Dry Eye Clinical Trial
Official title:
Pilot Study to Examine Efficacy and Cytokines Levels After Meibomian Gland Expression (MGX) With and Without Intense Pulsed Light Treatment (IPL)
Dry eye disease (DED) is a common condition that causes ocular discomfort and reduces visual
acuity. The two categories of DED are evaporative dry eye and aqueous deficient dry eye. Both
conditions can involve pathology of the meibomian glands, lacrimal glands, lids, tear film
and surface cells. Meibomian gland dysfunction (MGD) is the leading cause of evaporative dry
eye and contributes to aqueous deficient dry eye. The goal of MGD therapy is to provide long
term improvement of symptoms for patients by improving the quality of meibum, increasing
meibum flow, improving tear film stability and decreasing inflammation.
Commonly used therapies include preservative free drops, omega-3 fatty acid supplementation,
topical cyclosporine, serum tears, topical azithromycin, oral doxycycline, moisture chambers,
intraductal probing, lib margin exfoliation, automated thermal pulsation, warm compresses,
among other. Despite this variety of symptoms, patients often do not experience complete or
long term relief of symptoms.
Forced meibomian gland expression (MGX) has been shown to be an effective method of
rehabilitating meibomian glands and improving dry eye symptoms. The eyelid margins are
forcefully compressed to express gland contents. Research has shown improvement in patient
symptoms with the use of MGX.
Intense pulsed light (IPL) have been used in dermatology to treat various conditions.
Patients with DED who have tried other therapies and found no relief, often resort to IPL as
a last resort. Research has shown IPL alone may be effective in improving patient symptoms.
In addition, such studies have failed to show significant adverse events with the use of IPL.
Here, we propose a prospective, randomized, case controlled clinical pilot study to examine
the efficacy for both subjective and objective measures. 20 patients with DED will be
recruited and will be randomly assigned to one of two groups: MGX alone or MGX with IPL.
Objective measures will include tear cytokine levels, impression cytology, meibography, tear
osmolarity and others. Subjective measures will include quality of life screening tools.
We hypothesize that the use of MGX with IPL will lead to greater improvement in subjective
dry eye symptoms and objective measures. Given the lack of adverse effects reported in the
literature, we do not anticipate adverse effects in our study.
Rochester staff Drs. Faustch and Bourne are providing clinical research advice but have no
contact with subjects or biospecimens.
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