Evaluation of Factors Affecting the Tear-film Lipid Layer Thickness

Dry Eye Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02645045
• Other study ID #: 4-2015-1009
• Status: Completed
• Phase: N/A
• First received: December 28, 2015
• Last updated: January 24, 2017
• Start date: December 11, 2015
• Est. completion date: February 10, 2016

Study information

• Verified date: January 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: February 10, 2016
• Est. primary completion date: February 10, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Locations

Country	Name	City	State
Korea, Republic of	Department of Ophthalmology, Yonsei Univeristy College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Hom MM, Martinson JR, Knapp LL, Paugh JR. Prevalence of Meibomian gland dysfunction. Optom Vis Sci. 1990 Sep;67(9):710-2. — View Citation

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. Review. — View Citation

McCulley JP, Shine WE. The lipid layer of tears: dependent on meibomian gland function. Exp Eye Res. 2004 Mar;78(3):361-5. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear Lipid Layer thickness measurement with a LipiView interferometer		1 day
Secondary	tear meniscus height measurement using optical coherence tomography		1 day
Secondary	Corneal and conjunctival erosion grade(oxford score)		1 day
Secondary	tear film break-up time (TBUT)		1 day
Secondary	Schirmer's test (lacrimal secretion test)		1 day
Secondary	evaluation of the score of lid margins and meibomian glands		1 day
Secondary	Ocular Surface Disease Index(OSDI) questionnaire		1 day