PreserFlo®MicroShunt:这种开角型青光眼微创设备的概述

G. Gambini, Matteo Mario Carlà, Federico Giannuzzi, T. Caporossi, Umberto De Vico, A. Savastano, A. Baldascino, Clara Rizzo, Raphael Kilian, A. Caporossi, S. Rizzo
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引用次数: 19

摘要

对于中重度青光眼,小梁切除术仍然是降低眼压的“金标准”;然而,这种方法需要广泛的术后维护。微创青光眼手术(MIGS)治疗旨在减轻术中和术后护理负担,同时为轻度至中度青光眼患者提供可接受的IOP降低。PreserFlo®MicroShunt(以前的InnFocus MicroShunt)是一种8.5毫米青光眼引流装置,由聚苯乙烯块-异丁烯块-苯乙烯块(SIBS)制成,这是一种极具生物相容性和生物惰性的材料。管腔足够窄,以防止低斜视,但足够大,以避免被脱落的细胞或色素阻塞。该装置可以作为一个单独的手术植入体外,也可以与白内障手术一起植入术中丝裂霉素C,并在结膜和Tenon囊下产生一个水泡。MicroShunt于2012年获得ce认证,设计用于原发性开角型青光眼,其IOP在最大耐受局部治疗后仍不受控制。已经进行了几项评估MicroShunt长期安全性和有效性的临床试验,强调了该设备随着时间的推移的有效性,以及可容忍的安全性。本综述旨在收集PreserFlo在引入近10年后的有效性和安全性结果的证据,并进一步将其与其他MIGS和治疗青光眼的金标准小梁切除术进行比较。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
PreserFlo® MicroShunt: An Overview of This Minimally Invasive Device for Open-Angle Glaucoma
For moderate-to-severe glaucoma, trabeculectomy remains the “gold standard” intraocular pressure (IOP)-lowering treatment; nonetheless, this method requires extensive post-operative maintenance. Microinvasive glaucoma surgery (MIGS) treatments are designed to lessen intra- and post-operative care burden while offering an acceptable IOP decrease for individuals with mild to moderate glaucoma. The PreserFlo® MicroShunt (previously InnFocus MicroShunt) is an 8.5 mm glaucoma drainage device manufactured from poly(styrene-block-isobutylene-block-styrene) (SIBS), an extremely biocompatible and bioinert material. The lumen is narrow enough to prevent hypotony, but big enough to avoid being obstructed by sloughed cells or pigment. The device is implanted ab externo, as a stand-alone procedure or in conjunction with cataract surgery, with intraoperative mitomycin C, and a bleb is produced under the conjunctiva and Tenon’s capsule. The MicroShunt was CE-marked in 2012 and designed for primary open-angle glaucoma, the IOP of which remains uncontrolled after maximally tolerated topical treatment. Several clinical trials evaluating the MicroShunt’s long-term safety and effectiveness have been conducted, highlighting the effectiveness of the device over time, along with a tolerable safety profile. The present review aims to gather evidence of PreserFlo’s effectiveness and safety results almost 10 years after its introduction, and furthermore, to compare it with other MIGS and with the gold-standard trabeculectomy for glaucoma management.
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