Thermal Pulsation System for the Treatment of Meibomian Gland Dysfunction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- ocular discomfort
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
ocular discomfort
Time Frame: 3 months
Secondary Outcomes
- Tear Break Up Time (TBUT)(3 months)
- Number of blocked meibomian glands(3 months)
- Corneal fluorescein staining score(3 months)
- To measure the production of tears(3 months)
- Tear evaporimetry(3 months)
- Lipid layer thickness(3 months)
Investigators
Louis Tong
Clinician-Scientist
Singapore National Eye Centre