Clinical trial NCT02645045: Evaluation of Factors Affecting the Tear-film Lipid Layer Thickness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndrome
Keywords: Dry eye
Lipiview
Tear Lipid Layer
meibomian gland dysfunction
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-01-01
Enrollment: 350
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: age over 19 years old, Patients with dry eye syndrome and normal subjects

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.


Eligibility criteria: 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

Primary outcomes:
measure: Tear Lipid Layer thickness measurement with a LipiView interferometer
timeFrame: 1 day
Secondary outcomes:
measure: tear meniscus height measurement using optical coherence tomography
timeFrame: 1 day
measure: Corneal and conjunctival erosion grade(oxford score)
timeFrame: 1 day
measure: tear film break-up time (TBUT)
timeFrame: 1 day
measure: Schirmer's test (lacrimal secretion test)
timeFrame: 1 day
measure: evaluation of the score of lid margins and meibomian glands
timeFrame: 1 day
measure: Ocular Surface Disease Index(OSDI) questionnaire
timeFrame: 1 day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Ophthalmology, Yonsei Univeristy College of Medicine
Study officials:
References:
citation: 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.
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. Print 2011 Mar. No abstract available.
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. Print 2011 Mar. No abstract available.
citation: 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.