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,so...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.This review describes the use of one of these devices,the poly(styrene-block-isobutylene-block-styrene)(SIBS)-based PreserFlo MicroShunt(Santen,Emeryville,CA),in the surgical treatment of patients with glaucoma.Main text The MicroShunt is an 8.5-mm tube made of an inert polymer with no endplate,an internal diameter of 70μm,and fins intended to prevent peritubular flow and anchor the device within the sclera to prevent proximal migration into the eye.Following ab externo implantation,the tube provides a conduit for flow of aqueous humor from the anterior chamber into the subconjunctival/sub-Tenon space.Clinical trials to date have shown that,when paired with mitomycin C(MMC)treatment,MicroShunt implantation significantly reduced both IOP and the number of glaucoma medications.These IOP-lowering results were found both when surgery was performed alone and with phacoemulsification.The MicroShunt also showed a safety profile comparable to that of traditional filtering surgery.Conclusions The MicroShunt and other novel subconjunctival procedures have shown substantial IOP reductions while mitigating hypotony-related complications.MMC,which modulates fibrosis and scarring postoperatively,is essential to surgical success.Randomized,long-term clinical trials will further clarify the role of controlled micro-incisional device-assisted ab externo glaucoma filtering surgery in long-term glaucoma management.展开更多
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...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 trabeculectomy is underway.In preliminary studies,the MicroShunt effectively reduced IOP and use of glaucoma medications up to 3 years after implantation,with an acceptable safety profile.This article summarizes current literature on the unique properties of the MicroShunt,the preliminary efficacy and safety findings,and discusses its potential use as an alternative to trabeculectomy for glaucoma surgery.展开更多
A novel polyolefin called poly(styrene-block-isobutylene-block-styrene)(“SIBS”)originated from Joseph P.Kennedy’s laboratory at the University of Akron(Akron,Ohio,United States)and was developed as a biomaterial fo...A novel polyolefin called poly(styrene-block-isobutylene-block-styrene)(“SIBS”)originated from Joseph P.Kennedy’s laboratory at the University of Akron(Akron,Ohio,United States)and was developed as a biomaterial for long-term implant applications by the author.SIBS has no cleavable groups on its backbone or sidechains,is comprised predominantly of alternating secondary and quaternary carbons on its backbone,which prevents embrittlement and cracking under flexion,and undergoes multiple purification steps which renders it extremely biocompatible and well-suited for long-term applications in the eye.This article explores two ophthalmic devices;1)the PRESERFLO®MicroShunt(Santen Pharmaceutical Co.Ltd.,Osaka,Japan)made from SIBS that lowers intraocular pressure to thwart progression of vision loss from glaucoma,and 2)a novel intraocular lens(IOL)made from crosslinked polyisobutylene,which is under-development by Xi’an Eyedeal Medical Technology Co.,Ltd.(Xi’an,China)that does not glisten nor cloud over time,as do most conventional IOLs.展开更多
文摘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.This review describes the use of one of these devices,the poly(styrene-block-isobutylene-block-styrene)(SIBS)-based PreserFlo MicroShunt(Santen,Emeryville,CA),in the surgical treatment of patients with glaucoma.Main text The MicroShunt is an 8.5-mm tube made of an inert polymer with no endplate,an internal diameter of 70μm,and fins intended to prevent peritubular flow and anchor the device within the sclera to prevent proximal migration into the eye.Following ab externo implantation,the tube provides a conduit for flow of aqueous humor from the anterior chamber into the subconjunctival/sub-Tenon space.Clinical trials to date have shown that,when paired with mitomycin C(MMC)treatment,MicroShunt implantation significantly reduced both IOP and the number of glaucoma medications.These IOP-lowering results were found both when surgery was performed alone and with phacoemulsification.The MicroShunt also showed a safety profile comparable to that of traditional filtering surgery.Conclusions The MicroShunt and other novel subconjunctival procedures have shown substantial IOP reductions while mitigating hypotony-related complications.MMC,which modulates fibrosis and scarring postoperatively,is essential to surgical success.Randomized,long-term clinical trials will further clarify the role of controlled micro-incisional device-assisted ab externo glaucoma filtering surgery in long-term glaucoma management.
基金support was provided by Lucy Cartwright,MChem,Helios Medical Communications,Cheshire,UKfunded by Santen.MicroShunt studies were sponsored by InnFocus,a Santen company.
文摘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 trabeculectomy is underway.In preliminary studies,the MicroShunt effectively reduced IOP and use of glaucoma medications up to 3 years after implantation,with an acceptable safety profile.This article summarizes current literature on the unique properties of the MicroShunt,the preliminary efficacy and safety findings,and discusses its potential use as an alternative to trabeculectomy for glaucoma surgery.
文摘A novel polyolefin called poly(styrene-block-isobutylene-block-styrene)(“SIBS”)originated from Joseph P.Kennedy’s laboratory at the University of Akron(Akron,Ohio,United States)and was developed as a biomaterial for long-term implant applications by the author.SIBS has no cleavable groups on its backbone or sidechains,is comprised predominantly of alternating secondary and quaternary carbons on its backbone,which prevents embrittlement and cracking under flexion,and undergoes multiple purification steps which renders it extremely biocompatible and well-suited for long-term applications in the eye.This article explores two ophthalmic devices;1)the PRESERFLO®MicroShunt(Santen Pharmaceutical Co.Ltd.,Osaka,Japan)made from SIBS that lowers intraocular pressure to thwart progression of vision loss from glaucoma,and 2)a novel intraocular lens(IOL)made from crosslinked polyisobutylene,which is under-development by Xi’an Eyedeal Medical Technology Co.,Ltd.(Xi’an,China)that does not glisten nor cloud over time,as do most conventional IOLs.
