Remind me, what is TearCare?
The TearCare System uses localized heat, applied using SmartLids technology, to the patient’s upper and lower eyelids.
The heat softens the thick meibum that is present in patients with meibomian gland dysfunction, and after the 15-minute heat treatment, the doctor manually expresses the softened meibum from the meibomian glands.
How much heat does it deliver?
The TearCare System’s intelligent design delivers a consistent level of therapeutic heat (45˚ C) to the outer surface of the eyelids to achieve and maintain an inner eyelid temperature of 41˚ C to 42˚ C—the inner eyelid temperature necessary to melt meibum.
Tell me about the studies.
The FDA clearance is based on data from multiple studies of the TearCare System, including recent safety and efficacy clinical data from the pivotal OLYMPIA study published in Cornea.
At 1 month post treatment, patients who received a single TearCare procedure showed significant improvements in mean tear film breakup time and meibomian gland secretion score.
TearCare patients also showed significant reductions in mean eye dryness, Symptom Assessment in Dry Eye (SANDE), and Ocular Surface Disease Index (OSDI) scores.
In the study, 72% of TearCare patients showed OSDI improvement by at least one severity category, and 81% of TearCare patients met Miller’s definition of clinically meaningful improvement in OSDI. (via)