Treatment of Meibomian Gland Dysfunction
Primary Purpose
Meibomian Gland Dysfunction (MGD)
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Thermal Pulsation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Meibomian Gland Dysfunction (MGD)
Eligibility Criteria
Inclusion Criteria:
- Eyelids must present with blocked meibomian gland openings (plugs), at least 1 visible MG plug in the 4 eyelids, or discernable change in consistency of meibum (increased in viscosity or opacity) when MG expressed in upper or lower eyelids.
- At least one out of 8 questions on dry eye symptoms is answered with often or all the time.
- Eyes should not show any other ocular surface pathology which required more treatment than eye lubricant and conventional eyelid hygiene.
Exclusion Criteria:
- Known history of thyroid disorders (diagnosed by physician).
- No ocular surgery within the previous 6 months and LASIK within the previous 1 year.
- Any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks.
- Active ocular infection or pterygium.
- Anticipated necessity to wear contact lens in the duration of the study.
- Living in the same household as another participant of the study.
- Any other specified reason as determined by clinical investigator, for example, the need to use any treatment or eyedrops not permitted by the study.
Sites / Locations
- Singapore National Eye Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Patients will undergo Thermal Pulsation treatment of Meibomian Gland Dysfunction using the TearScience System (Lipiflow).
Outcomes
Primary Outcome Measures
ocular discomfort
Secondary Outcome Measures
Tear Break Up Time (TBUT)
Number of blocked meibomian glands
Corneal fluorescein staining score
To measure the production of tears
Schirmer's test uses paper strips inserted into the lower eyelid (conjunctival sac)for 5 minutes to measure the production of tears. Both eyes are tested at the same time. The paper is then removed and the amount of moisture is measured.
Tear evaporimetry
Lipid layer thickness
Full Information
NCT ID
NCT01683318
First Posted
September 4, 2012
Last Updated
November 11, 2013
Sponsor
Singapore National Eye Centre
Collaborators
National University of Singapore
1. Study Identification
Unique Protocol Identification Number
NCT01683318
Brief Title
Treatment of Meibomian Gland Dysfunction
Official Title
Thermal Pulsation System for the Treatment of Meibomian Gland Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Singapore National Eye Centre
Collaborators
National University of Singapore
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The current study aims to test the efficacy of treatment for a device that utilises a thermal pulsation system, which applies heat from the inner surface of the eyelids (Lipiflow) in patients suffering from meibomian gland dysfunction.
Patients will be asked to undergo a one-time treatment with Lipiflow and the investigators will monitor them for changes in tear film and lipid composition, as well as changes in the anatomy of meibomian glands for over a study period of 12 weeks. Additionally, dry eye symptoms will be documented in form of questionnaires.
The investigators hypothesize that the treatment will be effective in improving clinical signs and will relieve dry eye symptoms for the patient. If this method of managing Meibomian Gland Dysfunction (MGD) is found to be efficacious and safe, it will be made available to patients in Singapore.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction (MGD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients will undergo Thermal Pulsation treatment of Meibomian Gland Dysfunction using the TearScience System (Lipiflow).
Intervention Type
Procedure
Intervention Name(s)
Thermal Pulsation therapy
Primary Outcome Measure Information:
Title
ocular discomfort
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Tear Break Up Time (TBUT)
Time Frame
3 months
Title
Number of blocked meibomian glands
Time Frame
3 months
Title
Corneal fluorescein staining score
Time Frame
3 months
Title
To measure the production of tears
Description
Schirmer's test uses paper strips inserted into the lower eyelid (conjunctival sac)for 5 minutes to measure the production of tears. Both eyes are tested at the same time. The paper is then removed and the amount of moisture is measured.
Time Frame
3 months
Title
Tear evaporimetry
Time Frame
3 months
Title
Lipid layer thickness
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eyelids must present with blocked meibomian gland openings (plugs), at least 1 visible MG plug in the 4 eyelids, or discernable change in consistency of meibum (increased in viscosity or opacity) when MG expressed in upper or lower eyelids.
At least one out of 8 questions on dry eye symptoms is answered with often or all the time.
Eyes should not show any other ocular surface pathology which required more treatment than eye lubricant and conventional eyelid hygiene.
Exclusion Criteria:
Known history of thyroid disorders (diagnosed by physician).
No ocular surgery within the previous 6 months and LASIK within the previous 1 year.
Any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks.
Active ocular infection or pterygium.
Anticipated necessity to wear contact lens in the duration of the study.
Living in the same household as another participant of the study.
Any other specified reason as determined by clinical investigator, for example, the need to use any treatment or eyedrops not permitted by the study.
Facility Information:
Facility Name
Singapore National Eye Centre
City
Singapore
ZIP/Postal Code
168751
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
27096755
Citation
Yeo S, Tan JH, Acharya UR, Sudarshan VK, Tong L. Longitudinal Changes in Tear Evaporation Rates After Eyelid Warming Therapies in Meibomian Gland Dysfunction. Invest Ophthalmol Vis Sci. 2016 Apr 1;57(4):1974-81. doi: 10.1167/iovs.16-19088.
Results Reference
derived
Learn more about this trial
Treatment of Meibomian Gland Dysfunction
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