Ab externo implantation of the MicroShunt, a poly (styrene-block-isobutylene-blockstyrene) surgical device for the treatment of primary open-angle glaucoma: a review  

作　　者：Omar Sadruddin Leonard Pinchuk Raymund Angeles Paul Palmberg 

机构地区：[1]Santen Inc,Emeryville,CA,USA. [2]InnFocus Inc.,a Santen Company,Miami,FL,USA [3]Bascom Palmer Eye Institute,University of Miami Miller School of Medicine,Miami,FL,USA

出　　处：《Eye and Vision》2019年第1期303-311,共9页眼视光学杂志（英文）

基　　金：support was provided by Lucy Cartwright,MChem,Helios Medical Communications,Cheshire,UK;funded by Santen.MicroShunt studies were sponsored by InnFocus,a Santen company.

摘　　要：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.Microinvasive 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.The PRESERFLO®MicroShunt(formerly known as InnFocus MicroShunt)is an 8.5 mm-long(outer diameter 350μm;internal lumen diameter 70μm)glaucoma drainage device made from a highly biocompatible,bioinert material called poly(styrene-block-isobutylene-blockstyrene),or SIBS.The lumen size is sufficiently small that at normal aqueous flow hypotony is avoided,but large enough to avoid being blocked by sloughed cells or pigment.The MicroShunt achieves the desired pressure range in the eye by draining aqueous humor from the anterior chamber to a bleb formed under the conjunctiva and Tenon’s capsule.The device is implanted ab externo with intraoperative Mitomycin C via a minimally invasive(relative to incisional surgery)surgical procedure,enabling precise control of placement without the need for gonioscopy,suture tension control,or suture lysis.The implantation procedure can be performed in combination with cataract surgery or as a standalone procedure.The MicroShunt received ConformitéEuropéenne(CE)marking in 2012 and is intended for the reduction of IOP in eyes of patients with primary open-angle glaucoma in which IOP remains uncontrolled while on maximum tolerated medical therapy and/or in which glaucoma progression warrants surgery.Three clinical studies assessing the long-term safety and efficacy of the MicroShunt have been completed;a Phase 3 multicenter,randomized clinical study comparing the MicroShunt to primary trabe

关 键 词：Ab externo GLAUCOMA Micro-invasive glaucoma surgery MicroShunt Mitomycin C SIBS polymer 

分 类 号：R73[医药卫生—肿瘤]