NCT03987178|Completed
Microbiologic Alterations of the Conjunctiva of Hot Tub-soaking Ophthalmologists
MACHO
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MACHO
Sponsor study identifier
interventional
36
1 country
1
Study Start
May 27, 2019
Actual (reported)Primary Completion
March 26, 2020
Actual (reported)Study Completion
March 26, 2020
Actual (reported)The purpose of this study is to determine if there are microbiologic alterations of the ocular surface after hot tub exposure. The study will evaluate the number of microbes before and after hot tub use in order to find out whether hot tub exposure has any change on the organisms present on the ocular surface. Participants will be randomized to dunk or not to dunk their head during their time in the hot tub.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 26, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 27, 2019
Actual (reported)June 5, 2019
Actual (reported)June 14, 2019
Actual (reported)March 26, 2020
Actual (reported)March 26, 2020
Actual (reported)Quantity of organisms
Genus-species will be identified for each sample, and quantified with an ordinal scale (0-4). The total of this score will be the quantity for that person-time. The primary analyses will be a Wilcoxon Rank Sum test (Mann-Whitney) between the two arms at the follow-up time point (randomized comparison of dunk vs no-dunk), and a Wilcoxon Signed Rank test between pre-hot-tub and post-hot-tub (longitudinal comparison of all cases). We estimate that a total of 20 subjects will provide 80% power to detect a 1.25 SD difference in the total quantity score between randomization arms at the post (f/u) time point. We estimate 80% power to detect a .9 SD difference between pre (baseline) and post (f/u) time points in a paired longitudinal analysis.
1 year
Richness (number of species per sample) of organisms found in the conjunctiva with hot tub use (post-test comparison)
1 year
Richness (number of species per sample) of organisms found in the conjunctiva with hot tub use (pre versus post)
1 year
Difference in organism profile with hot tub use (pre versus post)
1 year
Difference in organism profile with hot tub use (between arms)
1 year
Quantity comparing pre-hot tub and post-hot tub swabs
1 year
Subjects who are assigned to be in this arm are asked to sit in a hot tub for 15 minutes and instructed to submerge his or her head in the hot tub at least once and at least up to the eyebrows during his or her time in the hot tub.
Subjects assigned to this arm are asked to sit in a hot tub for 15 minutes but to keep his or her chin above water during the entire time.
If randomized to "Dunk," the subject is asked to submerge his or her head in the hot tub at least up to brow level.
Subjects will be asked to sit in a hot tub for 15 minutes (with an individual timer).
UCSF
San Francisco, California, 94122, United States
Gerami D Seitzman, MD
UCSF/Proctor Foundation
36 participants (actual enrollment reported by the registry).
First Submitted
June 5, 2019
First Posted
June 14, 2019
Study Start
May 27, 2019
Systemic Pharmacokinetics of BOL-303224-A
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
March 26, 2020
Actual (reported)Study Completion
March 26, 2020
Actual (reported)Last Updated
September 10, 2020
Record last verified: 2020-09
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Source: ClinicalTrials.gov.
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