Back to resultsChanges of Tear-film Lipid Layer Thickness and Ocular Aberration After Treatment of Meibomian Gland Dysfunction
Primary Purpose
Meibomian Gland Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Treatment of Meibomian gland dysfunction
Sponsored by
About this trial
This is an interventional treatment trial for Meibomian Gland Dysfunction focused on measuring Meibomian gland dysfunction, Lipiview, Tear Lipid Layer
Eligibility Criteria
Inclusion Criteria:
1. 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
Sites / Locations
- Department of Ophthalmology, Yonsei Univeristy College of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
moderate to severe meibomian gland dysfunction
Arm Description
Outcomes
Primary Outcome Measures
Changes of tear-film lipid layer thickness 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)
Secondary Outcome Measures
Corneal erosion grade(oxford score)
OSDI(ocular surface disease index)
Meibomian gland abnormality
measured by physiological parameter (score 0,1,2,3,4)
Meibomian quality
measured by physiological parameter (score 0,1,2,3,4)
BUT(tear break-up time)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02618304
Brief Title
Changes of Tear-film Lipid Layer Thickness and Ocular Aberration After Treatment of Meibomian Gland Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 20, 2015 (Actual)
Primary Completion Date
February 19, 2016 (Actual)
Study Completion Date
February 19, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction
Keywords
Meibomian gland dysfunction, Lipiview, Tear Lipid Layer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
moderate to severe meibomian gland dysfunction
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Treatment of Meibomian gland dysfunction
Intervention Description
artificial tears, 3% Diquafosol Tetrasodium eye drops, steroid eye drops, squeezing of meibomian glands, cleansing of eyelids.
Primary Outcome Measure Information:
Title
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
Title
Changes of ocular aberration after treatment of meibomian gland dysfunction
Description
ocular parameters measured by Ray-tracing wavefront aberrometers (i-Trace, Tracey technologies , Texas ,USA)
Time Frame
1 and 2 months after treatment of meibomian gland dysfunction
Secondary Outcome Measure Information:
Title
Corneal erosion grade(oxford score)
Time Frame
1 and 2 months after treatment of meibomian gland dysfunction
Title
OSDI(ocular surface disease index)
Time Frame
1 and 2 months after treatment of meibomian gland dysfunction
Title
Meibomian gland abnormality
Description
measured by physiological parameter (score 0,1,2,3,4)
Time Frame
1 and 2 months after treatment of meibomian gland dysfunction
Title
Meibomian quality
Description
measured by physiological parameter (score 0,1,2,3,4)
Time Frame
1 and 2 months after treatment of meibomian gland dysfunction
Title
BUT(tear break-up time)
Time Frame
1 and 2 months after treatment of meibomian gland dysfunction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. 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
Facility Information:
Facility Name
Department of Ophthalmology, Yonsei Univeristy College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
21450920
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.
Results Reference
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PubMed Identifier
21450919
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.
Results Reference
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PubMed Identifier
21450918
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.
Results Reference
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PubMed Identifier
15106913
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.
Results Reference
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Changes of Tear-film Lipid Layer Thickness and Ocular Aberration After Treatment of Meibomian Gland Dysfunction
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