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

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 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 (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.

Ultrasound ciliary plasty in glaucoma treatment: A long‐term follow‐up study

“…The rate of occurrence of major complications in our study was similar to the results published to date (Aptel et al, 2016;Deb-Joardar & Reddy, 2018;Denis et al, 2015;Figus et al, 2021;Giannaccare et al, 2019Giannaccare et al, , 2021Rouland & Aptel, 2021).…”

“…The decrease in IOP and the number of antiglaucoma medications was statistically significant at each follow-up time point. The mean IOP at 24-month follow-up was reduced by 30.7%, similar to two-year follow-up studies (Figus et al, 2021;Giannaccare et al, 2021;Leshno et al, 2020). In our study, the mean IOP at the last follow-up was reduced by 28.5%, similar to another study with a longer than 24-month follow-up (Rouland & Aptel, 2021).…”

“…This complication resolved 1 month after discontinuation of antiglaucoma medications. Hypotony and transient choroidal detachment was also observed in other studies (Figus et al, 2021;Leshno et al, 2020;Morais Sarmento et al, 2019;Rouland & Aptel, 2021). Macular oedema occurred in 4.8% of patients 1 month after the procedure, and all patients with oedema had coexistence of the epiretinal membrane.…”

“…Consequently, it reduces damage to the adjacent tissues. Until now few studies present results of 24‐month follow‐up (Figus et al, 2021; Giannaccare et al, 2021; Leshno et al, 2020), and only one result of 36‐months follow‐up (Rouland & Aptel, 2021) with around 30% IOP reduction and without the occurrence of major complications. This quite new cyclodestruction method with a good safety profile allows for the treatment of moderate glaucoma in earlier stages.…”

Ultrasound cyclo-plasty for moderate glaucoma: Eighteen-month results from a prospective study

“…In the eye, ultrasound can heat tissue at any depth or location with precise temperature control. The volume of the treated tissue can be appropriately adjusted, and the integrity of the adjacent tissue can be preserved, therefore minimizing surgical complications (25). However, some patients still experienced complications, such as conjunctival hyperemia, corneal edema, aqueous flare, and hyphema, all of which gradually disappeared within a month and did not require interventional therapy.…”