Evaluation of Factors Affecting the Tear-film Lipid Layer Thickness

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02645045

Enrollment

350

Registered

2016-01-01

Start date

2015-12-11

Completion date

2016-02-10

Last updated

2017-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndrome

Keywords

Dry eye, Lipiview, Tear Lipid Layer, meibomian gland dysfunction

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.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

19 Years to 100 Years

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

Design outcomes

Primary

Measure	Time frame
Tear Lipid Layer thickness measurement with a LipiView interferometer	1 day

Secondary

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

Countries

South Korea

Outcome results