Lipiflow vs iLux Patient Acceptance and Comfort Study

Introduction Meibomian gland disease (MGD) is increasingly recognized as a primary cause or contributor to tear instability and dry eye disease. Effective management of this disorder often requires meibomian gland expression and clearance. A variety of devices which apply pressure, heat or a combination of both to the glands have been used.

Two such devices that apply heat and pressure simultaneously are commercially available. LipiFlow (JNJ Vision Care) is an automated computer-controlled device that uses vectored thermal (hydraulic) pulsation applied by an activator device placed on the eye between the globe and the eyelids to achieve gland clearance. The iLux System (Alcon) is an operator controlled assisted manual device which applies heat generated by infrared LEDs and expression through cam driven mechanical pressure applied to the lids.

Device Descriptions LipiFlow Thermal Pulsation System

The Lipiflow Thermal Pulsation System is a commercially available device used in the treatment of MGD. It is cleared to be marketed by the United States Food and Drug Administration. The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.

The LipiFlow Console provides the user interface and control elements of the system, including all software, algorithms and control elements. The Activator, a single-use sterile device, delivers automated therapeutic energies to each meibomian gland. Its contoured design vaults the cornea and protects the eye allowing a maximum therapeutic temperature of 43 degrees Celsius to reach glands from the inner eyelid, without damaging the eyelid or delicate structures of the globe. Insulation protects the cornea from exceeding a safe 39.5 degrees Celsius, while a pressure feedback loop sends pulsed sequences to expel blockages. Force equalization protects the globe from pressure transmission by focusing energy only on the eyelid. Delivered through the LipiFlow Activator, Vectored Thermal Pulse™ (VTP) technology applies a combination of heat and pressure to the inner eyelid to safely remove gland obstructions and stagnant gland content. Vectored heat and adaptive force equalization target the pulse, heat, and pressure on the meibomian glands to maximize effectiveness. Therapeutic motion provides proximal-to-distal peristalsis to clear gland contents.