Ultrasound Cyclo Plasty for Treatment of Surgery-Naïve Open-Angle Glaucoma Patients: A Prospective, Multicenter, 2-Year Follow-Up Trial

Background: The purpose of this prospective study was to evaluate the efficacy and safety of the Ultrasound Cyclo Plasty (UCP) procedure using high-intensity focused ultrasound in surgery-naïve open-angle glaucoma patients. Methods: prospective, non-randomized, single-arm, multicenter clinical trial...

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Autores principales:	Michele Figus, Chiara Posarelli, Marco Nardi, Ingeborg Stalmans, Evelien Vandewalle, Shlomo Melamed, Alon Skaat, Ari Leshno, David Cordeiro Sousa, Luis Abegão Pinto
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	glaucoma ultrasound ciliary body intraocular pressure prospective study Medicine R
Acceso en línea:	https://doaj.org/article/449b41f626604179bc49283ef2c13e46
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spelling	oai:doaj.org-article:449b41f626604179bc49283ef2c13e462021-11-11T17:36:41ZUltrasound Cyclo Plasty for Treatment of Surgery-Naïve Open-Angle Glaucoma Patients: A Prospective, Multicenter, 2-Year Follow-Up Trial10.3390/jcm102149822077-0383https://doaj.org/article/449b41f626604179bc49283ef2c13e462021-10-01T00:00:00Zhttps://www.mdpi.com/2077-0383/10/21/4982https://doaj.org/toc/2077-0383Background: The purpose of this prospective study was to evaluate the efficacy and safety of the Ultrasound Cyclo Plasty (UCP) procedure using high-intensity focused ultrasound in surgery-naïve open-angle glaucoma patients. Methods: prospective, non-randomized, single-arm, multicenter clinical trial. Sixty-six eyes with primary open-angle glaucoma, intraocular pressure (IOP) ≥21 mmHg and with no history of filtering surgery were enrolled. Patients were treated by UCP with a therapy probe comprising six piezoelectric transducers, consecutively activated for 8 s each. Complete ophthalmic examination was performed before the procedure, 1 day after the procedure, and 1, 3, 6, 12, 18 and 24 months after the procedure. Primary outcomes were complete success (defined as IOP lowering from baseline ≥20% without additional glaucoma medications) and vision-threatening complications. Secondary outcomes were the presence of complications and the reduction of the number of medications used. Results: IOP was significantly reduced after one procedure (<i>p</i> < 0.05), from a mean pre-operative value of 24.3 ± 2.9 mmHg (n = 2.3 hypotensive medications) to a mean value of 15.9 ± 3.6 mmHg (n = 2.2 hypotensive medications) at 2 years (mean IOP lowering of 33%). Surgical success was achieved in 74% of eyes. Notwithstanding side effects such as transient anterior chamber inflammation, refractive error changes, transient hypotony and macular edema, no major intra or post-operative complications such as phthisis, induced cataract, neovascularization or significant vision loss were observed. Conclusions: Ultrasound Cyclo Plasty is a valuable, effective and well-tolerated procedure to lower IOP in patients with open-angle glaucoma without previous filtering surgery.Michele FigusChiara PosarelliMarco NardiIngeborg StalmansEvelien VandewalleShlomo MelamedAlon SkaatAri LeshnoDavid Cordeiro SousaLuis Abegão PintoMDPI AGarticleglaucomaultrasoundciliary bodyintraocular pressureprospective studyMedicineRENJournal of Clinical Medicine, Vol 10, Iss 4982, p 4982 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	glaucoma ultrasound ciliary body intraocular pressure prospective study Medicine R
spellingShingle	glaucoma ultrasound ciliary body intraocular pressure prospective study Medicine R Michele Figus Chiara Posarelli Marco Nardi Ingeborg Stalmans Evelien Vandewalle Shlomo Melamed Alon Skaat Ari Leshno David Cordeiro Sousa Luis Abegão Pinto Ultrasound Cyclo Plasty for Treatment of Surgery-Naïve Open-Angle Glaucoma Patients: A Prospective, Multicenter, 2-Year Follow-Up Trial
description	Background: The purpose of this prospective study was to evaluate the efficacy and safety of the Ultrasound Cyclo Plasty (UCP) procedure using high-intensity focused ultrasound in surgery-naïve open-angle glaucoma patients. Methods: prospective, non-randomized, single-arm, multicenter clinical trial. Sixty-six eyes with primary open-angle glaucoma, intraocular pressure (IOP) ≥21 mmHg and with no history of filtering surgery were enrolled. Patients were treated by UCP with a therapy probe comprising six piezoelectric transducers, consecutively activated for 8 s each. Complete ophthalmic examination was performed before the procedure, 1 day after the procedure, and 1, 3, 6, 12, 18 and 24 months after the procedure. Primary outcomes were complete success (defined as IOP lowering from baseline ≥20% without additional glaucoma medications) and vision-threatening complications. Secondary outcomes were the presence of complications and the reduction of the number of medications used. Results: IOP was significantly reduced after one procedure (<i>p</i> < 0.05), from a mean pre-operative value of 24.3 ± 2.9 mmHg (n = 2.3 hypotensive medications) to a mean value of 15.9 ± 3.6 mmHg (n = 2.2 hypotensive medications) at 2 years (mean IOP lowering of 33%). Surgical success was achieved in 74% of eyes. Notwithstanding side effects such as transient anterior chamber inflammation, refractive error changes, transient hypotony and macular edema, no major intra or post-operative complications such as phthisis, induced cataract, neovascularization or significant vision loss were observed. Conclusions: Ultrasound Cyclo Plasty is a valuable, effective and well-tolerated procedure to lower IOP in patients with open-angle glaucoma without previous filtering surgery.
format	article
author	Michele Figus Chiara Posarelli Marco Nardi Ingeborg Stalmans Evelien Vandewalle Shlomo Melamed Alon Skaat Ari Leshno David Cordeiro Sousa Luis Abegão Pinto
author_facet	Michele Figus Chiara Posarelli Marco Nardi Ingeborg Stalmans Evelien Vandewalle Shlomo Melamed Alon Skaat Ari Leshno David Cordeiro Sousa Luis Abegão Pinto
author_sort	Michele Figus
title	Ultrasound Cyclo Plasty for Treatment of Surgery-Naïve Open-Angle Glaucoma Patients: A Prospective, Multicenter, 2-Year Follow-Up Trial
title_short	Ultrasound Cyclo Plasty for Treatment of Surgery-Naïve Open-Angle Glaucoma Patients: A Prospective, Multicenter, 2-Year Follow-Up Trial
title_full	Ultrasound Cyclo Plasty for Treatment of Surgery-Naïve Open-Angle Glaucoma Patients: A Prospective, Multicenter, 2-Year Follow-Up Trial
title_fullStr	Ultrasound Cyclo Plasty for Treatment of Surgery-Naïve Open-Angle Glaucoma Patients: A Prospective, Multicenter, 2-Year Follow-Up Trial
title_full_unstemmed	Ultrasound Cyclo Plasty for Treatment of Surgery-Naïve Open-Angle Glaucoma Patients: A Prospective, Multicenter, 2-Year Follow-Up Trial
title_sort	ultrasound cyclo plasty for treatment of surgery-naïve open-angle glaucoma patients: a prospective, multicenter, 2-year follow-up trial
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/449b41f626604179bc49283ef2c13e46
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Ultrasound Cyclo Plasty for Treatment of Surgery-Naïve Open-Angle Glaucoma Patients: A Prospective, Multicenter, 2-Year Follow-Up Trial

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