Treatment of Meibomian Gland Dysfunction

Thermal Pulsation System for the 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.

Study Overview

• Status: Completed
• Conditions: Meibomian Gland Dysfunction (MGD)
• Intervention / Treatment: Procedure: Thermal Pulsation therapy

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 168751
    • Singapore National Eye Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Patients will undergo Thermal Pulsation treatment of Meibomian Gland Dysfunction using the TearScience System (Lipiflow).	Procedure: Thermal Pulsation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ocular discomfort	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	3 months
Tear evaporimetry		3 months
Lipid layer thickness		3 months

Collaborators and Investigators

• Sponsor: Singapore National Eye Centre
• Collaborators: National University, Singapore

Publications and helpful links

General Publications

• Yeo S, Tan JH, Acharya UR, Sudarshan VK, Tong L. Longitudinal Changes in Tear Evaporation Rates After Eyelid Warming Therapies in Meibomian Gland Dysfunction. Invest Ophthalmol Vis Sci. 2016 Apr 1;57(4):1974-81. doi: 10.1167/iovs.16-19088.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: September 4, 2012
• First Submitted That Met QC Criteria: September 10, 2012
• First Posted (Estimate): September 11, 2012

Study Record Updates

• Last Update Posted (Estimate): November 13, 2013
• Last Update Submitted That Met QC Criteria: November 11, 2013
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Meibomian Gland Dysfunction
• Other Study ID Numbers: R913/22/2012