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Jean-Francois Rouland, Florent Aptel; Results at 18 months of a prospective pilot series of Primary Open Angle Glaucoma patients treated by High Intensity Focused Ultrasound (HIFU) with the new generation probe.. Invest. Ophthalmol. Vis. Sci. 2016;57(12):6479.
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© ARVO (1962-2015); The Authors (2016-present)
To assess the safety and efficacy of Ultrasound Ciliary Plasty (UCP procedure) using HIFU (high intensity focused ultrasound) with a second-generation probe which increases the treatment surface area and the firing duration in patients with primary open angle glaucoma.
Prospective clinical series performed in two University Hospitals, on twenty eyes of twenty patients with primary open-angle glaucoma, treated with the EyeOP1 medical device since October 2013. New generation of device is equipped with six miniaturized cylindrical piezoelectric transducers with an increased lesion volume. All eyes were treated with an 8-second exposure time per transducer. The main assessment criteria were safety and efficacy measured by the incidence of complications and IOP reduction. Ophthalmic examination and ultrasound biomicroscopy were performed before treatment and during clinical follow-up at D7, M1, M3, M6, M12 and M18.
No major intra- or post-operative complications were observed during follow-up period. Clinical examination showed no lesions of ocular structures other than the ciliary body and no or few signs of intraocular inflammation after treatment. The mean intraocular pressure was significantly reduced (p<0.05) from 28.6 ± 5.3 mmHg [21-38] before treatment to 18.9 ± 6.7 mmHg [10-35] at last follow-up. Three patients have needed a second ultrasound procedure. Success rate, as defined by an IOP reduction >20% after one or two UCP procedures was 79%. The mean IOP reduction achieved in responding patients was 35%.
Coagulation of the ciliary body using high intensity focused ultrasound carried out with the new-generation of miniaturized transducers is a simple, well-tolerated procedure which enables to significantly reduce the intraocular pressure in patients with Open Angle Glaucoma. Increasing the lesion volume seems to increase the rate of responder patients.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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