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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drop of artificial tears | Placebo Comparator | A drop op Thealoz duo |
|
| Drop op anesthetic | Active Comparator | A drop of oxybuprocaïne |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conjunctival swab | Diagnostic Test | Swab of the conjunctival fornices of both eyes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heleen Delbeke, MD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven, Department of Ophthalmology | Leuven | 3000 | Belgium |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 19, 2024 | |
| Reset | Jan 22, 2025 | |
| Release | Feb 11, 2025 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2021 |
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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.
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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.
| Oxybuprocaine Hydrochloride 0.4% Eye Drops | Drug | One drop of topical anesthesia in one eye |
|
|
| artificial tears | Drug | One drop of artificial tears in the other eye |
|
|
| Reset | Mar 4, 2025 |
| Release | Mar 11, 2025 |
| Reset | Mar 27, 2025 |
| Release | Apr 22, 2025 |
| Reset | May 8, 2025 |
| Release | May 27, 2025 |
| Reset | Jun 11, 2025 |
| Jul 18, 2022 |
| Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 19, 2024 | Jan 22, 2025 | |||
| Feb 11, 2025 | Mar 4, 2025 | |||
| Mar 11, 2025 | Mar 27, 2025 | |||
| Apr 22, 2025 | May 8, 2025 | |||
| May 27, 2025 | Jun 11, 2025 |
| ID | Term |
|---|---|
| C005298 | benoxinate |
| D009883 | Ophthalmic Solutions |
| D000777 | Anesthetics |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D002491 | Central Nervous System Agents |
| D054327 | Lubricants |
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