A Blink-Assisted, Cornea-Sparing Wearable Eyelid Device for the EffectivePenetration of Therapeutic Thermal Energy into the Meibomian Glandsfor the Treatment of Dry Eye Disease

Abstract

Meibomian Gland Dysfunction (MGD) is the leading cause of Dry Eye Disease (DED). In MGD, obstructed meibomian glands result in reduced meibum secretion and a compromised tear lipid layer that causes tear film instability and an accelerated evaporation of tears. This accelerated and excessive tear evaporation in turn leads to the signs and symptoms of DED. Research has demonstrated that an elevated and sustained therapeutic temperature of at least 41°C at the tarsal conjunctiva located at inner surface of the eyelid can liquefy hardened or thickened meibum and help clear gland obstructions in MGD. By clearing the obstructions, restored meibomian glands can resume the production of meibum that can flow naturally out of the glands and onto the tear surface thereby restoring a stable and healthy tear film lipid layer. Fortifying the lipid layer by enhancing natural meibum production is an effective treatment for evaporative dry eye disease. In recent years, several devices have been developed that utilize thermal energy to treat DED and MGD that require heating from inside the eyelids. The medical community has debated the ability to achieve therapeutic level of temperatures at the tarsal conjunctiva via a non-invasive external approach. This article discusses a new device, TearCare, that has achieved and maintained the requisite 41°C therapeutically-effective, meibum-melting temperature at the tarsal conjunctiva non-invasively through a combination of novel features including: wearability, total tarsal conformance, blink assistance, and software sensor-controlled thermal maximization and optimization.