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Completed

NCT Number: NCT02618304

Changes of Tear-film Lipid Layer Thickness and Ocular Aberration After Treatment of Meibomian Gland Dysfunction

In this study, investigator aim to evaluate the changes of tear-film lipid layer thickness and ocular aberration after treatment of meibomian gland dysfunction. In case of stage 3 or 4 meibomian gland dysfunction, participants will be treated using conventional treatment modalities. Before treatment and after 1 and 2 months of treatment, a variety of ophthalmic examination, tear-film lipid layer thickness, and ocular aberration are going to measured and compared.

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Key information

Conditions

Meibomian Gland Dysfunction Eye Diseases Eyelid Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, Yonsei Univeristy College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age over 19 years old, with moderate to severe Meibomian gland dysfunction.

Exclusion criteria

  • patients with history of previous ocular or intraocular surgery
  • ocular infection, non dry eye ocular inflammation, ocular allergy, autoimmune disease
  • history of intolerance or hypersensitivity to any component of the study medications
  • wearing contact lenses during the study period, presence of current punctal occlusion
  • pregnancy, lactating women, and children

Treatment and study plan

Treatment of Meibomian gland dysfunction

Drug

artificial tears, 3% Diquafosol Tetrasodium eye drops, steroid eye drops, squeezing of meibomian glands, cleansing of eyelids.

Primary outcomes

  1. Changes of tear-film lipid layer thickness after treatment of meibomian gland dysfunction

    Time frame: 1 and 2 months after treatment of meibomian gland dysfunction

  2. Changes of ocular aberration after treatment of meibomian gland dysfunction

    Time frame: 1 and 2 months after treatment of meibomian gland dysfunction

    ocular parameters measured by Ray-tracing wavefront aberrometers (i-Trace, Tracey technologies , Texas ,USA)

Secondary outcomes

  1. Corneal erosion grade(oxford score)

    Time frame: 1 and 2 months after treatment of meibomian gland dysfunction

  2. OSDI(ocular surface disease index)

    Time frame: 1 and 2 months after treatment of meibomian gland dysfunction

  3. Meibomian gland abnormality

    Time frame: 1 and 2 months after treatment of meibomian gland dysfunction

    measured by physiological parameter (score 0,1,2,3,4)

  4. Meibomian quality

    Time frame: 1 and 2 months after treatment of meibomian gland dysfunction

    measured by physiological parameter (score 0,1,2,3,4)

  5. BUT(tear break-up time)

    Time frame: 1 and 2 months after treatment of meibomian gland dysfunction

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 1, 2015
Registry last updated
Jan 10, 2019

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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