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Completed

NCT Number: NCT02645045

Evaluation of Factors Affecting the Tear-film Lipid Layer Thickness

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.

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases Meibomian Gland Dysfunction

Age range

19 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, Yonsei Univeristy College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • Patients who used artificial tears were instructed not to apply them for at least 12 hours 99 before the examinations

Treatment and study plan

Primary outcomes

  1. Tear Lipid Layer thickness measurement with a LipiView interferometer

    Time frame: 1 day

Secondary outcomes

  1. tear meniscus height measurement using optical coherence tomography

    Time frame: 1 day

  2. Corneal and conjunctival erosion grade(oxford score)

    Time frame: 1 day

  3. tear film break-up time (TBUT)

    Time frame: 1 day

  4. Schirmer's test (lacrimal secretion test)

    Time frame: 1 day

  5. evaluation of the score of lid margins and meibomian glands

    Time frame: 1 day

  6. Ocular Surface Disease Index(OSDI) questionnaire

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 1, 2016
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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