Clinical trial NCT02618304: Changes of Tear-film Lipid Layer Thickness and Ocular Aberration After Treatment of Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meibomian Gland Dysfunction
Keywords: Meibomian gland dysfunction
Lipiview
Tear Lipid Layer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 45
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes of tear-film lipid layer thickness after treatment of meibomian gland dysfunction
timeFrame: 1 and 2 months after treatment of meibomian gland dysfunction
measure: Changes of ocular aberration after treatment of meibomian gland dysfunction
timeFrame: 1 and 2 months after treatment of meibomian gland dysfunction
Secondary outcomes:
measure: Corneal erosion grade(oxford score)
timeFrame: 1 and 2 months after treatment of meibomian gland dysfunction
measure: OSDI(ocular surface disease index)
timeFrame: 1 and 2 months after treatment of meibomian gland dysfunction
measure: Meibomian gland abnormality
timeFrame: 1 and 2 months after treatment of meibomian gland dysfunction
measure: Meibomian quality
timeFrame: 1 and 2 months after treatment of meibomian gland dysfunction
measure: BUT(tear break-up time)
timeFrame: 1 and 2 months after treatment of meibomian gland dysfunction
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Ophthalmology, Yonsei Univeristy College of Medicine
Study officials:
References:
citation: 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.
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. No abstract available.
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. No abstract available.
citation: 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.