Clinical trial NCT01683318: Treatment of Meibomian Gland Dysfunction
Official title: Thermal Pulsation System for the Treatment of Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meibomian Gland Dysfunction (MGD)
Lead sponsor: Singapore National Eye Centre
Sponsor class: OTHER_GOV
Collaborators: name: National University of Singapore
First posted: 2012-09-11
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. At least one out of 8 questions on dry eye symptoms is answered with often or all the time.
3. Eyes should not show any other ocular surface pathology which required more treatment than eye lubricant and conventional eyelid hygiene.

Exclusion Criteria:

1. Known history of thyroid disorders (diagnosed by physician).
2. No ocular surgery within the previous 6 months and LASIK within the previous 1 year.
3. Any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks.
4. Active ocular infection or pterygium.
5. Anticipated necessity to wear contact lens in the duration of the study.
6. Living in the same household as another participant of the study.
7. Any other specified reason as determined by clinical investigator, for example, the need to use any treatment or eyedrops not permitted by the study.

Primary outcomes:
measure: ocular discomfort
timeFrame: 3 months
Secondary outcomes:
measure: Tear Break Up Time (TBUT)
timeFrame: 3 months
measure: Number of blocked meibomian glands
timeFrame: 3 months
measure: Corneal fluorescein staining score
timeFrame: 3 months
measure: To measure the production of tears
timeFrame: 3 months
measure: Tear evaporimetry
timeFrame: 3 months
measure: Lipid layer thickness
timeFrame: 3 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore National Eye Centre
Study officials:
References:
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.