Lipiflow vs iLux Patient Acceptance and Comfort Study

August 16, 2020 updated by: Dr. Arthur Epstein, Epstein, Arthur B., OD, FAAO
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 812.2(c)].

Study Overview

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 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.

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 patient's 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 42˚C, 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 812.2(c)]. 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 ClincalTrials.gov 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 Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Phoenix Eye Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject can be of any gender or race
  2. Subject must be 18 years of age or older at the time of informed consent

2. Subject must be able to understand and must sign an Informed Consent that has been approved by an IRB 3. Subject must have confirmed diagnosis of Meibomian Gland Dysfunction 4. Subject must agree to not wear contact lenses the day of the Study visit

Exclusion Criteria:

  1. History of intraocular or oculoplastic surgery within 6 months of Screening visit
  2. History of ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the Screening visit
  3. Active ocular infection or active ocular inflammation (including allergic conjunctivitis, vernal or giant papillary conjunctivitis) at time of Screening visit
  4. History of ocular surface abnormality that may compromise corneal integrity
  5. History of treatment with LipiFlow or iLux in either eye in the last 6 months
  6. Allergy to topical proparacaine eye drops

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lipiflow - All Subjects
Both Lipiflow and iLux procedures were performed bilaterally on all subjects on the same day. Subjects were randomized to which procedure they received first. There was a 1-hour wait between procedures.
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.
Experimental: iLux - All Subjects
Both Lipiflow and iLux procedures were performed bilaterally on all subjects on the same day. Subjects were randomized to which procedure they received first. There was a 1-hour wait between procedures.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure Comfort
Time Frame: 5 minutes
Likert-scale questionnaire: 1=strongly disagree, 2=disagree, 3=Undecided, 4=Agree, 5=strongly agree - 1 Question
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure Experience
Time Frame: 5 minutes
Likert-scale questionnaire: 1=strongly disagree, 2=disagree, 3=Undecided, 4=Agree, 5=strongly agree - 4 Questions
5 minutes
Patient Preference
Time Frame: 5 minutes
Questionnaire: Lipiflow, iLux, No Preference
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Arthur B Epstein, OD, Ophthalmic Research Consultants of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2020

Primary Completion (Actual)

February 29, 2020

Study Completion (Actual)

February 29, 2020

Study Registration Dates

First Submitted

June 28, 2020

First Submitted That Met QC Criteria

June 30, 2020

First Posted (Actual)

July 2, 2020

Study Record Updates

Last Update Posted (Actual)

August 19, 2020

Last Update Submitted That Met QC Criteria

August 16, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Eye

Clinical Trials on Lipiflow Thermal Pulsation System

3
Subscribe