AIM: This study aimed to expound the individual idea of micro-invasive surgery from pre-operative preparation, intra-operative processing and post-operative management. METHODS: Pre-operative preparation was improve...AIM: This study aimed to expound the individual idea of micro-invasive surgery from pre-operative preparation, intra-operative processing and post-operative management. METHODS: Pre-operative preparation was improved by analyzing pathological factors and hematoma property, and considering patients' age, basic disease, blood pressure control, with persistent haemorrhagia/rehaemorrhagia or not, operative occasion choice, positioning and other procedures. In the surgery, positioner was used. Initial aspiration volume was cautiously controlled. After operation, vital signs of patients were kept stable by cautiously using hematoma liquefacient and combining with free radical scavenger. RESULTS: The core content of individual micro-invasive surgery was mainly to relieve intracranial pressure. Under the condition of sufficient pre-operative preparation known by patients' family members, precise positioning was determined and individual therapeutic regimen was made. Meanwhile, caution should be taken in hematoma aspiration. Liquefaction and drainage should be paid more attention, and complications were processed actively. CONCLUSION: During the process of micro-invasive evacuation of intracranial hematoma for treating cerebral hemorrhage, attention should be paid to analyzing cerebral hematoma etiology and pathophysiological mechanism, and individual idea should be considered in surgical treatment aiming at patients' concrete disease condition.展开更多
AIM:To evaluate the effectiveness and safety of intravitreal ranibizumab(IVR)for diabetic macular edema(DME)in vitrectomized versus non-vitrectomized eyes.METHODS:The PubMed,EMBASE,Web of Science,Cochrane,EBSCO were c...AIM:To evaluate the effectiveness and safety of intravitreal ranibizumab(IVR)for diabetic macular edema(DME)in vitrectomized versus non-vitrectomized eyes.METHODS:The PubMed,EMBASE,Web of Science,Cochrane,EBSCO were comprehensively searched for studies comparing vitrectomized and non-vitrectomized eyes with DME.Clinical outcomes of best-corrected visual acuity(BCVA),central macular thickness(CMT),the mean number of intravitreal injection and adverse events were extracted and analyzed.RESULTS:Six studies involving 641 eyes were included.Final visual gain significantly improved and CMT significantly reduced in vitrectomized eyes at 6mo and 12mo visits(P<0.05).Although the mean reduction in CMT among non-vitrectomized eyes was significantly greater than in vitrectomized eyes at the 6mo[mean difference(MD)=53.57,95%confidence interval(CI):28.03 to 78.72,P<0.0001]and 12mo(MD=49.65,95%CI:19.58 to 79.72,P=0.01),no significant difference was detected in improvement in BCVA at either 6mo(MD=0.05,95%CI:-0.02 to 0.13,P=0.14)or 12mo(MD=0.03,95%CI:-0.04 to 0.09,P=0.43).Injection number of ranibizumab in non-vitrectomized eyes was significantly less than that in vitrectomized eyes during 6-month period(MD=0.60,95%CI:0.16 to 1.04,P=0.008),while there was no statistically significant difference between the two groups during 12mo of follow-up.CONCLUSION:Evidence from current study suggests that IVR was useful for both vitrectomized group and nonvitrectomized group with DME.Although less reduction in macular thickness is found in vitrectomized group,visual improvement between two groups is similar.展开更多
Objective The cardiac synchronization therapy (CRT) was proven to have good treatment for the cardiacconduction disorders patients with serious heart failure. But many disadvantages were gradually be noticed,such as d...Objective The cardiac synchronization therapy (CRT) was proven to have good treatment for the cardiacconduction disorders patients with serious heart failure. But many disadvantages were gradually be noticed,such as difficulty of sinus electrode implantation,coronary sinus injury and bleeding,still one third展开更多
