Treatment of Meibomian Gland Dysfunction
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|ClinicalTrials.gov Identifier: NCT01683318|
Recruitment Status : Completed
First Posted : September 11, 2012
Last Update Posted : November 13, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Meibomian Gland Dysfunction (MGD)||Procedure: Thermal Pulsation therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Thermal Pulsation System for the Treatment of Meibomian Gland Dysfunction|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||October 2013|
Patients will undergo Thermal Pulsation treatment of Meibomian Gland Dysfunction using the TearScience System (Lipiflow).
Procedure: Thermal Pulsation therapy
- ocular discomfort [ Time Frame: 3 months ]
- Tear Break Up Time (TBUT) [ Time Frame: 3 months ]
- Number of blocked meibomian glands [ Time Frame: 3 months ]
- Corneal fluorescein staining score [ Time Frame: 3 months ]
- To measure the production of tears [ Time Frame: 3 months ]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 ]
- Lipid layer thickness [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683318
|Singapore National Eye Centre|
|Singapore, Singapore, 168751|