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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - Me-Check (Me-Check - Screening of the dry eye syndrome)

Teaser

Summary

Dry eye (DE) syndrome, or keratoconjunctivis sicca, is an autoimmune disorder of the ocular surface that affects more than 35% of the population, and most frequently the female gender. The dry eye is present all over the world: there are about 350 million people suffering from it in the Western market (Europe, Australia, the Americas) and as many in Asia and Africa, for a total of over 700 million patients in increase of over 6-7% per year. It consists of qualitative and quantitative alteration of the tear film, whose main function is lubrification, nutrition, optical transparency, cleanliness, and as the main defence to bacterial infections, both corneal and conjunctival. The most common symptoms of the disease are burning, foreign body sensation, photophobia, itching, stinging, irritation, redness, blepharospasm, difficulty in opening eyelids on awakening, and, in severe cases, pain and blurred vision. If left untreated, this condition can lead to pain, ulcers, scars on the cornea, and some loss of vision. Dry eye can make it more difficult to perform some activities, such as using a computer or reading for an extended period, and it can decrease tolerance for dry environments, such as the air inside an airplane. The prevalence of patient-diagnosed dry eye syndrome ranges from 14% to 33%. Similarly, the prevalence of clinician-diagnosed dry eye ranges from 1% to 22%. Published epidemiological data on dry eye syndrome in France, Germany, Italy, Spain, Sweden, and the UK shows that approximately 70% of sufferers were female in all six countries, except Germany (58% of sufferers). In Germany, Italy, Sweden, and the UK, the ophthalmologists estimated that over half their patients were between 46 and 65 years of age, whereas in France and Spain over 40% of patients were >65 years of age.
Me-Check overcomes the limitations shown by traditional methods and delivers tangible and direct benefits to its end-users: It allows to do a complete automatic and objective screening: in 3 minutes it is possible to define if the patient has the dry eye. It allows to reach a specific result, indeed the device gives two fundamental indications: 1. Meibomian gloss disfunction level and 2. The eye dry gravity level. The device does not require specific skills of dry eye pathology indeed the property software indicates the pathology level. This method can be used by the ophthalmologists for their routine examination. It is a very easy to use method: it can be used on customer slot lamp, with freehand or with dedicated station.

Work performed

The technological and practical feasibility has been demonstrated through different way of investigation. They have been carried out clinical trials and studies in real case scenarios. University Professors, Opticians, Optometrists and Ophthalmologists coming from UK, USA, Germany Belgium, Netherland, Spain tested first prototypes with patients and targeted customers. The experts also presented the ongoing works and first tested prototype in the most important European and American exhibition and the ophthalmic congress (25-27th January 2019, Opti, Munich, Germany; 23-25th February 2019, Mido, Milan, Italy; 14-16 March 2019, AICCER, Milan, Italy; 3-7th May 2019, ASCRS, San Diego, USA; 25-28th May, PAAO, Cancun, Mexico). Public free demonstration in hospitals and clinics carried out in collaborative formats and all the trials resulted in refine targets, features and stakeholders. In addition, such demonstrations and tests allowed to identify new distribution channels: Pharmacies and widespread points of contact with clients. Ten fully functional prototypes were produced and validated by Key Opinion Leaders Prof. Lucio Buratto (Founder of â€œCentro Italiano Occhio Seccoâ€, Milan, Italy), Dr. Karl Stonecipher (North Carolina University, USA) and optometrists, Dr. Heiko Pult (College of Optometry, Munich, Germany), Prof. Pietro Gheller (University of Padua, Italy) Prof James Wolffsohn (Aston University, UK).
The product obtained the CLASS I CE Medical Device registration in the Italian Ministry of Health compliant with 93/42/CEE Rule and with standard EN 60601-1. It allows to sell the equipment throughout Europe and in all non-EU countries that accept this certification. In next months, certification procedures for the most important non-European countries will begin.
The product found a strong interest in many countries: USA, Latin America, Middle East, China, therefore it will be evaluated the certification in such countries in order to start a consequent distribution. Price has been verified and reviewed through customer groups with a specific analysis of production costs and interview with main stakeholders and market studies.

Final results

The final product shows a great step over previous solutions on the diagnosis of the Dry- eye syndrome. Me-Check indeed overcomes the limitations shown by traditional methods and delivers tangible and direct benefits to its end-users, allowing to do a complete automatic and objective screening in 2/3 minutes. It has demonstrated to be very easy to use, with an immediate understanding; it is extremely versatile and it can be used on customers slot lamp, with free hand or with dedicated stations; it can be easily updated with a software upgrade.
Me-Check addresses the needs of a large B2B user base including 370.000 in EU-28 among subjects responsible for eye disease visits and treatment. End users are patients that goes to a routine visit. A very rapid diagnosis, the widespread possibility to identify the disease and the consequent early diagnosis prevent the sanitary system to be overcharged with patient in a late stage of the pathology and to save public resources.