Treatment of Meibomian Gland Dysfunction
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:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Thermal Pulsation System for the Treatment of Meibomian Gland Dysfunction|
- ocular discomfort [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Tear Break Up Time (TBUT) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Number of blocked meibomian glands [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Corneal fluorescein staining score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- To measure the production of tears [ Time Frame: 3 months ] [ Designated as safety issue: No ]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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Lipid layer thickness [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2012|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Patients will undergo Thermal Pulsation treatment of Meibomian Gland Dysfunction using the TearScience System (Lipiflow).
|Procedure: Thermal Pulsation therapy|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683318
|Singapore National Eye Centre|
|Singapore, Singapore, 168751|