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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Meibomian gland expressibility
Timeframe: Basal to 24 weeks
Meibum quality
Timeframe: Basal to 24 weeks
Corneal and conjunctival staining with fluorescein dye
Timeframe: Basal to 24 weeks
Corneal and conjunctival staining with lissamine green dye
Timeframe: Basal to 24 weeks
Tear Break-up Time (TBUT)
Timeframe: Basal to 24 weeks
Schirmer test with and without anesthesia
Timeframe: Basal to 24 weeks
Symptom Assessment in Dry Eye questionnaire (SANDE)
Timeframe: Basal to 24 weeks
Ocular Surface Disease Index (OSDI)
Timeframe: Basal to 24 weeks
Karim Mohamed-Noriega, M.D.
Dry Eye Questionnaire 5 (DEQ-5)
Timeframe: Basal to 24 weeks
Tear osmolarity
Timeframe: Basal to 24 weeks
Change in tear of matrix metalloproteinase 9 (MMP-9)
Timeframe: Basal to 24 weeks
Non-Invasive Keratograph Break-up Time (NIKBUT)
Timeframe: Basal to 24 weeks
Tear meniscus height
Timeframe: Basal to 24 weeks
Conjuctival hyperemia
Timeframe: Basal to 24 weeks
Lipid layer thickness
Timeframe: Basal to 24 weeks
Adverse events
Timeframe: Basal to 24 weeks