of topical anesthesia in one eye | Drug | Drop op anesthetic |
| artificial tearsAlso: Thealoz duoOne drop of artificial tears in the other eye | Drug | Drop of artificial tears |
Primary outcome
Difference in richness of the microbial flora measured as operational taxonomic units
Time frame: 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.
Difference in evenness of distribution of the microbial flora measured as operational taxonomic units
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heleen Delbeke, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conjunctival swab, Oxybuprocaine Hydrochloride 0.4% Eye Drops and artificial tears in people with Microbiota and Ocular Surface, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in richness of the microbial flora measured as operational taxonomic units (time frame: 5 minutes per sampling session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.