Ultrasound cyclo plasty for treatment of surgery-naïve open-angle glaucoma patients: A prospective, multicenter, 2-year follow-up trial

Michele Figus, Chiara Posarelli, Marco Nardi, Ingeborg Stalmans, Evelien Vandewalle, Shlomo Melamed, Alon Skaat, Ari Leshno, David Cordeiro Sousa, Luis Abegão Pinto

Research output: Contribution to journalArticlepeer-review

Abstract

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 sur-gery-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 pro-cedure, 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 (p < 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.

Original languageEnglish
Article number4982
JournalJournal of Clinical Medicine
Volume10
Issue number21
DOIs
StatePublished - 1 Nov 2021

Keywords

  • Ciliary body
  • Glaucoma
  • Intraocular pressure
  • Prospective study
  • Ultrasound

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