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The Ocular Microbiome in Patients With Dry Eye Disease

NCT ID: NCT04656197

Last Updated: 2020-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-30

Study Completion Date

2020-03-04

Brief Summary

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The primary objective of this study is the characterization of the ocular microbiome in a healthy cohort and in patients with dry eye disease using whole-metagenome shotgun sequencing. Secondary objectives are the identification of differences between the ocular microbiome of healthy controls and patients with dry eye disease as well as between the ocular and the gut microbiome.

Detailed Description

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Dry eye disease is considered to be the most common ocular surface disease worldwide. Recent studies revealed that the ocular microbiome plays an important role in maintaining ocular surface homeostasis and health. Commensals colonizing the ocular surface seem to support the local innate immune system. As the ocular microbiome coordinates several functions together with ocular mucosal and immune epithelial cells, alteration of the microbiome can lead to changes in the integrity of the ocular surface. This can lead to the development of ocular surface related diseases such as dry eye. Inflammation seems to be a key component of dry eye disease in terms of being a propagator as well as a consequence. In contrast to earlier approaches of identifying the microbiome by cultivating with only limited results, it is now possible to provide more details regarding all microbiota residing on the ocular surface due to modern sequencing techniques. Thus, the overall aim of this study is the identification of the role of the ocular microbiome in dry eye disease.

Conditions

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Dry Eye Disease

Keywords

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Ocular metagenome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with dry eye disease

Ocular microbiome

Intervention Type OTHER

Taxonomical and functional characterization of the ocular microbiome

Healthy controls

Ocular microbiome

Intervention Type OTHER

Taxonomical and functional characterization of the ocular microbiome

Interventions

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Ocular microbiome

Taxonomical and functional characterization of the ocular microbiome

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients willing to sign informed consent
* Patients 60 years of age or older

Exclusion Criteria

* Patients not willing or able to sign informed consent
* Patients younger than 60 years
* Smoking
* Wearing contact lenses
* Recent (3 month) history of use of systemic and/or topical antibiotics
* Usage of medical eye drops (Lacrycon and other moisturizing eye drops are allowed)
* Recent (3 month) history of ocular surgery
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Zinkernagel, Prof. Dr. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Inselspital, Bern

Locations

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Department of Ophthalmology, Inselspital

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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Zysset-Burri DC, Schlegel I, Lincke JB, Jaggi D, Keller I, Heller M, Lagache SB, Wolf S, Zinkernagel MS. Understanding the Interactions Between the Ocular Surface Microbiome and the Tear Proteome. Invest Ophthalmol Vis Sci. 2021 Aug 2;62(10):8. doi: 10.1167/iovs.62.10.8.

Reference Type DERIVED
PMID: 34369983 (View on PubMed)

Other Identifiers

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BASEC 2019-01670

Identifier Type: -

Identifier Source: org_study_id