Eyelid Warming Technology for Meibomian Gland Dysfunction
Condition: Meibomian Gland Dysfunction
MeSH terms: Meibomian Gland Dysfunction
Study type: Interventional

Summary: 
      Meibomian gland dysfunction (MGD), an extremely common clinical condition (seen in more than
      half of some Asian populations), affects the lipid producing meibomian glands in the eyelids.
      One function of the glandular secretions is to reduce evaporation of the tear film. In MGD
      the meibomian glands may become blocked for various reasons. The consequential retention and
      stasis of the secretion increases immune response as well as scarring response. This
      eventually results in an abnormal tear film and dry eye symptoms.

      The current standard treatments include warm moist compresses, regular lid hygiene, oral
      antibiotics, topical antibiotic ointments and Omega 3 supplementation. Heating for an
      extended duration is important because it relieves the occlusion of blocked meibomian glands.
      However, improvised methods of heating are cumbersome and inefficient requiring repeated
      measures, often leading to lack of compliance. Today, there is a wider range of commercially
      available devices that help to unblock meibomian glands and relief dry eye symptoms. These
      devices may improve MGD treatment dramatically, but have not been tested in the warm climate
      of Singapore, and are not readily available.

      The current study aims to test the efficacy of treatment for devices that utilize A) warm
      moisture (Blephasteam) and B) warmth (EyeGiene) in patients suffering from meibomian gland
      dysfunction. Patients will be asked to use Blephasteam and EyeGiene for a period of 4 weeks.
      The study will monitor patients for changes in tear film and lipid composition, as well as
      changes in the anatomy of meibomian glands. Additionally, dry eye symptoms will be documented
      in form of questionnaires. If the newer methods of managing MGD are found to be efficacious
      and safe, these treatment measures can be made available to patients in Singapore.
    

Detailed description: 
      Study Objectives and Purpose:

        1. A primary purpose of the study is to compare the efficacy of novel eyelid warming
           devices (Blephasteam and EyeGiene) for treatment of meibomian gland dysfunction by
           objective clinical scoring and objective assessment of ocular surface parameters in an
           Asian population.

        2. The second aim is to assess the patient acceptance of these modalities, in terms of
           comfort and convenience.

        3. A third aim of the study is to document Meibomian gland disease using non-invasive
           Meibography, and the possible alterations of this condition after treatment.

      Study Design: Prospective, controlled, single masked, interventional study

      Rationale:

      Meibomian gland dysfunction and resulting evaporative dry eye is highly common in our general
      population. Behavioral factors and environmental stress may contribute to the severity of the
      disease. Eyelid warming devices have the potential to significantly improve meibomian gland
      health and alleviate dry eye symptoms associated with the disease. Currently eyelid warming
      devices suitable for treatment of meibomian gland dysfunction are not available in Singapore.

      Recent technological advances, as well as the infrastructure of the Singapore Eye Research
      Institute (proximity to Singapore National Eye Center and pre-existing facility and
      infrastructure for clinical trials) have facilitated studies of products that are available
      elsewhere and may benefit the Singaporean population.

      Methods:

      Participants and target sample size Seventy-five patients from the dry eye clinic in the
      Singapore National Eye Center who have obstructive meibomian gland dysfunction and are keen
      to test alternative ways for treating the disease will be selected.

      Randomisation is done by randomisation table as deemed appropriate by the statistician
      collaborator.

      Treatment regime After informed written consent, patients will be randomly assigned to a
      group.

        1. Control group, 10-minute treatment, twice daily

        2. Blephasteam, 10-minute treatment, twice daily

        3. EyeGiene, 10-minute treatment, twice daily

      All patients are permitted to continue their regular management of MGD such as use of lid
      scrubs or lid hygiene preparations (such as Lidcare and Blephagel). For consistency, the
      investigators will monitor the use of such measures in a daily diary and prohibit any other
      types of treatment for MGD such as Omega-3 tablets, antibiotic or steroid ointments, probing
      of MG.

      Visit schedules Screening visit will be performed at the regular dry eye clinic. If eligible,
      patients will sign consent and undergo baseline examination.

      Subsequent to this, the follow up visit will be after 4 weeks of treatment. A window period
      of

      +/-3days is permitted for this visit.

      Duration of study:

      Four weeks.
    

Intervention name(s): Blephasteam; EyeGiene; Hot compresses
Intervention type(s): Device; Device; Device
Intervention description(s): 10 minute treatment twice daily; 10 minute treatment, twice daily; 10 minute treatment, twice daily
Other intervention name(s): Spectrum Théa, France; Eyedetec Medical Inc., US
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: meibomian gland dysfunction; hot compress; eyelid warming; meibum