Effect of Meibomian Gland Probing on Ocular Surface in Ocular Rosacea

Meibomian Gland Dysfunction Clinical Trial

Official title:

Effect of Meibomian Gland Probing on Ocular Surface in Ocular Rosacea

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02735681
• Other study ID #: 205144
• Status: Withdrawn
• Phase: N/A
• First received: March 29, 2016
• Last updated: April 24, 2018
• Start date: February 1, 2017
• Est. completion date: March 28, 2018

Study information

• Verified date: April 2018
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 28, 2018
• Est. primary completion date: March 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction
• Rosacea

Intervention

Procedure:
• meibomian gland probing
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.
• Left eye Meibomian Gland Probing Control Group
There will be no probing in the left eye. This will be used as a control for the right eye.

Locations

Country	Name	City	State
United States	Jones Eye Institute, UAMS	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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