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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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The use of poly(styrene-block-isobutyleneblock-styrene)as a microshunt to treat glaucoma

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Regenerative Biomaterials 2016年第2期3卷 137-142页

作者： Leonard Pinchuk Isabelle Riss Juan F.Batlle Yasushi P.Kato John B.Martin Esdras Arrieta paul palmberg Richard K.Parrish Bruce A.Weber Yongmoon Kwon Jean-Marie Parel InnFocus Inc.MiamiFLUSA Ophthalmic Biophysics Center Bascom Palmer Eye InstituteUniversity of Miami Miller School of MedicineMiamiFLUSA Pôle Ophtalmologique De La Clinique Mutualiste Pessac CedexFrance Centro Laser Santo DomingoDominican Republic Anne Bates Leach Eye Hospital University of MiamiBascom Palmer Eye InstituteMiller School of MedicineMiamiFLUSA Department of Ophthalmology University of Paris Hotel-Dieu HospitalParisFrance

The InnFocus MicroShuntVR is a minimally invasive glaucoma drainage microtube used to shunt aqueous humor from the anterior chamber of the eye to a flap formed under the conjunctiva and Tenon’s *** safety and clinical performance of this device approaches that of trabeculectomy with mitomycin C,the current‘gold standard’treatment for advanced *** invention of a new biomaterial called poly(styrene-block-isobutylene-block-styrene)or‘SIBS’is the enabling factor which led to the success of this *** is ultrastable with virtually no foreign body reaction in the body,which manifests as clinically insignificant inflammation and capsule formation in the *** lack of capsule formation enables unobstructed flow through the 70 mm lumen tube and the achievement of controlled low intraocular pressure,which is important for the management of *** article summarizes the integration of SIBS into a glaucoma drainage device and confirms its functionality with clinical success over a 2-year period.

关键词： biocompatibility medical device stent soft tissue

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Combined pars plana vitrectomy and Baerveldt glaucoma implant placement for refractory glaucoma

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International Journal of Ophthalmology(English edition) 2015年第5期8卷 916-921页

作者： Thalmon R.Campagnoli Sung Soo Kim William E.Smiddy Steve J.Gedde Donald L.Budenz Richard K.Parrish II paul F.palmberg William Feuer Wei Shi Department of Ophthalmology Bascom Palmer Eye InstituteUniversity of Miami Miller School of Medicine Department of Ophthalmology Gangnam Severance HospitalYonsei University College of Medicine Department of Ophthalmology University of North Carolina

AIMTo evaluate outcomes of combined pars plana vitrectomy and Baerveldt glaucoma implant (PPV-BGI) placement for refractory *** medical records of 92 eyes (89 patients) that underwent PPV-BGI were retrospectively reviewed, including 43 eyes with neovascular glaucoma (NVG) and 49 eyes with other types of glaucoma (non-NVG).RESULTSOutcome measures were visual acuity (VA), intraocular pressure (IOP), glaucoma medical therapy, complications, and success [VA>hand motions (HM), IOP≥6 mm Hg and ≤21 mm Hg, no subsequent glaucoma surgery]. Cumulative success rates for the non-NVG group and NVG group were 79% and 40% at 1y, respectively (P=0.038). No difference in the rates of surgical success were found between pars plana and anterior chamber tube placement. Preoperative IOP (mean±SD) was 30.3±11.7 mm Hg in the Non-NVG group and 40.0±10.6 mm Hg in the NVG group, and IOP was reduced to 15±9.5 mm Hg in the non-NVG group and 15±10.5 mm Hg in the NVG at 1y. Number of glaucoma medications (mean±SD) decreased from 2.7±1.3 in the non-NVG group and 2.8±1.3 in the NVG group preoperatively to 0.76±1.18 in the non-NVG group and 0.51±1.00 in the NVG group at 1y. Improvement in VA of ≥2 Snellen lines was observed in 25 (27%) eyes, although only 33% of non-NVG eyes and 2.3% of NVG eyes maintained VA better than 20/200 at 1y. Nonclearing vitreous hemorrhage was the most common postoperative complication occurring in 16 (17%) eyes, and postoperative suprachoroidal hemorrhages developed in 5 (5.4%) ***-BGI is a viable surgical option for eyes with refractory glaucoma, but visual outcomes are frequently poor because of ocular comorbidities, especially in eyes with NVG. The location of tube placement does not influence surgical outcome and should be left to the discretion of the surgeon.

关键词： glaucoma drainage device pars plana vitrectomy refractory glaucoma neovascular glaucoma

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