AIM:To introduce a simple iris hook assisted phacoemulsification(PE)procedure and evaluate the safety and efficacy of it in completely vitrectomized eyes.METHODS:A single centre study which included 65 previously comp...AIM:To introduce a simple iris hook assisted phacoemulsification(PE)procedure and evaluate the safety and efficacy of it in completely vitrectomized eyes.METHODS:A single centre study which included 65 previously completely vitrectomized eyes of 62 patients who underwent cataract surgery.Patients were randomly divided into 3 groups.Patients received PE,and intraocular lens(IOL)implantation with the assistance of iris hook(SynergetiesTM)as group A(25 eyes);patients who received PE assisted with a 25 G pars plana irrigation as group B(20 eyes),and patients who received PE performed without the help of any instrument as group C(20 eyes).Main outcome measures were surgery duration,Ultrasound(U/S)total time,endothelial cell density(ECD),cumulative dissipated energy(CDE)and complications of the procedures.RESULTS:With the help of iris hook,the patients in group A had the lowest ECD loss rate(0.07±0.03,0.09±0.03,and 0.10±0.03,P<0.05),shortest CDE(12.2±4.1,15.8±6.0,and 16.0±6.0,P<0.05)and U/S total time(36.6±13.0 s,46.3±16.4 s,and 47.6±16.1 s,P<0.05),and minimal incidence of complications.The longest surgery duration was in group B(19.4±1.6 min)and maximum complications rate in group C(20%miosis,10%posterior capsular tears,5%zonular dialysis,5%cystoid macular edema).While best-corrected visual acuity(BCVA),intraocular pressure(IOP)and ECD did not show a significant difference among the three groups.CONCLUSION:Without prolonged surgery duration,the iris hook assistant method can minimize heat generation during surgery and incidence of complications,which transfer the challenged PE in vitrectomized eyes into a regular surgery.It does not need any change in the hydrodynamic parameters and in the bag PE technique,easy to operate even for junior surgeons.展开更多
Dear Sir,It is known that cataract surgery is challenging in vitrectomized eyes.Cataract surgeons may have encountered with posterior capsular complications and nucleus drop events even with minimal ocular manipulatio...Dear Sir,It is known that cataract surgery is challenging in vitrectomized eyes.Cataract surgeons may have encountered with posterior capsular complications and nucleus drop events even with minimal ocular manipulations and low irrigation bottle height.Inadvertent damage to the zonular fibers,posterior or peripheral lens capsule with ocutome or microvitreoretinal(MVR)blade in previous展开更多
Lee SM, Jung JW, Park SW, Lee JE, Byon IS. Retinal injury following intravitreal injection of a dexamethasone implant in a vitrectomized eye. Int J Ophthalmo12017; 10(6): 1019-1020
Purpose:.To evaluate the efficacy and safety of using coreoplasty,.and an iris-supported Artisan intraocular lens (IOL), for mydriasis and aphakic correction in post-traumatic vitrectomized eyes. Methods:.A total of 1...Purpose:.To evaluate the efficacy and safety of using coreoplasty,.and an iris-supported Artisan intraocular lens (IOL), for mydriasis and aphakic correction in post-traumatic vitrectomized eyes. Methods:.A total of 17 aphakic patients were admitted between April 2009 and April 2010 to the ophthalmologic department of Xiamen Eye Centre..All eyes had previously received lens removal and vitrectomy. After the retina stabilized and corrected visual acuity improved,.the iris was sutured. The Artisan IOL was fixated onto the iris surface..Patients were followed-up at one day, one week,.one month and three months postoperatively..The following outcomes were assessed: symptoms of photophobia and glare, uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), intraocular pressure (IOP), endothelial cell density (ECD). The diameter of pupil and the anterior chamber depth (ACD) were measured by the anterior segment optical coherence tomography (OCT). Results:.Artisan IOLs were successfully implanted in all aphakic eyes. Postoperatively, improvement was observed in photophobia and glare symptoms..UCVA was enhanced in all patients.(six eyes had better UCVA postoperatively than BCVA preoperatively)..However,.there were no significant changes in IOP. Mean loss of ECD was 336.06/mm2. Mean postoperative pupil diameter was 3.67±0.41 mm, compared with 5.67±0.57 mm preoperatively(P<0.05). Mean ACD was reduced by 0.88 mm.(3.38±0.33 mm preoperatively vs 2.50±0.35 mm postoperatively, P<0.05). Conclusion:.Surgery that combined coreoplasty and Artisan IOL implantation was a safe and effective treatment for correcting aphakia and mydriasis in post-traumatic vitrectomized eyes.展开更多
