Evaluation of Factors Affecting the Tear-film Lipid Layer Thickness

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT02645045
Collaborator
(none)
350
1
2
174.6

Study Details

Study Description

Brief Summary

In this study, the investigators aim to determine the effects of age, sex, history of ocular surgery and contact lens use, and ocular surface and meibomian gland parameters on the lipid layer thickness (LLT) in normal subjects and patients with dry eye syndrome. Patients with dry eye syndrome and subjects with a healthy ocular surface will be enrolled. All participant will underwent LLT measurement with a LipiView interferometer, tear meniscus height measurement using optical coherence tomography, tear film break-up time (TBUT) determination, corneal and conjunctival staining, Schirmer's test, examination of the lid margins and meibomian glands, and assessment using the Ocular Surface Disease Index(OSDI) questionnaire.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    350 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Cross-Sectional
    Actual Study Start Date :
    Dec 11, 2015
    Actual Primary Completion Date :
    Feb 10, 2016
    Actual Study Completion Date :
    Feb 10, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Dry eye

    Patients with dry eye syndrome

    normal

    Patients without dry eye

    Outcome Measures

    Primary Outcome Measures

    1. Tear Lipid Layer thickness measurement with a LipiView interferometer [1 day]

    Secondary Outcome Measures

    1. tear meniscus height measurement using optical coherence tomography [1 day]

    2. Corneal and conjunctival erosion grade(oxford score) [1 day]

    3. tear film break-up time (TBUT) [1 day]

    4. Schirmer's test (lacrimal secretion test) [1 day]

    5. evaluation of the score of lid margins and meibomian glands [1 day]

    6. Ocular Surface Disease Index(OSDI) questionnaire [1 day]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. age over 19 years old, Patients with dry eye syndrome and normal subjects
    Exclusion Criteria:
    1. patients less than 18 years of age and patients with histories of ocular surgery within 3 months; ocular injury; and ocular diseases such as ocular infection, allergy, and autoimmune disease; and patients with the use of a punctal plug or topical ocular medications other than artificial tears.

    2. Patients who used artificial tears were instructed not to apply them for at least 12 hours 99 before the examinations

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Ophthalmology, Yonsei Univeristy College of Medicine Seoul Korea, Republic of 03722

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT02645045
    Other Study ID Numbers:
    • 4-2015-1009
    First Posted:
    Jan 1, 2016
    Last Update Posted:
    Jan 25, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Yonsei University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 25, 2017