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.

Study Overview

• Status: Completed
• Conditions: Meibomian Gland Dysfunction
• Intervention / Treatment: Drug: Treatment of Meibomian gland dysfunction

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Department of Ophthalmology, Yonsei Univeristy College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: moderate to severe meibomian gland dysfunction	Drug: Treatment of Meibomian gland dysfunction; artificial tears, 3% Diquafosol Tetrasodium eye drops, steroid eye drops, squeezing of meibomian glands, cleansing of eyelids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of tear-film lipid layer thickness after treatment of meibomian gland dysfunction		1 and 2 months after treatment of meibomian gland dysfunction
Changes of ocular aberration after treatment of meibomian gland dysfunction	ocular parameters measured by Ray-tracing wavefront aberrometers (i-Trace, Tracey technologies , Texas ,USA)	1 and 2 months after treatment of meibomian gland dysfunction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal erosion grade(oxford score)		1 and 2 months after treatment of meibomian gland dysfunction
OSDI(ocular surface disease index)		1 and 2 months after treatment of meibomian gland dysfunction
Meibomian gland abnormality	measured by physiological parameter (score 0,1,2,3,4)	1 and 2 months after treatment of meibomian gland dysfunction
Meibomian quality	measured by physiological parameter (score 0,1,2,3,4)	1 and 2 months after treatment of meibomian gland dysfunction
BUT(tear break-up time)		1 and 2 months after treatment of meibomian gland dysfunction

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• Asbell PA, Stapleton FJ, Wickstrom K, Akpek EK, Aragona P, Dana R, Lemp MA, Nichols KK. The international workshop on meibomian gland dysfunction: report of the clinical trials subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2065-85. doi: 10.1167/iovs.10-6997h. Print 2011 Mar. No abstract available.
• Geerling G, Tauber J, Baudouin C, Goto E, Matsumoto Y, O'Brien T, Rolando M, Tsubota K, Nichols KK. The international workshop on meibomian gland dysfunction: report of the subcommittee on management and treatment of meibomian gland dysfunction. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2050-64. doi: 10.1167/iovs.10-6997g. No abstract available.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2015
• Primary Completion (Actual): February 19, 2016
• Study Completion (Actual): February 19, 2016

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: November 27, 2015
• First Posted (Estimate): December 1, 2015

Study Record Updates

• Last Update Posted (Actual): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Meibomian gland dysfunction; Lipiview; Tear Lipid Layer
• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Meibomian Gland Dysfunction
• Other Study ID Numbers: 1-2015-0012