Ignite Creation Date:
2024-05-06 @ 2:53 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04454983
Status:
COMPLETED
Last Update Posted:
2020-08-19
First Post:
2020-06-28
Brief Title:
Lipiflow vs iLux Patient Acceptance and Comfort Study
Sponsor:
Epstein Arthur B OD FAAO
Organization:
Epstein Arthur B OD FAAO
Study Overview
Official Title:
Lipiflow vs iLux Patient Acceptance and Comfort Study
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was designed to compare patient acceptance comfort and preference between two meibomian gland clearing devices Lipiflow vs iLux Primary Objective was to compare patient comfort as assessed by Likert-style scale questionnaire following each bilateral procedure Secondary Objective was to compare overall experience and treatment preference as assessed by Likert-style questionnaire following each bilateral procedure Both devices are exempt from IDE regulations 21 CFR 8122c
Detailed Description:
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 395 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
iLux System
The iLux System is a medical device commercially available for use by Eye Care Professionals ECP to apply localized heat and pressure therapy to a patients eyelids It is cleared to be marketed by the United States Food and Drug Administration 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 an ECP to view the eyelid margin through a magnifier then warm the eyelid tissue to a range of 40 to 42C and then apply force-limited compression to the eyelid in order to express melted meibum from obstructed glands The iLux System is indicated 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
The iLux Instrument is a handheld electronic instrument used together with the iLux disposable to apply heating and pressure to the eyelid The Instrument includes electronic circuits that read sensors in the Inner and Outer Eyelid Pads to measure temperatures representative of inner and outer eyelid temperature respectively 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 A graphic Screen displays information for operating the Instrument during a treatment
Study Purpose Objectives This study is designed to compare patient acceptance comfort and preference between two meibomian gland clearing devices Both devices are exempt from IDE regulations 21 CFR 8122c Primary Objective is to compare patient comfort as assessed by Likert-style scale questionnaire following each bilateral procedure Secondary Objective is to compare overall experience and treatment preference as assessed by Likert-style questionnaire following each bilateral procedure
Background Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction listed on ClincalTrialsgov looked at a 4-week efficacy comparison between the two treatment devices Pain and discomfort data were collected regarding the two procedures but was not analyzed for significance due to no pre-trial hypothesis The raw data shows lower pain and discomfort scores immediately following the procedure for the Lipiflow as compared to iLux with similar pre-treatment and one-day post post-treatment scores Thornhill 2019 There is currently no published research on the patient acceptance comfort and preference comparing any meibomian gland emptying devices
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 395 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
iLux System
The iLux System is a medical device commercially available for use by Eye Care Professionals ECP to apply localized heat and pressure therapy to a patients eyelids It is cleared to be marketed by the United States Food and Drug Administration 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 an ECP to view the eyelid margin through a magnifier then warm the eyelid tissue to a range of 40 to 42C and then apply force-limited compression to the eyelid in order to express melted meibum from obstructed glands The iLux System is indicated 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
The iLux Instrument is a handheld electronic instrument used together with the iLux disposable to apply heating and pressure to the eyelid The Instrument includes electronic circuits that read sensors in the Inner and Outer Eyelid Pads to measure temperatures representative of inner and outer eyelid temperature respectively 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 A graphic Screen displays information for operating the Instrument during a treatment
Study Purpose Objectives This study is designed to compare patient acceptance comfort and preference between two meibomian gland clearing devices Both devices are exempt from IDE regulations 21 CFR 8122c Primary Objective is to compare patient comfort as assessed by Likert-style scale questionnaire following each bilateral procedure Secondary Objective is to compare overall experience and treatment preference as assessed by Likert-style questionnaire following each bilateral procedure
Background Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction listed on ClincalTrialsgov looked at a 4-week efficacy comparison between the two treatment devices Pain and discomfort data were collected regarding the two procedures but was not analyzed for significance due to no pre-trial hypothesis The raw data shows lower pain and discomfort scores immediately following the procedure for the Lipiflow as compared to iLux with similar pre-treatment and one-day post post-treatment scores Thornhill 2019 There is currently no published research on the patient acceptance comfort and preference comparing any meibomian gland emptying devices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None