Evaluation of Factors Affecting the Tear-film Lipid Layer Thickness

Completed

• Conditions: Dry Eye Syndrome

• Registration Number: NCT02645045
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-11
• Study First Submitted: 2015-12-28
• Study First Submitted QC: 2015-12-30
• Study First Posted: 2016-01-01
• Primary Completion: 2016-02-10
• Study Completion: 2016-02-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1. age over 19 years old, Patients with dry eye syndrome and normal subjects

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tear Lipid Layer thickness measurement with a LipiView interferometer	1 day

Secondary Outcome Measures

Name	Time	Method
Corneal and conjunctival erosion grade(oxford score)	1 day
tear film break-up time (TBUT)	1 day
Ocular Surface Disease Index(OSDI) questionnaire	1 day
Schirmer's test (lacrimal secretion test)	1 day
tear meniscus height measurement using optical coherence tomography	1 day
evaluation of the score of lid margins and meibomian glands	1 day

Trial Locations

Locations (1)

Department of Ophthalmology, Yonsei Univeristy College of Medicine; 🇰🇷 Seoul, Korea, Republic of