The glaucoma surgical landscape has changed dramatically over the last decade with the introduction and integration of micro-invasive glaucoma surgery(MIGS)techniques.These modalities target physiologic outflow pathwa...The glaucoma surgical landscape has changed dramatically over the last decade with the introduction and integration of micro-invasive glaucoma surgery(MIGS)techniques.These modalities target physiologic outflow pathways or optimize previously utilized glaucoma surgical methods in order to deliver safety,efficacy,and individualized care to the patient.MIGS techniques can be classified based on anatomical location as well as method of intraocular pressure(IOP)reduction.This review will focus on MIGS optimizing the conventional outflow pathway via intervention at Schlemm’s canal,MIGS optimizing the uveoscleral outflow pathway via suprachoroidal shunting,and MIGS optimizing the transscleral or subconjunctival outflow pathway which has long been utilized by glaucoma surgeons performing traditional filtration procedures.The wide array of currently available MIGS modalities can be staggering to the glaucoma care provider,but an understanding of the landscape and the large classes of interventional strategies can allow for clinical decision making based on the specifics of the patient’s needs and the pathophysiology of their disease.展开更多
Objective:To evaluate the clinical therapeutic effects of oral administration and external application of Chinese drugs combined with micro-invasive surgery for the treatment of varicose ulcers in the lower extremitie...Objective:To evaluate the clinical therapeutic effects of oral administration and external application of Chinese drugs combined with micro-invasive surgery for the treatment of varicose ulcers in the lower extremities(ecthyma).Methods:A total of 152 patients(163 limbs) suffering from varicose ulcers on the lower limbs were assigned to two groups according to the patients willingness.The 102 cases(109 limbs) in the treatment group underwent the method of endovenous microwave closure of communicating veins ...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
Background:Retrospective,consecutive case series to evaluate the implantation of two second-generation trabecular microbypass stents in combination with cataract surgery in a real-world,clinical setting.Methods:The se...Background:Retrospective,consecutive case series to evaluate the implantation of two second-generation trabecular microbypass stents in combination with cataract surgery in a real-world,clinical setting.Methods:The series included 56 eyes implanted with the iStent inject device with phacoemulsification.The series consisted of eyes with primary open-angle glaucoma(n=52)and pseudoexfoliative glaucoma(n=4).Primary outcome measures included intraocular pressure(IOP)and number of glaucoma medications.Safety outcomes included the need for secondary surgical intervention and the incidence of IOP spikes≥10 mmHg and≥15 mmHg.Results:IOP was reduced by 21%to 14.7±2.9 mmHg(p<0.01)at 6 months postoperative from 18.7±5.8 mmHg at baseline.Preoperatively,the mean number of glaucoma medications was 1.5±0.9 and reduced by 39%to 0.9±1.2(p<0.01)at 6 months.At 6 months,68%of eyes had an IOP≤15 mmHg,increased from 30%at baseline.55%of eyes were medication-free at 6 months,up from 18%at baseline.There were no severe postoperative complications.No eyes underwent an additional glaucoma procedure.Conclusions:Implantation of the iStent inject device with concomitant cataract surgery effectively provides a sustained reduction in IOP with a markedly improved medication burden out to 6 months postoperative.The safety profile is excellent.展开更多
