Skip to main content
OpenTrials
Completed

NCT Number: NCT01683318

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Meibomian Gland Dysfunction (MGD) Eye Diseases Eyelid Diseases Meibomian Gland Dysfunction

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Singapore National Eye Centre

Singapore, 168751

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thermal Pulsation therapy

Procedure

Primary outcomes

  1. ocular discomfort

    Time frame: 3 months

Secondary outcomes

  1. Tear Break Up Time (TBUT)

    Time frame: 3 months

  2. Number of blocked meibomian glands

    Time frame: 3 months

  3. Corneal fluorescein staining score

    Time frame: 3 months

  4. 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.

  5. Tear evaporimetry

    Time frame: 3 months

  6. Lipid layer thickness

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Singapore National Eye Centre

Other Gov

Collaborators

  • National University of Singapore

Registry information

Official study title

Thermal Pulsation System for the Treatment of Meibomian Gland Dysfunction

Important dates

Study start
2012
Primary completion
2013
First posted
Sep 11, 2012
Registry last updated
Nov 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.