Tear Film SARS-nCoV-2 Detection in Symptomatic and Pauci-symptomatic Patients. (Eye-Covid)

December 17, 2024 updated by: Universitaire Ziekenhuizen KU Leuven

Tear Film SARS-nCoV-2 Detection in Symptomatic and Pauci-symptomatic

To investigate the presence of SARS-nCoV-2 in the tear film of symptomatic and pauci-symptomatic SARS-nCoV-2 positive patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The end goal of the study is to show whether or not the virus can be found in the tear film in both symptomatic and less symptomatic patients by means of serial sampling.

A sample of the tears / conjunctiva will be taken with a soft brush (similar to a cotton swab) every three days until the end of the hospitalization. In addition, you must complete a questionnaire that assesses the symptoms present.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

positive test for SARS-nCoV-2 on a nasopharyngeal swab.

Description

Inclusion Criteria:

  • Subject needs to be above 18 years old.
  • The subject is willing to undergo sampling of the conjunctiva.
  • The subject is willing to fill in a questionnaire.
  • The subject is fluent in written and verbal Dutch.
  • The subject is capable of giving informed consent.
  • Applicable for part 1 only: the subject test positive for SARS-nCoV-2 on a nasopharyngeal swab. The time window between a positive nasopharyngeal swab and the first conjunctival swab may be no more than 3 days.

Exclusion Criteria:

  • Allergy to Oxybuprocainehydrochloride
  • Pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
symptomatic patient
to confirm the detectability of the SARS-nCoV-2 in the tear film of symptomatic patients.
Diagnostic test: swabbing of conjunctiva
Each eye will be sampled with a single, sterile, nylon, flocked swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Presence of SARS-nCoV-2 in the Tear Film of Symptomatic and Pauci-symptomatic SARS-nCoV-2 Positive Patients.
Time Frame: during hospitalization every 3 days until the day of discharge up to 1 month
Bilateral conjunctival sampling will be performed on both eyes after the application of a drop of topical anesthesia at least once.
during hospitalization every 3 days until the day of discharge up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Delbeke Heleen, MD, UZ Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2020

Primary Completion (Actual)

December 13, 2020

Study Completion (Actual)

December 13, 2020

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S64002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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