Henny J M Beckers1, Florent Aptel2, Carroll A B Webers3, Elisa Bluwol4, José M Martínez-de-la-Casa5, Julián García-Feijoó5, Yves Lachkar4, Carmen D Méndez-Hernández5, Isabelle Riss6, Hui Shao7, Leonard Pinchuk8, Raymund Angeles7, Omar Sadruddin7, Tarek M Shaarawy9. 1. University Eye Clinic, Maastricht University Medical Center, Maastricht, the Netherlands. Electronic address: henny.beckers@mumc.nl. 2. CHU de Grenoble-Alpes, Grenoble, France. 3. University Eye Clinic, Maastricht University Medical Center, Maastricht, the Netherlands. 4. Hôpital Paris Saint Joseph, Paris, France. 5. Departamento de Oftalmologia Universidad Complutense, Hospital Clínico San Carlos, OFTARED, Madrid, Spain. 6. Pôle Ophtalmologique de la Clinique Mutualiste, Bordeaux, France. 7. Santen Inc., Emeryville, California. 8. InnFocus Inc., a Santen Company, Miami, Florida. 9. Hôpitaux Universitaires de Genève, Geneva, Switzerland.
Abstract
PURPOSE: To assess the safety and effectiveness of the PRESERFLO® MicroShunt (formerly InnFocus MicroShunt) in patients with primary open-angle glaucoma (POAG). DESIGN: The MicroShunt, a controlled ab externo glaucoma filtration surgery device, was investigated in a 2-year, multicenter, single-arm study. PARTICIPANTS: 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. METHODS: 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. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSIONS: 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.
PURPOSE: To assess the safety and effectiveness of the PRESERFLO® MicroShunt (formerly InnFocus MicroShunt) in patients with primary open-angle glaucoma (POAG). DESIGN: The MicroShunt, a controlled ab externo glaucoma filtration surgery device, was investigated in a 2-year, multicenter, single-arm study. PARTICIPANTS: 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. METHODS: 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. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSIONS: 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.
Authors: Marta Ibarz Barberá; Fátima Martínez-Galdón; Elena Caballero-Magro; Marta Rodríguez-Piñero; Pedro Tañá-Rivero Journal: J Glaucoma Date: 2022-05-17 Impact factor: 2.290
Authors: Ralph J S van Mechelen; Jarno E J Wolters; Marjolein Herfs; Christian J F Bertens; Marion Gijbels; Leonard Pinchuk; Theo G M F Gorgels; Henny J M Beckers Journal: Transl Vis Sci Technol Date: 2022-08-01 Impact factor: 3.048
Authors: Anthony P Khawaja; Ingeborg Stalmans; Florent Aptel; Keith Barton; Henny Beckers; Thomas Klink; Giorgio Marchini; Jose Martínez de la Casa; Jan H Simonsen; Marc Töteberg-Harms; Clemens Vass; Luís Abegão Pinto Journal: Ophthalmol Ther Date: 2022-07-07
Authors: Alessandro Rabiolo; Karl Mercieca; Raj Bhayani; Jose Maria Martínez de la Casa; Michele Figus; Karsten Klabe Journal: Eye (Lond) Date: 2022-03-12 Impact factor: 3.775