People suffering with glaucoma may benefit from a new, non-invasive procedure that directs high-intensity-focused ultrasound into the eye.
French company EyeTechCare is performing clinical trials at Edouard Herriot Hospital in Lyon on a new medical technology called EyeOP1 that directs finely focused ultrasound beams into the ciliary bodies of a patient’s eye through miniaturised transducers in a ring-shape probe. The beams pass through eye tissue without disruption and reach the target area through the focal point, which has a volume of less than 0.3mm3.
According to the company, the procedure can be administered on an outpatient basis under local anaesthesia and it takes around one minute. A typical procedure will require the patient to lie down close to the EyeOP1 command module and the disposable therapy device will be placed on the globe of the eyeball.
The command module enables the ophthalmologist to set parameters for the procedure and to control it throughout the treatment period. A generator delivers power to the piezoelectric transducers, while the pressure reduction system applies suction and ensures the fixation of the therapy device to the eyeball, guaranteeing that it remains centred throughout the entire procedure.
Fabrice Romano, the chairman of EyeTechCare, said that the main objective of all glaucoma treatments is to decrease the intra-ocular pressure, which is the is the fluid pressure of the aqueous humor inside the eye. With traditional surgery, this involves using either a laser treatment or making cuts in the eye to reduce the pressure. A surgeon will need to strike the circumference of the eye between 20 and 40 times to be effective.
EyeTechCare claims that these multiple applications are an occasional source of error and always lack reproducibility.
Romano said the difference with his company’s method is that the circular EyeOP1 device is capable of treating the entire circumference of the eye. The device incorporates six transducers, which are among the smallest ever manufactured for therapeutic applications, and each one is activated around the circumference sequentially.
According to Romano, each transducer has a surface area of 35mm2 and is only 200 microns thick. Yet they are able to work with a frequency as high as 20MHz, which is significant when compared with other HIFU machines that run at levels around 4MHz, he said.
Romano, a veterinary ophthalmologist who developed the concept for the EyeOP1 four years ago, explained that a US company tried to develop a similar ultrasound-based technology to treat glaucoma about 25 years ago without success.
‘Like in many cases, it was too early,’ he said. ‘They weren’t able to work at high frequency at that moment. Twenty five years after, the technology is now very advanced.’
Romano set up EyeTechCare in Lyon with business partners Philippe Chapuis and Laurent Farcy two years ago.
With the success of clinical trials currently being undertaken on a dozen patients in Lyon, Romano said that his company will achieve the C-Mark approval for use in clinical settings by the end of this year.
EyeTechCare is then hoping to do even more extensive trials of the device in 15 centres across Europe with a minimum of 100 patients. ‘These treatments are really new for ophthalmologists and we need to convince them with clinical data,’ he said.
Yet there are those who have warned about the effectiveness of the technique for all cases of glaucoma.
David Wright, chief executive of the International Glaucoma Association, said that the patients being trialled with the EyeOP1 have a form of the disease known as ‘refractory glaucoma’, which is one of the less common forms and it is difficult to treat with conventional oculo-hypotensive techniques.
‘It should be stressed that the new technique is only being trialled on this specific and small group of glaucoma patients and, if the new technique proves to be effective, then it would represent an improvement over the existing methods of managing refractory glaucoma,’ he said. ‘The lack of tissue damage and the absence of inflammation, which cause a spike in the intra-ocular pressure following the existing laser techniques, would certainly be welcome, providing that the effect of the treatment is maintained in the long term.’