- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05604651
Comparison of Mucin Levels at the Ocular Surface of Visual Display Users With and Without Dry Eye Disease
November 20, 2022 updated by: Peking University Third Hospital
The study aimed to evaluate 1) if levels of the glycocalyx membrane mucins, including MUC1, MUC4, MUC16 and MUC20, are altered in conjunctival cells of visual display users With and Without Dry Eye Disease, and 2) if mucin levels correlate with dry eye clinical diagnostic data.
Study Overview
Detailed Description
The cross-sectional study aimed to evaluate 1) if levels of the glycocalyx membrane mucins, including MUC1, MUC4, MUC16 and MUC20, are altered in conjunctival cells of visual display users With and Without Dry Eye Disease, and 2) if mucin levels correlate with dry eye clinical diagnostic data.
Study Type
Observational
Enrollment (Actual)
94
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
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Beijing, China, 100191
- Peking University Third Hospital
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Video display terminals users with and without dry eye disease.
Description
Inclusion Criteria:
- Participants who exposed to video display terminals for more than 1 year (at least 5 days per week and 6 hours per day) were enrolled and divided into two groups: (1) VDT users with DED and (2) VDT users without DED. DED was diagnosed according to the Tear Film and Ocular Surface Society (TFOS) DEWS II criteria: (1) Ocular Surface Disease Index (OSDI) score ≥ 13 and (2) one of these signs; fluorescein tear breakup time (TBUT) <10 sec; abnormal ocular surface staining (>5 corneal spots or > 9 conjunctival spots).
Exclusion Criteria:
- a history of contact lens wear or ocular surgery within 2 year of the study visit; a history of previous ocular disease; topical or systemic therapies other than artificial tears within two weeks before recruitment; and inflammatory ocular diseases, ocular surface diseases, glaucoma and systemic diseases with ocular involvement, such as meibomian gland dysfunction, diabetes, and peripheral neuropathy.
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: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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dry eye disease
Dry eye disease was diagnosed according to the Tear Film and Ocular Surface Society (TFOS) DEWS II criteria: (1) Ocular Surface Disease Index (OSDI) score ≥ 13 and (2) one of these signs; fluorescein tear breakup time (TBUT) <10 sec; abnormal ocular surface staining (>5 corneal spots or > 9 conjunctival spots).
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no intervention
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control
The controll group enrolled healthy participants without ocular and systemic diseases.
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no intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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mucin expression
Time Frame: immediately after meeting the inclusion and exclusion criteria
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The mRNA expression of mucin was measured by Quantitative real-time PCR, which is a laboratory technique of molecular biology to find out how much of a specific section of DNA there is in a sample.
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immediately after meeting the inclusion and exclusion criteria
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hong Qi, PhD, Peking University Third Hospital
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)
March 1, 2021
Primary Completion (Actual)
September 2, 2021
Study Completion (Actual)
September 2, 2021
Study Registration Dates
First Submitted
October 29, 2022
First Submitted That Met QC Criteria
October 29, 2022
First Posted (Actual)
November 3, 2022
Study Record Updates
Last Update Posted (Actual)
November 23, 2022
Last Update Submitted That Met QC Criteria
November 20, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VDT
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.