E>EYE IRPL® TECHNOLOGY (Intense Regulated Pulsed Light) E-Swin USA

Description

A LONG-LASTING SOLUTION USING PATENTED IRPL^® TECHNOLOGY
(Intense Regulated Pulsed Light)

Designed and manufactured in France by E-SWIN, a leading manufacturer of high-tech medical equipment offering your patients a non-invasive, comfortable and completely harmless experience. The treatment is performed within a short, efficient protocol of 3-4 sessions.

E-Eye is a medical device, which is FDA cleared under 510(k) K200616 for the following indication for use: E-Eye is a prescription device indicated for the treatment of Rosacea.

Clinical literature may suggest that 80% of rosacea patients also suffer from Meibomian Gland Dysfunction.

Meibomian gland blockage and inflammation are important components of meibomian gland dysfunction in rosacea. Meibomian gland dysfunction changes the meibum quality and quantity, which can cause dry eye symptoms in affected individuals. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8267744/. J Clin Med. 2021 Jul; 10(13): 2897

Meibomian gland dysfunction has been identified as a principal cause of dry eye disease. It results in the tear film becoming unstable, leading to insufficient production, or excessive evaporation of tears. It is now acknowledged that most cases of evaporative dry eye are primarily due to a compromised external lipid layer of the lacrimal film, caused by malfunctioning meibomian glands.

How IRPL^® Technology Works

E>Eye treatment generates a new polychromatic pulsed light by producing perfectly calibrated and homogeneously sequenced light pulses. The sculpted pulses are delivered under the shape of regulated train pulses. The energy, spectrum and time period are precisely set to stimulate the meibomian glands to improve their function.

Easy to Use, Fast, and Tailor-Made for Optometrists & Ophthalmologists

• E>Eye is user-friendly and intuitive with no risk for errors.
• A treatment session can begin within a few seconds and takes only three minutes to perform.
• No preheating is required
• Small foot print. The E>Eye is a compact and mobile device that will fit into any eye care professional’s practice space.

Treatment Plan

Simple & Fast

Session treatments take only a few minutes.

• Patients are comfortably seated on a treatment chair, preferably tilted. The metal eyewear protection is adjusted on the patient’s eyes. Optical gel is then applied to the cheekbone and the temporal areas.
• A series of 5 flashes is applied under one eye, starting from the inner canthus up to the temporal area, using the nominal power.
• The same process is then repeated under the other eye.

Noticeable Improvements

IRPL® effect of the treatment appears very rapidly after each session and is cumulative. Usually the results last a minimum of 6 months. In order to improve the achieved results and to avoid returning discomfort, it is recommended to repeat single maintenance sessions on demand, with usually one single session per year.

The full success of treatment depends on compliance with a specific protocol. For optimal results, perform treatments on Day One, Day 15, and Day 45, and then as needed according to the patient’s symptoms.

Treatment Results

Quantified Efficiency

Clinical studies have been conducted in France, New Zealand, and China. These studies have shown the following:

1. A considerable improvement in the symptoms perceived by patients, with a 90% satisfaction rate after the first two treatments.

This improvement was confirmed by patients’ opinions regarding their level of discomfort before treatment versus their level of discomfort after treatment, as well as the improvement in fixation time while reading or watching television. An improvement was felt by patients quickly following the initial treatment, and for several days after treatment.  Perceived improvements became more prolonged after the second and third treatments.

1. A correlation between patients’ perceptions and clinical measurements executed.

45% of patients originally classified as level 2 (Oxford classification) have, after the instillation of fluorescein, improved by one or two levels. 81% of patients from level 1 have improved by one level.

These results were obtained two months (on average) after the third treatment.

Patients suffering from a more severe pathology, classified on the 3rd and 4th levels, will need to treat both inferior and superior eyelids. The ocular globe would need to be protected by a haptic contact lens. In these cases, improvement by one to two levels is expected.

View the advantages of exclusive IRPL®  technology versus conventional IPLs below.

IRPL^® vs IPL COMPARISON TABLE

A manufacturer and a product you can trust:

•  Received Medical CE Certification approval (European Standard) & TGA registration approval in 2013
• US FDA cleared under 510(k) K200616 for the following indication for use: E-Eye is a prescription device indicated for the treatment of Rosacea.
•  Comes with a 2-Year Warranty
•  New, Safe and Effective IRPL^® Technology (Intense Regulated Pulsed Light)
•  Made in France by E-Swin, the world’s largest medical IPL manufacturer.
•  Certified ISO 9001 and ISO 13485