Background:Retrospective,consecutive case series to evaluate the implantation of two sec on d-generation trabecular microbypass stents in combination with cataract surgery in a real-world,clinical setting.Methods:The ...Background:Retrospective,consecutive case series to evaluate the implantation of two sec on d-generation trabecular microbypass stents in combination with cataract surgery in a real-world,clinical setting.Methods:The series in eluded 56 eyes implanted with the iSte nt inject device with phacoemulsification.The series consisted of eyes with primary open-angle glaucoma(n=52)and pseudoexfoliative glaucoma(n=4).Primary outcome measures included intraocular pressure(IOP)and number of glaucoma medications.Safety outcomes included the need for secondary surgical intervention and the incidence of IOP spikes>10 mmHg and>15 mmHg.Results:IOP was reduced by 21%to 14.7±2.9 mmHg(P<0.01)at 6 months postoperative from 18.7±5.8 mmHg at baseline.Preoperatively,the mean number of glaucoma medications was 1.5±0.9 and reduced by 39% to 0.9±1.2(P<0.01)at 6 months.At 6 months,68%of eyes had an IOP<15 mmHg,increased from 30%at baseline.55%of eyes were medicati on-free at 6 months,up from 18%at baseline.There were no severe postoperative complications.No eyes underwent an additional glaucoma procedure.Conclusions:Implantation of the iStent inject device with concomitant cataract surgery effectively provides a sustained reduction in IOP with a markedly improved medication burden out to 6 months postoperative.The safety profile is excellent.展开更多
基金the National Natural Science Foundation of China, No. 3057062830770751
文摘AIM: This study aimed to expound the individual idea of micro-invasive surgery from pre-operative preparation, intra-operative processing and post-operative management. METHODS: Pre-operative preparation was improved by analyzing pathological factors and hematoma property, and considering patients' age, basic disease, blood pressure control, with persistent haemorrhagia/rehaemorrhagia or not, operative occasion choice, positioning and other procedures. In the surgery, positioner was used. Initial aspiration volume was cautiously controlled. After operation, vital signs of patients were kept stable by cautiously using hematoma liquefacient and combining with free radical scavenger. RESULTS: The core content of individual micro-invasive surgery was mainly to relieve intracranial pressure. Under the condition of sufficient pre-operative preparation known by patients' family members, precise positioning was determined and individual therapeutic regimen was made. Meanwhile, caution should be taken in hematoma aspiration. Liquefaction and drainage should be paid more attention, and complications were processed actively. CONCLUSION: During the process of micro-invasive evacuation of intracranial hematoma for treating cerebral hemorrhage, attention should be paid to analyzing cerebral hematoma etiology and pathophysiological mechanism, and individual idea should be considered in surgical treatment aiming at patients' concrete disease condition.
文摘AIM:To evaluate the effectiveness and safety of intravitreal ranibizumab(IVR)for diabetic macular edema(DME)in vitrectomized versus non-vitrectomized eyes.METHODS:The PubMed,EMBASE,Web of Science,Cochrane,EBSCO were comprehensively searched for studies comparing vitrectomized and non-vitrectomized eyes with DME.Clinical outcomes of best-corrected visual acuity(BCVA),central macular thickness(CMT),the mean number of intravitreal injection and adverse events were extracted and analyzed.RESULTS:Six studies involving 641 eyes were included.Final visual gain significantly improved and CMT significantly reduced in vitrectomized eyes at 6mo and 12mo visits(P<0.05).Although the mean reduction in CMT among non-vitrectomized eyes was significantly greater than in vitrectomized eyes at the 6mo[mean difference(MD)=53.57,95%confidence interval(CI):28.03 to 78.72,P<0.0001]and 12mo(MD=49.65,95%CI:19.58 to 79.72,P=0.01),no significant difference was detected in improvement in BCVA at either 6mo(MD=0.05,95%CI:-0.02 to 0.13,P=0.14)or 12mo(MD=0.03,95%CI:-0.04 to 0.09,P=0.43).Injection number of ranibizumab in non-vitrectomized eyes was significantly less than that in vitrectomized eyes during 6-month period(MD=0.60,95%CI:0.16 to 1.04,P=0.008),while there was no statistically significant difference between the two groups during 12mo of follow-up.CONCLUSION:Evidence from current study suggests that IVR was useful for both vitrectomized group and nonvitrectomized group with DME.Although less reduction in macular thickness is found in vitrectomized group,visual improvement between two groups is similar.
