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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02618304
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arm: 1
• Actual Duration (Months): 10
• Patients Per Site Per Month: 4.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Meibomian Gland Dysfunction	Drug: Treatment of Meibomian gland dysfunction	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Start Date: Apr 20, 2015
• Actual Primary Completion Date: Feb 19, 2016
• Actual Study Completion Date: Feb 19, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Changes of tear-film lipid layer thickness after treatment of meibomian gland dysfunction [1 and 2 months after treatment of meibomian gland dysfunction]

2. Changes of ocular aberration after treatment of meibomian gland dysfunction [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 Outcome Measures

1. Corneal erosion grade(oxford score) [1 and 2 months after treatment of meibomian gland dysfunction]

2. OSDI(ocular surface disease index) [1 and 2 months after treatment of meibomian gland dysfunction]

3. Meibomian gland abnormality [1 and 2 months after treatment of meibomian gland dysfunction]

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

4. Meibomian quality [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) [1 and 2 months after treatment of meibomian gland dysfunction]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Ophthalmology, Yonsei Univeristy College of Medicine	Seoul		Korea, Republic of	03722

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Asbell PA, Stapleton FJ, Wickström 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. Review.
• 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. Review.
• McCulley JP, Shine WE. The lipid layer of tears: dependent on meibomian gland function. Exp Eye Res. 2004 Mar;78(3):361-5. Review.
• 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. Review.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02618304
• Other Study ID Numbers: 1-2015-0012
• First Posted: Dec 1, 2015
• Last Update Posted: Jan 10, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by Yonsei University: Meibomian gland dysfunction; Lipiview; Tear Lipid Layer
• Additional relevant MeSH terms: Meibomian Gland Dysfunction

Study Results

No Results Posted as of Jan 10, 2019