Evaluation of Factors Affecting the Tear-film Lipid Layer Thickness

NCT ID: NCT02645045

Last Updated: 2017-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-11

Study Completion Date

2016-02-10

Brief Summary

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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

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Conditions

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Dry Eye Syndrome

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Dry eye

Patients with dry eye syndrome

No interventions assigned to this group

normal

Patients without dry eye

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Ophthalmology, Yonsei Univeristy College of Medicine

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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Hom MM, Martinson JR, Knapp LL, Paugh JR. Prevalence of Meibomian gland dysfunction. Optom Vis Sci. 1990 Sep;67(9):710-2. doi: 10.1097/00006324-199009000-00010.

Reference Type BACKGROUND
PMID: 2234831 (View on PubMed)

Knop E, Knop N, Millar T, Obata H, Sullivan DA. The international workshop on meibomian gland dysfunction: report of the subcommittee on anatomy, physiology, and pathophysiology of the meibomian gland. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1938-78. doi: 10.1167/iovs.10-6997c. Print 2011 Mar. No abstract available.

Reference Type BACKGROUND
PMID: 21450915 (View on PubMed)

Tomlinson A, Bron AJ, Korb DR, Amano S, Paugh JR, Pearce EI, Yee R, Yokoi N, Arita R, Dogru M. The international workshop on meibomian gland dysfunction: report of the diagnosis subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2006-49. doi: 10.1167/iovs.10-6997f. Print 2011 Mar. No abstract available.

Reference Type BACKGROUND
PMID: 21450918 (View on PubMed)

McCulley JP, Shine WE. The lipid layer of tears: dependent on meibomian gland function. Exp Eye Res. 2004 Mar;78(3):361-5. doi: 10.1016/s0014-4835(03)00203-3.

Reference Type BACKGROUND
PMID: 15106913 (View on PubMed)

Other Identifiers

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4-2015-1009

Identifier Type: -

Identifier Source: org_study_id

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