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

Meibomian Gland Dysfunction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02618304
• Other study ID #: 1-2015-0012
• Status: Completed
• Phase: N/A
• Start date: April 20, 2015
• Est. completion date: February 19, 2016

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 19, 2016
• Est. primary completion date: February 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

Drug:
• Treatment of Meibomian gland dysfunction
artificial tears, 3% Diquafosol Tetrasodium eye drops, steroid eye drops, squeezing of meibomian glands, cleansing of eyelids.

Locations

Country	Name	City	State
Korea, Republic of	Department of Ophthalmology, Yonsei Univeristy College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View Citation

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. — View Citation

McCulley JP, Shine WE. The lipid layer of tears: dependent on meibomian gland function. Exp Eye Res. 2004 Mar;78(3):361-5. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of tear-film lipid layer thickness after treatment of meibomian gland dysfunction		1 and 2 months after treatment of meibomian gland dysfunction
Primary	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	Corneal erosion grade(oxford score)		1 and 2 months after treatment of meibomian gland dysfunction
Secondary	OSDI(ocular surface disease index)		1 and 2 months after treatment of meibomian gland dysfunction
Secondary	Meibomian gland abnormality	measured by physiological parameter (score 0,1,2,3,4)	1 and 2 months after treatment of meibomian gland dysfunction
Secondary	Meibomian quality	measured by physiological parameter (score 0,1,2,3,4)	1 and 2 months after treatment of meibomian gland dysfunction
Secondary	BUT(tear break-up time)		1 and 2 months after treatment of meibomian gland dysfunction