Lipiflow vs iLux Patient Acceptance and Comfort Study

NACompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

January 11, 2020

Primary Completion Date

February 29, 2020

Study Completion Date

February 29, 2020

Conditions
Meibomian Gland DysfunctionDry Eye
Interventions
DEVICE

Lipiflow Thermal Pulsation System

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. 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™ technology applies a combination of heat and pressure to the inner eyelid to safely remove gland obstructions and stagnant gland content. Therapeutic motion provides proximal-to-distal peristalsis to clear gland contents.

DEVICE

iLux System

The iLux™ System is used to apply localized heat and pressure to a patient's eyelids. The system consists of a handheld instrument coupled to a single-use, sterile disposable component that is positioned to bridge the eyelid. The iLux device allows view of the eyelid through a magnifier, then warms the eyelid to 40 to 42˚C, then force-limited compression is applied manually to express the melted meibum from obstructed glands. Warming is accomplished using light energy emitted from LEDs in the Instrument. The LEDs are located behind a clear window on the open end of the Shroud. Two wavelengths of light are used: lime-green (568 nm) and near-infrared (850 nm). A mechanism in the Instrument allows the operator to apply pressure to the eyelid by controlling the movement of the Outer Pad using finger pressure applied to the Compression Control button. The force applied to the Compression Control is measured by a sensor in this mechanism.

Trial Locations (1)

85032

Phoenix Eye Care, Phoenix

All Listed Sponsors
collaborator

Johnson & Johnson Vision Care, Inc.

INDUSTRY

lead

Epstein, Arthur B., OD, FAAO

INDIV

NCT04454983 - Lipiflow vs iLux Patient Acceptance and Comfort Study | Biotech Hunter | Biotech Hunter