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Effect of Meibomian Gland Probing on Ocular Surface in Ocular Rosacea

Not Applicable
Withdrawn
Conditions
Meibomian Gland Dysfunction
Interventions
Procedure: Left eye Meibomian Gland Probing Control Group
Procedure: meibomian gland probing
Registration Number
NCT02735681
Lead Sponsor
University of Arkansas
Brief Summary

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

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).

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Fellow Eye (Left) UntreatedLeft eye Meibomian Gland Probing Control GroupThe fellow eye (left) will be used at the untreated control
Probing Treatment Right Eyemeibomian gland probingMeibomian gland will be performed on the right upper eye lid of each participant.
Primary Outcome Measures
NameTimeMethod
Improvements in participants symptoms as reflected in improvement in Ocular Surface Disease Index (OSDI) scoresUp to 6 months

The OSDI is assessed on a scale of 0 and 100, with higher scores representing greater disability.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Jones Eye Institute, UAMS

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Little Rock, Arkansas, United States

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