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NCT05604651 Clinical Trial

Comparison of Mucin Levels at the Ocular Surface of Visual Display Users With and Without Dry Eye Disease

Dry Eye Disease Clinical Trial

Official title:
Comparison of Mucin Levels at the Ocular Surface of Visual Display Users With and Without Dry Eye Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05604651
Other study ID # VDT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date September 2, 2021

Study information
Verified date October 2022
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 94
Est. completion date September 2, 2021
Est. primary completion date September 2, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• no intervention
no intervention

Locations
Country Name City State
China Peking University Third Hospital Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary mucin expression 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. immediately after meeting the inclusion and exclusion criteria
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