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

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Eye and Vision 2019年第1期6卷 303-311页

作者： Omar Sadruddin Leonard Pinchuk Raymund Angeles Paul Palmberg Santen Inc EmeryvilleCAUSA. InnFocus Inc. a Santen CompanyMiamiFLUSA Bascom Palmer Eye Institute University of Miami Miller School of MedicineMiamiFLUSA

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 *** glaucoma surgery(MIGS)procedures aim to reduce the need for intra-and post-operative management and provide a less invasive means of lowering ***,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 *** 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 *** lumen size is sufficiently small that at normal aqueous flow hypotony is avoided,but large enough to avoid being blocked by sloughed cells or *** 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 *** 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 *** implantation procedure can be performed in combination with cataract surgery or as a standalone *** 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 *** clinical studies assessing the long-term safety and efficacy of the MicroShunt have been completed;a Phase 3 multicenter,randomized clinical study comp

关键词： Ab externo Glaucoma Micro-invasive glaucoma surgery MicroShunt Mitomycin C sibs polymer

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Preliminary results of Preserflo Microshunt versus Preserflo Microshunt and Ologen implantation

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Eye and Vision 2021年第1期8卷 324-337页

作者： Iraklis Vastardis Sofia Fili Georgios Perdikakis Kalliopi Kontopoulou Miltos Balidis Zisis Gatzioufas Markus Kohlhaas Department of Ophthalmology St.Johannes Academic Hospital DortmundDortmundGermany Ophthalmica Eye Institute ThessalonikiGreece Department of Ophthalmology University Hospital BaselBaselSwitzerland

Purpose:To report preliminary 6-month results on the use of the Preserflo Microshunt implant with and without Ologen in 50 pseudophakic eyes with moderate to advanced primary open-angle glaucoma(POAG).Methods:Fifty pseudophakic eyes underwent ab externo Preserflo Microshunt *** was gathered retrospectively and two groups were then created,group A with application of MMC 0.2 mg/ml and group B with MMC 0.2 mg/ml and Ologen collagen matrix(OCM)*** success was regarded as the percentage of eyes achieving:a)5≤intraocular pressure(IOP)≤13 mmHg,b)5≤IOP≤16 mmHg,and c)5≤IOP≤21 mmHg without additional medication or surgery and qualified success was regarded as the percentage of eyes achieving a)IOP≤13 mmHg,b)IOP≤16 mmHg,and c)IOP≤21 mmHg with or without *** was performed using a log-rank Kaplan-Meier test.A scatterplot analysis presented the treatment effect data of all eyes with a minimum of 20%IOP reduction per *** was defined as requiring additional surgery,IOP greater than 21 mmHg with or without medication and failure to reach 20%IOP ***:Mean postoperative IOP was significantly lower in both *** decreased by 49.06%in group A and by 53.01%in group B at 6 months(P0.05).Cumulative IOP results per case were not statistically different in group A compared with group *** revision surgery in group A(4%failure rate)and three in group B(12%failure rate)were ***:Both groups showed equal results in terms of cumulative and mean IOP reduction,medication reduction as well as in absolute and qualified success *** significant difference was found in any parameters tested between Preserflo Microshunt with MMC 0.2 mg/ml and with or without OCM implantation at 6 ***-term follow-up is required to fu

关键词： Micro invasive glaucoma surgery Ab externo surgery Refractory POAG sibs polymer Mitomycin C

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