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
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 ps...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 implantation.Data 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)implantation.Absolute 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 medication.Evaluation 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 case.Failure was defined as requiring additional surgery,IOP greater than 21 mmHg with or without medication and failure to reach 20%IOP reduction.Results:Mean postoperative IOP was significantly lower in both groups.IOP decreased by 49.06%in group A and by 53.01%in group B at 6 months(P<0.88),respectively.Medication use was lower in both groups(Wilcoxon test,P<0.001).The absolute and qualified success rates were not statistically significant between the groups(all P>0.05).Cumulative IOP results per case were not statistically different in group A compared with group B.One revision surgery in group A(4%failure rate)and three in group B(12%failure rate)were performed.Conclusions:Both groups showed equal results in terms of cumulative and mean IOP reduction,medication reduction as well as in absolute and qualified success rates.No 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 months.Long-term follow-up is required to further evaluate this data.展开更多
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 implantation.Data 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)implantation.Absolute 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 medication.Evaluation 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 case.Failure was defined as requiring additional surgery,IOP greater than 21 mmHg with or without medication and failure to reach 20%IOP reduction.Results:Mean postoperative IOP was significantly lower in both groups.IOP decreased by 49.06%in group A and by 53.01%in group B at 6 months(P<0.88),respectively.Medication use was lower in both groups(Wilcoxon test,P<0.001).The absolute and qualified success rates were not statistically significant between the groups(all P>0.05).Cumulative IOP results per case were not statistically different in group A compared with group B.One revision surgery in group A(4%failure rate)and three in group B(12%failure rate)were performed.Conclusions:Both groups showed equal results in terms of cumulative and mean IOP reduction,medication reduction as well as in absolute and qualified success rates.No 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 months.Long-term follow-up is required to further evaluate this data.
