Dry eye syndrome is a common eye disease that affects 1 to 2 out of 10 persons around the planet. One common cause of this disease is the meibomian gland dysfunction. Meibomian glands are very small glands located at the rim of the eyelids that produce an oily substance that prevents the evaporation of tears. When these glands are compromised, the tear film evaporates quickly and the eyes dry up. This disease presents as eye irritation, foreign body sensation, inflammation, etc. The treatment of choice for MGD is eyelid massage and warm compresses 2 times a day. However, these treatments not always work perfectly, and as a result, patients find it hard to follow doctor's orders. Another kind of treatment is thermal therapy. There are several devices that are designed to apply heat on the eyelids, such as Lipiflow, MiBo Thermoflo, and Blephasteam. In this study, we want to find out whether thermal therapy with MiBo Thermoflo works better than warm compresses and eyelid massage use in the treatment of dry eye caused by MGD. To do this, we will select several patients and will assign them randomly to either the group with thermal therapy with MiBo Thermoflo or to the group with warm compresses and eyelid massage. The Mibo group will receive 3 sessions of thermal therapy at 2 weeks interval and the control group warm compresses and eyelid massage 2 times per day. All subjects will have a follow up of 24 weeks and we will compare results for both groups at the end of the study.
Dry eye syndrome with meibomian gland dysfunction alone or in combination of other type of dry eye.
Patients who were previously treated with eyelid massages and warm compresses without any improvement.
Pregnant women.
History of ocular surgery within three months prior to inclusion.
History of trauma, infection or inflammation within three months prior to inclusion.
Contact lens use in the last week before inclusion.
Parallel
Mibo Thermoflo
DeviceThermal therapy with Mibo Thermoflo for 11 minutes per eye, during each session.
Warm compresses and eyelid massage
Other interventionWarm compresses plus eyelid massage 2 times per day 11 minutes per eye.
Meibomian gland expressibility
Changes in meibomian gland structure will be evaluated by meibomian gland expressibility.
Meibum quality
Changes in meibomian gland structure will be evaluated with the meibum quality in slit lamp graded as: clear, opaque, granular and toothpaste for meibum worst secretion.
Corneal and conjunctival staining with fluorescein dye
Ocular surface damage will be graded with corneal and conjunctival staining with fluorescein dye.
Corneal and conjunctival staining with lissamine green dye
Ocular surface damage will be graded with corneal and conjunctival staining with lissamine green dye.
Short term changes with corneal and conjunctival staining with fluorescein dye
Short term changes in ocular surface damage will be graded with corneal and conjunctival staining with fluorescein dye.
Short term changes with corneal and conjunctival staining with lissamine green dye
Short term changes in ocular surface damage will be graded with corneal and conjunctival staining with lissamine green dye.
Short term changes in tear stability
Short term changes in tear stability will be measured with Tear Break-up Time (TBUT). A result \>10 seconds will be considered normal, a result \<10 seconds will be considered pathological.
Short term changes in Symptom Assessment in Dry Eye questionnaire (SANDE)
Short term changes in ocular surface symptoms will be assessed by the Symptom Assessment in Dry Eye (SANDE). The SANDE questionnaire has two questions presented in a visual scale. The two questions assess the frequency and severity of dry eye symptoms. A less rate prove changes in ocular surface symptoms and quality of life improvement.
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Universidad Autonoma de Nuevo Leon
Lead sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Collaborator
