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Treatment of Meibomian Gland Dysfunction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01683318
First Posted: September 11, 2012
Last Update Posted: November 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National University, Singapore
Information provided by (Responsible Party):
Louis Tong, Singapore National Eye Centre
  Purpose

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 Intervention
Meibomian Gland Dysfunction (MGD) Procedure: Thermal Pulsation therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thermal Pulsation System for the Treatment of Meibomian Gland Dysfunction

Resource links provided by NLM:


Further study details as provided by Louis Tong, Singapore National Eye Centre:

Primary Outcome Measures:
  • ocular discomfort [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 25
Study Start Date: September 2012
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Patients will undergo Thermal Pulsation treatment of Meibomian Gland Dysfunction using the TearScience System (Lipiflow).
Procedure: Thermal Pulsation therapy

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Singapore
Singapore National Eye Centre
Singapore, Singapore, 168751
Sponsors and Collaborators
Singapore National Eye Centre
National University, Singapore
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Louis Tong, Clinician-Scientist, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT01683318     History of Changes
Other Study ID Numbers: R913/22/2012
First Submitted: September 4, 2012
First Posted: September 11, 2012
Last Update Posted: November 13, 2013
Last Verified: September 2012