文摘Objective The cardiac synchronization therapy (CRT) was proven to have good treatment for the cardiacconduction disorders patients with serious heart failure. But many disadvantages were gradually be noticed,such as difficulty of sinus electrode implantation,coronary sinus injury and bleeding,still one third
基金Supported by the Research and Development Program of Shaanxi Province(No.2021SF-161)。
文摘AIM:To introduce a simple iris hook assisted phacoemulsification(PE)procedure and evaluate the safety and efficacy of it in completely vitrectomized eyes.METHODS:A single centre study which included 65 previously completely vitrectomized eyes of 62 patients who underwent cataract surgery.Patients were randomly divided into 3 groups.Patients received PE,and intraocular lens(IOL)implantation with the assistance of iris hook(SynergetiesTM)as group A(25 eyes);patients who received PE assisted with a 25 G pars plana irrigation as group B(20 eyes),and patients who received PE performed without the help of any instrument as group C(20 eyes).Main outcome measures were surgery duration,Ultrasound(U/S)total time,endothelial cell density(ECD),cumulative dissipated energy(CDE)and complications of the procedures.RESULTS:With the help of iris hook,the patients in group A had the lowest ECD loss rate(0.07±0.03,0.09±0.03,and 0.10±0.03,P<0.05),shortest CDE(12.2±4.1,15.8±6.0,and 16.0±6.0,P<0.05)and U/S total time(36.6±13.0 s,46.3±16.4 s,and 47.6±16.1 s,P<0.05),and minimal incidence of complications.The longest surgery duration was in group B(19.4±1.6 min)and maximum complications rate in group C(20%miosis,10%posterior capsular tears,5%zonular dialysis,5%cystoid macular edema).While best-corrected visual acuity(BCVA),intraocular pressure(IOP)and ECD did not show a significant difference among the three groups.CONCLUSION:Without prolonged surgery duration,the iris hook assistant method can minimize heat generation during surgery and incidence of complications,which transfer the challenged PE in vitrectomized eyes into a regular surgery.It does not need any change in the hydrodynamic parameters and in the bag PE technique,easy to operate even for junior surgeons.
文摘Dear Sir,It is known that cataract surgery is challenging in vitrectomized eyes.Cataract surgeons may have encountered with posterior capsular complications and nucleus drop events even with minimal ocular manipulations and low irrigation bottle height.Inadvertent damage to the zonular fibers,posterior or peripheral lens capsule with ocutome or microvitreoretinal(MVR)blade in previous
文摘Lee SM, Jung JW, Park SW, Lee JE, Byon IS. Retinal injury following intravitreal injection of a dexamethasone implant in a vitrectomized eye. Int J Ophthalmo12017; 10(6): 1019-1020
基金supported by the National Natural Science Foundation of China(Grant No.81000385)the Youth Science Foundation of Fujian Provincial Health Office(No.2010-2-119)
文摘Purpose:.To evaluate the efficacy and safety of using coreoplasty,.and an iris-supported Artisan intraocular lens (IOL), for mydriasis and aphakic correction in post-traumatic vitrectomized eyes. Methods:.A total of 17 aphakic patients were admitted between April 2009 and April 2010 to the ophthalmologic department of Xiamen Eye Centre..All eyes had previously received lens removal and vitrectomy. After the retina stabilized and corrected visual acuity improved,.the iris was sutured. The Artisan IOL was fixated onto the iris surface..Patients were followed-up at one day, one week,.one month and three months postoperatively..The following outcomes were assessed: symptoms of photophobia and glare, uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), intraocular pressure (IOP), endothelial cell density (ECD). The diameter of pupil and the anterior chamber depth (ACD) were measured by the anterior segment optical coherence tomography (OCT). Results:.Artisan IOLs were successfully implanted in all aphakic eyes. Postoperatively, improvement was observed in photophobia and glare symptoms..UCVA was enhanced in all patients.(six eyes had better UCVA postoperatively than BCVA preoperatively)..However,.there were no significant changes in IOP. Mean loss of ECD was 336.06/mm2. Mean postoperative pupil diameter was 3.67±0.41 mm, compared with 5.67±0.57 mm preoperatively(P<0.05). Mean ACD was reduced by 0.88 mm.(3.38±0.33 mm preoperatively vs 2.50±0.35 mm postoperatively, P<0.05). Conclusion:.Surgery that combined coreoplasty and Artisan IOL implantation was a safe and effective treatment for correcting aphakia and mydriasis in post-traumatic vitrectomized eyes.
