Safety and Effectiveness of the PRESERFLO® MicroShunt in Primary Open-Angle Glaucoma: Results from a 2-Year Multicenter Study

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Beckers, Henny J.M. and Aptel, Florent and Webers, Carroll A.B. and Angeles, Raymund and Bluwol, Elisa and Martínez de la Casa, Jose Maria and García Feijoo, Julián and Lachkar, Yves and Méndez Hernández, Carmen Dora and Riss, Isabelle and Shao, Hui and Pinchuk, Leonard and Sadruddin, Omar and Shaarawy, Tarek M. (2021) Safety and Effectiveness of the PRESERFLO® MicroShunt in Primary Open-Angle Glaucoma: Results from a 2-Year Multicenter Study. Ophthalmology Glaucoma, 5 (2). pp. 195-209. ISSN 2589-4196

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Official URL: https://doi.org/10.1016/j.ogla.2021.07.008




Abstract

To assess the safety and effectiveness of the PRESERFLO® MicroShunt (formerly InnFocus MicroShunt) in patients with primary open-angle glaucoma (POAG).The MicroShunt, a controlled ab externo glaucoma filtration surgery device, was investigated in a 2-year, multicenter, single-arm study.Eligible patients were aged 18-85 years with POAG inadequately controlled on maximal tolerated medical therapy with intraocular pressure (IOP) ≥18 and ≤35 mmHg or when glaucoma progression warranted surgery.The MicroShunt was implanted as a stand-alone procedure with adjunctive use of topical mitomycin C (MMC; 0.2-0.4 mg/ml) for 2-3 minutes.The primary effectiveness outcome was IOP reduction and success (not requiring reoperation or pressure failures [IOP > 21 mmHg and < 20% reduction in IOP]) at year 1. Additional end points at year 2 included IOP reduction, success, glaucoma medications, adverse events (AEs), and reoperations. Results are reported in the overall population and subgroups of patients receiving 0.2 or 0.4 mg/ml MMC.In 81 patients, mean (± standard deviation [SD]) IOP decreased from 21.7 ± 3.4 mmHg at baseline to 14.5 ± 4.6 mmHg at year 1 and 14.1 ± 3.2 mmHg at year 2 (P < 0.0001). Overall success (with and without supplemental glaucoma medication use) at year 1 was 74.1%. Mean (± SD) number of medications decreased from 2.1 ± 1.3 at baseline to 0.5 ± 0.9 at year 2 (P < 0.0001), and 73.8% of patients were medication free. Most common nonserious AEs were increased IOP requiring medication or selective laser trabeculoplasty (25.9%) and mild-to-moderate keratitis (11.1%). There were 6 (7.4%) reoperations and 5 (6.2%) needlings by year 2. In an analysis (post hoc) according to MMC concentration, overall success was 78.1% (0.2 mg/ml) and 74.4% (0.4 mg/ml; P = 0.710). In the 0.2 and 0.4 mg/ml MMC groups, 51.9% and 90.3% of patients were medication free, respectively (P = 0.001). There was a trend toward lower IOP and higher medication reduction in the 0.4 mg/ml MMC subgroup.In this study, mean IOP and glaucoma medication reductions were significant and sustained over 2 years postsurgery. No long-term, sight-threatening AEs were reported. Further studies may confirm potential risk/benefits of higher MMC concentration


Item Type:Article
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Received 1 April 2021, Revised 16 July 2021, Accepted 21 July 2021, Available online 28 July 2021, Version of Record 22 March 2022.

Uncontrolled Keywords:Clinical trial, Glaucoma filtration surgery, MIGS, Primary open-angle glaucoma.
Subjects:Medical sciences > Medicine > Surgery
Medical sciences > Medicine > Ophtalmology
Medical sciences > Optics > Visual perception
ID Code:71396
Deposited On:27 Jul 2022 11:26
Last Modified:03 Aug 2022 10:48

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