Clinical trial NCT02735681: Effect of Meibomian Gland Probing on Ocular Surface in Ocular Rosacea
Official title: Effect of Meibomian Gland Probing on Ocular Surface in Ocular Rosacea
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Meibomian Gland Dysfunction
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Improvements in participants symptoms as reflected in improvement in Ocular Surface Disease Index (OSDI) scores
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Jones Eye Institute, UAMS
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Sunali Goyal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arkansas
name: Joshua Hardin, MD
role: PRINCIPAL_INVESTIGATOR
References: