NCT03987178

Microbiologic Alterations of the Conjunctiva of Hot Tub-soaking Ophthalmologists

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Keratitis is a rare destructive cause of blindness. It typically affects young and healthy individuals, is excruciatingly painful, and difficult to treat. With 60% of cases mis-diagnosed at presentation, acanthamoeba keratitis carries a far worse visual prognosis compared to other cornea infections. Exposure to hot tubs is a widely accepted risk factor. However, the mechanism of infection and prediction of who is at risk is unknown as the vast majority of hot tub users do not become infected.In vivo changes to ocular microbiology after hot tub exposure has never been described. Changes to ocular microbiology after exposure to hot tubs have not been described. The purpose of this study is to investigate whether there are significant alterations in the microbiology of the conjunctiva after hot tub exposure that may contribute to these changes. This study will recruit at least 34 subjects, who will be randomized to head submersion versus no head submersion, using at least three different hot tubs. A conjunctival swab, a minimal-risk test performed routinely in the eye clinic, will be performed before and after 15 minutes of hot tub exposure on one eye (randomized) per subject. The swabs will be plated on blood agar (bacterial cultures) and non-nutrient agar (acanthamoeba cultures). In this prospective study, healthy subjects will be recruited. The study will be Health Insurance Portability and Accountability Act compliant and approved by the Institutional Review Board. All subjects will review and sign an informed consent form. Each patient will have the conjunctiva of one eye (randomized) cultured. This practically no-risk technique entails touching a polyester-tip swab to the lining of the lower eyelid. Each subject will be randomized to head submersion or no head submersion; this exposure will be masked by the study coordinator. After 15 minutes of hot tub exposure, the subject will have the same eye swabbed for cultures. Each sample (pre- and post-hot tub) will be randomly assigned a study number. One study coordinator will record and mask data. Water from each tub will be cultured. The culture plates will be sent to our microbiology facility at UCSF and identification of organisms on the blood agar plates will be performed on our MALDI (mass spectrometry to identify bacteria and fungi). Non-nutrient agar plates will be plated with E. coli overlay and incubated for up to 7 days. The plates will be randomized and the microbiologists will be masked to exposures.

Conditions

• Conjunctivitis, Bacterial
• Keratitis Bacterial

Interventions

Type	Name	Description
BEHAVIORAL	Dunk	If randomized to "Dunk," the subject is asked to submerge his or her head in the hot tub at least up to brow level.
OTHER	Exposure to Hot Tub	Subjects will be asked to sit in a hot tub for 15 minutes (with an individual timer).

Timeline

• Start date: 2019-05-27
• Primary completion: 2020-03-26
• Completion: 2020-03-26
• First posted: 2019-06-14
• Last updated: 2020-09-10

Locations

1 site across 1 country: United States