Treatment of Meibomian Gland Dysfunction

Not Applicable

Completed

• Conditions: Meibomian Gland Dysfunction (MGD)
• Interventions: Procedure: Thermal Pulsation therapy

• Registration Number: NCT01683318
• Lead Sponsor: Singapore National Eye Centre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-09
• Study Start: 2012-09
• Study First Submitted: 2012-09-04
• Study First Submitted QC: 2012-09-10
• Study First Posted: 2012-09-11
• Primary Completion: 2013-10
• Last Update Submitted: 2013-11-11
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Thermal Pulsation therapy	Patients will undergo Thermal Pulsation treatment of Meibomian Gland Dysfunction using the TearScience System (Lipiflow).

Primary Outcome Measures

Name	Time	Method
ocular discomfort	3 months

Secondary Outcome Measures

Name	Time	Method
Tear Break Up Time (TBUT)	3 months
Number of blocked meibomian glands	3 months
Corneal fluorescein staining score	3 months
To measure the production of tears	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	3 months
Lipid layer thickness	3 months

Trial Locations

Locations (1)

Singapore National Eye Centre; 🇸🇬 Singapore, Singapore