文摘The glaucoma surgical landscape has changed dramatically over the last decade with the introduction and integration of micro-invasive glaucoma surgery(MIGS)techniques.These modalities target physiologic outflow pathways or optimize previously utilized glaucoma surgical methods in order to deliver safety,efficacy,and individualized care to the patient.MIGS techniques can be classified based on anatomical location as well as method of intraocular pressure(IOP)reduction.This review will focus on MIGS optimizing the conventional outflow pathway via intervention at Schlemm’s canal,MIGS optimizing the uveoscleral outflow pathway via suprachoroidal shunting,and MIGS optimizing the transscleral or subconjunctival outflow pathway which has long been utilized by glaucoma surgeons performing traditional filtration procedures.The wide array of currently available MIGS modalities can be staggering to the glaucoma care provider,but an understanding of the landscape and the large classes of interventional strategies can allow for clinical decision making based on the specifics of the patient’s needs and the pathophysiology of their disease.
基金Supported by the Funds of Shanghai Health Bureau(No. 2007156)
文摘Objective:To evaluate the clinical therapeutic effects of oral administration and external application of Chinese drugs combined with micro-invasive surgery for the treatment of varicose ulcers in the lower extremities(ecthyma).Methods:A total of 152 patients(163 limbs) suffering from varicose ulcers on the lower limbs were assigned to two groups according to the patients willingness.The 102 cases(109 limbs) in the treatment group underwent the method of endovenous microwave closure of communicating veins ...
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.
基金This study was funded by an investigator-initial trial grant from Glaukos Corp.(San Clemente,CA,USA).
文摘Background:Retrospective,consecutive case series to evaluate the implantation of two second-generation trabecular microbypass stents in combination with cataract surgery in a real-world,clinical setting.Methods:The series included 56 eyes implanted with the iStent inject device with phacoemulsification.The series consisted of eyes with primary open-angle glaucoma(n=52)and pseudoexfoliative glaucoma(n=4).Primary outcome measures included intraocular pressure(IOP)and number of glaucoma medications.Safety outcomes included the need for secondary surgical intervention and the incidence of IOP spikes≥10 mmHg and≥15 mmHg.Results:IOP was reduced by 21%to 14.7±2.9 mmHg(p<0.01)at 6 months postoperative from 18.7±5.8 mmHg at baseline.Preoperatively,the mean number of glaucoma medications was 1.5±0.9 and reduced by 39%to 0.9±1.2(p<0.01)at 6 months.At 6 months,68%of eyes had an IOP≤15 mmHg,increased from 30%at baseline.55%of eyes were medication-free at 6 months,up from 18%at baseline.There were no severe postoperative complications.No eyes underwent an additional glaucoma procedure.Conclusions:Implantation of the iStent inject device with concomitant cataract surgery effectively provides a sustained reduction in IOP with a markedly improved medication burden out to 6 months postoperative.The safety profile is excellent.
基金funded by an investigator-initial trial grant from Glaukos Corp.(San Clemente,6,USA).
文摘Background:Retrospective,consecutive case series to evaluate the implantation of two sec on d-generation trabecular microbypass stents in combination with cataract surgery in a real-world,clinical setting.Methods:The series in eluded 56 eyes implanted with the iSte nt inject device with phacoemulsification.The series consisted of eyes with primary open-angle glaucoma(n=52)and pseudoexfoliative glaucoma(n=4).Primary outcome measures included intraocular pressure(IOP)and number of glaucoma medications.Safety outcomes included the need for secondary surgical intervention and the incidence of IOP spikes>10 mmHg and>15 mmHg.Results:IOP was reduced by 21%to 14.7±2.9 mmHg(P<0.01)at 6 months postoperative from 18.7±5.8 mmHg at baseline.Preoperatively,the mean number of glaucoma medications was 1.5±0.9 and reduced by 39% to 0.9±1.2(P<0.01)at 6 months.At 6 months,68%of eyes had an IOP<15 mmHg,increased from 30%at baseline.55%of eyes were medicati on-free at 6 months,up from 18%at baseline.There were no severe postoperative complications.No eyes underwent an additional glaucoma procedure.Conclusions:Implantation of the iStent inject device with concomitant cataract surgery effectively provides a sustained reduction in IOP with a markedly improved medication burden out to 6 months postoperative.The safety profile is excellent.