Take Control of Dry Eye Treatment with iLux®
Handheld and portable, iLux is easily incorporated into your practice and patient workflow. Packed with technology and features designed to make MGD treatment fast and effective, iLux puts the future of dry eye treatment in the palm of your hand.
iLux® treats Meibomian Gland Dysfunction by the application of light-based heat and compression under direct visualization.
The iLux MGD treatment system:
- Consists of the handheld iLux device and the sterile, single-patient-use disposable Smart Tip.
- Uses light energy to soften blockages of the meibomian gland orifices quickly and comfortably.
- Lets you manually adjust eyelid compression based on your clinical judgment.
- Lets you view meibomian gland orifices, so you can tailor your treatment to each patient’s needs.
- Is great value for patients and practice, bringing relief to more eyes while boosting your bottom line.
The iLux device allows an eye care professional (ECP) to view the eyelid margin through the magnifier, then warm the eyelid tissue within a therapeutic target range to melt the meibum blocking the orifices, and then apply compression to the eyelid to express the melted meibum through the orifices. iLux can treat both upper and lower eyelids.
At all times, the amount of heat and pressure applied is under direct control of the ECP who monitors the response of the eyelid margin and the comfort of the patient.
iLux by TearFilm Innovations allows direct visualization of meibomian glands, blockages, and expressed meibum throughout treatment via the magnifying lens, providing a direct view of the treatment area.
The proprietary light-based heat source gently warms the inner and outer lid to a safe therapeutic temperature. Sensors in the disposable iLux Smart Tip monitor inner eyelid temperature continuously during treatment.
One-button control of heating and compression puts treatment in the doctors\' hands, allowing you to choose the location and duration of treatment. iLux measures compression force, which is displayed on the LCD screen.
The iLux® Smart Tip: Small package, big technology
The sterile, single-patient-use, disposable iLux Smart Tip has an inner pad and an outer pad. The inner pad slips behind the eyelid being treated, while the outer pad is pressed against the outer surface of the eyelid during heating and compression. Both pads are covered with a soft, biocompatible silicone material.
The iLux Smart Tip contains precision temperature sensors which continually monitor inner and outer eyelid temperature and maintain safe, therapeutic heat levels during treatment.
Information from the Smart Tip is relayed to the iLux device, controlling the LED light sources to increase or decrease treatment temperature as needed.
iLux Clinical Study Summary
Tear Film Innovations, Inc. conducted a randomized, open-label, multisite clinical trial
comparing the iLux System to a predicate device as part of the FDA premarket notification
clearance process. The goal of the study was to verify that technological differences between
the iLux System and the control do not adversely affect safety and effectiveness. A total of
142 subjects were enrolled at 8 study sites and were randomized for bilateral treatment in a
1:1 ratio between the iLux treatment group and the comparator group.
The objective of this study was to compare changes in meibomian gland function and
evaporative dry eye (EDE) symptoms after treatment with the iLux and a predicate device.
Primary effectiveness endpoints of Meibomian Gland Score (MGS) and Tear Break-up Time
(TBUT) as well as the secondary endpoint of Ocular Surface Disease Index (OSDI) symptom
scores were measured along with safety outcomes.
Overall, both treatments (iLux and predicate) produced statistically and clinically
significant improvements in the signs and symptoms of MGD. The iLux met the criteria
for non-inferiority relative to the predicate for both primary effectiveness endpoints –
MGS and TBUT. OSDI also improved significantly from baseline in both treatment groups.
Pivotal Clinical Study: 142 patients, 8 sites
Statistically Significant Improvement in signs and symptoms of Dry Eye and MGD
Results
Meibomian Gland Score
MGS improved significantly from baseline in both treatment groups at both week 2 and
week 4. The 4-week change of 18 points in the iLux group was also substantially
greater than the 5-point threshold for clinical significance.
Tear Break-up Time
TBUT improved significantly from baseline in both treatment groups at both week 2
and week 4. The 4-week change of 2.79 seconds in the iLux group was also greater
than the clinically significant level of 2.5 seconds.
Ocular Surface Disease Index
OSDI improved significantly from baseline in both treatment groups at both week 2
and week 4. The 4-week change of 31 points in the iLux group was substantially greater
than the 7-point threshold for clinical significance.
Indications for Use:
The iLux System is indicated for the application of localized heat and pressure therapy in
adult patients with chronic diseases of the eyelids, including meibomian gland dysfunction
(MGD), also known as evaporative dry eye.
The iLux MGD treatment system:
• Consists of the handheld iLux device, and the sterile, single-patient use
disposable Smart Tip
• Uses light energy to warm meibomian glands quickly and comfortably
• Allows targeted therapy based on location of diseased glands
• Lets you manually adjust gland compression based on your clinical
judgement
• Provides a view of meibomian gland orifices, so you can tailor your treatment
to each patient’s needs
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