Purpose: To compare the effectiveness and safety of the MicroShunt (Santen Inc) versus trabeculectomy in patients with primary open-angle glaucoma (POAG).
Design: Prospective, randomized, multicenter trial conducted in the United States and Europe.
Participants: Adult patients (aged 40-85 years) with mild to severe POAG inadequately controlled on maximum tolerated medical therapy and intraocular pressure (IOP) ≥ 15 mmHg and ≤ 40 mmHg.
Background: Although traditional surgical procedures for glaucoma (such as trabeculectomy and tube-shunt implantation) can significantly reduce intraocular pressure (IOP), they are associated with numerous complications, some of which are vision-threatening, or involve prolonged recovery or a highly intensive postoperative course. Micro-invasive glaucoma surgery (MIGS) procedures have shown better safety but reduced efficacy in achieving target IOP. Combinations of these methods have led to the development of subconjunctival micro-invasive procedures with safety comparable to traditional surgery and greater efficacy than minimally invasive methods.
View Article and Find Full Text PDFOphthalmol Glaucoma
April 2022
Purpose: To evaluate the claims-based 5-year economic and reintervention burden for patients with primary open-angle glaucoma (POAG) after incisional glaucoma surgery in the United States.
Design: Retrospective Medicare claims analysis.
Participants: One thousand nine hundred forty-five Medicare fee-for-service patients with POAG treated with trabeculectomy, tube shunt, or EX-PRESS shunt procedures from 2010 through 2011.
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.
Trabeculectomy remains the 'gold standard' intraocular pressure (IOP)-lowering procedure for moderate-to-severe glaucoma; however, this approach is associated with the need for substantial post-operative management. Micro-invasive glaucoma surgery (MIGS) procedures aim to reduce the need for intra- and post-operative management and provide a less invasive means of lowering IOP. Generally, MIGS procedures are associated with only modest reductions in IOP and are targeted at patients with mild-to-moderate glaucoma, highlighting an unmet need for a less invasive treatment of advanced and refractory glaucoma.
View Article and Find Full Text PDFAims: Paravalvular aortic regurgitation (PVAR) after balloon-expandable transcatheter aortic valve implantation (TAVI) remains difficult to quantify, and the utility of the AR index (ARi) to create a composite aortic insufficiency (CAI) score was an important advance. Heart rate (HR) influences the ARi but the clinical relevance of this phenomenon remains poorly appreciated. We sought to validate a new composite heart-rate-adjusted haemodynamic-echocardiographic aortic insufficiency (CHAI) score in the prognostic evaluation of PVAR after balloon-expandable TAVI.
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