Effect of Meibomian Gland Probing on Ocular Surface in Ocular Rosacea

Study Overview
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Brief Summary
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Meibomian glands (MG) are modified sebaceous glands associated with the tarsus (collagenous structural component) of the upper and lower eyelids. Meibomian glands produce lipid-based secretions which are an integral and stabilizing part of the tear film. In blepharitis and ocular rosacea (two known causes of obstructive meibomian gland dysfunction (o-MGD), inflammation of the lid margins causes blockage of the meibomian gland orifices, changes in glandular secretions, and dropout of the glands themselves. This limits the production, secretion, and quality of meibum. With less oil in the tear film, the aqueous portion of tears is not stable and evaporates quickly which leads to dry eye.

Detailed Description
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Meibomian gland probing is a relatively new, safe, and effective technique for treating obstructive meibomian gland dysfunction (o-MGD). It involves topical anesthesia of the eyelid margins and insertion of a 2 mm or 4 mm sterile, beveled, solid stainless steel probe at the slit lamp. Meibomian gland probing has been reported to alleviate symptoms (lid tenderness / lid margin congestion) of o-MGD (Maskin, 2010). It has also been shown to improve meibum lipid levels, viscosity, and tear breakup time (Nakayama, Kawashima, Kaido, Arita, & Tsubota, 2015). Though probing has been investigated in a few small studies of o-MGD, only one small study of 10 participants has investigated meibomian gland probing in ocular rosacea (Wladis, 2012). This study showed improvement in ocular surface disease index (OSDI, a standardized questionnaire assessing dry eye) but did not show objective improvement by way of examination findings or analysis of meibum (Wladis, 2012). In our study, Investigators intend to further investigate meibomian gland probing in participants with diagnosed ocular rosacea. Investigators hypothesize that after probing of one eye, Investigators will note improvements in participants symptoms as reflected in improvement in OSDI scores, Reductions in Inflamma-Dry measures (measure of matrix metalloproteinase (MMP-9), an inflammatory marker elevated in tears of participants with dry eye), decreased tear fluid osmolarity, decreased meibum viscosity on expression . Objective improvement in lid margin disease (noting collarettes, pitting, telangiectasia of lid margins, thickening / irregularity of lid margins, lid margin tenderness; improvement in tear break up time (TBUT); and improvement in corneal fluorescein / lissamine green staining).

Official Title
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Effect of Meibomian Gland Probing on Ocular Surface in Ocular Rosacea

Conditions
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Meibomian Gland Dysfunction

Intervention / Treatment
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* Procedure: meibomian gland probing
* Procedure: Left eye Meibomian Gland Probing Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Diagnosed Ocular Rosacea +/- Facial Rosacea Exclusion Criteria: Prior meibomian gland probing Prior treatment with Lipiflow Cicatricial Disease Sjogren's Syndrome Prior radiation therapy to face / head Allergy to lissamine green and fluorescein

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probing Treatment Right Eye<br>Meibomian gland will be performed on the right upper eye lid of each participant. | Procedure: meibomian gland probing<br>* Investigator will do baseline (OSDI) questionnaires prior to probing as well as at 1 week (at home), 1 month, 3months, and 6 months at office visits.<br>|
| Placebo Comparator: Fellow Eye (Left) Untreated<br>The fellow eye (left) will be used at the untreated control | Procedure: Left eye Meibomian Gland Probing Control Group<br>* There will be no probing in the left eye. This will be used as a control for the right eye.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvements in participants symptoms as reflected in improvement in Ocular Surface Disease Index (OSDI) scores | The OSDI is assessed on a scale of 0 and 100, with higher scores representing greater disability. | Up to 6 months |