Treatment of Meibomian Gland Dysfunction

This study has been completed.
Sponsor:
Collaborator:
National University, Singapore
Information provided by (Responsible Party):
Louis Tong, Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT01683318
First received: September 4, 2012
Last updated: November 11, 2013
Last verified: September 2012
  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: 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

Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:
  • ocular discomfort [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683318

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

No publications provided

Responsible Party: Louis Tong, Clinician-Scientist, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT01683318     History of Changes
Other Study ID Numbers: R913/22/2012
Study First Received: September 4, 2012
Last Updated: November 11, 2013
Health Authority: Singapore: Health Sciences Authority

ClinicalTrials.gov processed this record on July 28, 2014