Certified medical device

E-Eye has been subjected to clinical studies in order to obtain medical certification – a guarantee of performance and safety.

The objective of this clinical analysis was to demonstrate the effects of intense pulsed light in the treatment of meibomian gland dysfunction and to evaluate the safety and effectiveness of a pulsed light treatment device on meibomian gland dysfunction linked to meibomian blepharitis.

This study was based on various data: analysis of medical records, E-Eye tests, a clinical study of the E-Eye in Australia and New Zealand, and another clinical study in China.

Summary of E-Eye testing

The tests were performed by Dr. Christian Malbrel, an ophthalmologist in Reims, France.

Type of treatment: Treatment with a polychromatic pulsed light device of the dysfunction called dry eye in its corneal form caused by a deficiency of the lipid layer.

Panel: 80 volunteer participants. The test was carried out over a 6-month period. The objective was to verify the performance and safety when set to maximum power, which is the current setting of E-Eye.

Summary of key findings

Performance and safety was demonstrated in 80 participants. The E-Eye medical device used was completely identical to the model that’s manufactured and marketed in terms of settings and physical characteristics.

The main results demonstrated in this study are:

The results are those identified by the patients themselves (comfort, improved focus time, e.g. when reading or on the computer) and those measured by the ophthalmologist (by instilling fluorescein and, for some patients, use of a glare test).

In no cases did the patient’s condition worsen. The E-Eye system proved easy to use and did not endanger their vision.

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