New Ultrasound-Based Device Provides Non-Invasive Treatment for Glaucoma Patients
A French start-up is developing the first ultrasonic apparatus fitted with a miniaturized single-use device to reduce glaucoma-related intraocular pressure. This is a promising therapeutic approach.Glaucoma affects 80 million people worldwide and is the second biggest cause of blindness. This degenerative disease of the optic nerve is usually accompanied by increased intraocular pressure and needs to be monitored throughout a patient’s lifetime. Currently available treatment includes eye drops, laser treatment and invasive surgery (trabulectomy and sclerectomy), which causes post-operative complications: inflammation, pressure-related problems and haemorrhaging. "We thought, why not treat eyes without opening them up? We use high-intensity focused ultrasound to gently coagulate the aqueous-humour producing part of the ciliary body," explains Fabrice Romano, who invented this technology and founded Eye Tech Care.Romano's company, based in Rilleux-la-Pape near Lyon, invested 20 million euros to develop this unique ultrasound cyclocoagulation technology in collaboration with INSERM's (French National Institute of Health and Medical Research). "No less than eight patents have been registered on EyeOP1's various components. They cover component shape and design, as well as the frequency, intensity and duration of ultrasound waves emitted," explains Dietrich Wolf, Eye Tech Care’s CEO. The portable system comprises an ultrasound generator with control module and a probe. The control module measures 36 cm (length) by 32 cm (width), 25 cm (height) and weighs 7 kg. It has a touchscreen to log and control the entire treatment procedure. The probe consists of six miniaturized (40 mm2) piezoelectric transducers arranged in a circle. This ensures the ultrasound waves emitted converge with great precision in the treatment area. A single-use cone is used to correctly position the therapy probe on patients' eyeballs. Each transducer delivers ultrasound blasts to the ciliary body at a frequency of 21 megahertz and an acoustic power of 2 watts for a total of three minutes.Eye Tech Care has just presented the second generation of its medical device, which has been CE marked since June 2011. "With its optimized positioning cone, improved transducer geometry and new treatment protocol, this new generation offers real advantages: significant results for patients and easier operation for practitioners via simple, reproducible procedures," continues Wolf. The results of recent multicentre clinical trials were presented at the last French Society of Ophthalmology congress in Paris. They show this device is now more efficient while retaining excellent tolerance. Initially reserved for refractory glaucoma resistant to conventional treatment, Eye Tech Care's technology was then used to treat patients suffering from progressive glaucoma with uncontrolled intraocular pressure. It has now reached a second clinical milestone by moving onto glaucoma patients with no history of surgery. "Our non-invasive treatment can now be offered to more patients. This new therapeutic procedure will soon be indispensable for treating glaucoma patients, who often dread surgery," says Wolf.Over 1,500 patients have already been treated in over twenty ophthalmology centres in France and across Europe. Eye Tech Care intends to continue expanding throughout Europe and roll out its medical technology in the USA but also in emerging markets, such as China, India and Latin America. Since these regions do not have enough infrastructures, they cannot treat glaucoma surgically. "Our non-invasive therapeutic approach is the ideal alternative," says a delighted Wolf, whose company is aiming to meet the needs of this rapidly expanding global market. According to Market Scope, 120 million people worldwide suffer from glaucoma and ocular hypertension, only 30% of whom have been diagnosed.
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