小梁微型旁路支架iStent的研究进展

随着人们对青光眼认识和研究的深入,抗青光眼手术方式也有了飞速的发展。小梁微型旁路支架iStent植入是近年来开始应用于临床的一种新型的微创青光眼手术,与传统的小梁切除术相比,手术安全、创伤小、恢复快、并发症小,而且不影响再次行常规的小梁切除术。本文就近年报道的关于小梁微型旁路支架iStent的研究进展进行综述。

Performances of glaucoma operations with Kahook Dual Blade or iStent combined with phacoemulsification in Japanese open angle glaucoma patients

AIM:To compare surgical outcomes of phacoemulsification combined with glaucoma surgical techniques performed with either Kahook Dual Blade(KDB)or iStent for Japanese patients with either primary open angle glaucoma or exfoliation glaucoma.METHODS:We retrospectively evaluated the surgical outcomes of 129 eyes of 84 Japanese patients with glaucoma who underwent KDB or 44 eyes of 34 patients who underwent phacoemulsification with iStent procedures combined with cataract surgery.The primary outcome was surgical success or failure[with surgical failure being indicated by<20%reduction from preoperative intraocular pressure(IOP)or IOP>18 mm Hg as criterion A;IOP>14 mm Hg as criterion B on two consecutive study visits;or reoperation requirement].In addition,we assessed the number of postoperative glaucoma medications and the resulting complications.RESULTS:The probability of success was significantly higher in the KDB group than in the iStent group for criterion A(60.2%vs 46.4%,P=0.019).In the KDB group,the mean preoperative IOP of 19.8±7.3 mm Hg decreased significantly to 13.0±3.1 mm Hg(P<0.01),and the mean number of glaucoma medications at 2.5±1.4 decreased significantly to 1.6±1.6(P<0.01)12 mo postoperatively.In the iStent group,the mean preoperative IOP of 17.8±2.9 mm Hg significantly decreased to 14.3±2.3 mm Hg(P<0.01),and the mean number of glaucoma medications at 2.2±1.1 decreased significantly to 0.9±1.4(P<0.01)12 mo postoperatively.The overall IOP reduction percentage was higher in the KDB group(26.2%)than in the iStent group(19.0%)12 mo postoperatively(P=0.03).Hyphema occurred significantly more frequently in the KDB group(16.3%)than in the iStent group(2.3%,P=0.017).CONCLUSION:KDB and iStent procedures combined with cataract surgery both result in significant IOP and glaucoma medication reductions after the 12-month followup.The patients in the KDB group have a higher success rate for the target IOP of less than 18 mm Hg and a higher complication rate than those in the iStent group.

iStent inject? and cataract surgery for mild-to-moderate primary open angle glaucoma in Japan: a cost-utility analysis

AIM: To evaluate the cost-utility of iStent inject;with cataract surgery vs cataract surgery alone in patients with mild-to-moderate primary open angle glaucoma(POAG) in the Japanese setting from a public payer’s perspective.METHODS: A Markov model was adapted to estimate the cost-utility of iStent inject;plus cataract surgery vs cataract surgery alone in one eye in patients with mild-tomoderate POAG over lifetime horizon from the perspective of Japanese public payer. Japanese sources were used for patients’ characteristics, clinical data, utility, and costs whenever available. Non-Japanese data were validated by Japanese clinical experts. RESULTS: In the probabilistic base case analysis, iStent inject;with cataract surgery was found to be cost-effective compared with cataract surgery alone over a lifetime horizon when using the ￥5 000 000/quality-adjusted life year(QALY)willingness-to-pay threshold. The incremental cost-utility ratio(ICUR) was estimated to be ￥1 430 647/QALY gained and the incremental cost-utility ratio(ICER) was estimated to be ￥12 845 154/blind eye avoided. iStent inject;with cataract surgery vs cataract surgery alone was found to increase costs(￥1 025 785 vs ￥933 759, respectively) but was more effective in increasing QALYs(12.80 vs 12.74) and avoiding blinded eyes(0.133 vs 0.141). The differences in costs were mainly driven by costs of primary surgery(￥279 903 vs ￥121 349). In the scenario analysis from a societal perspective, which included caregiver burden, iStent inject;with cataract surgery was found to dominate cataract surgery alone.CONCLUSION: The iStent inject;with cataract surgery is a cost-effective strategy over cataract surgery alone from the public payer’s perspective and cost-saving from the societal perspective in patients with mild-to-moderate POAG in Japan.

Micro-Invasive Glaucoma Surgery with the iStent inject: Impact on IOP and Medication Burden in a Real-World Setting

Background: The iStent inject is a Micro-Invasive Glaucoma Surgical (MIGS) device that has shown to reduce IOP and to be safe for glaucoma patients with fewer complications than regular surgery. Objective: To investigate, up to 15 - 20 months, the efficacy and safety of implantation of two second-generation trabecular microbypass stents in patients with or without prior glaucoma surgery. Methods: Fifty-seven eyes were implanted with the iStent inject. The population was comprised of eyes with primary open-angle glaucoma (n = 51), pseudoexfoliation glaucoma (n = 5) and ocular hypertension (n = 1). Major outcome parameters included IOP, medication needs and corrected distance visual acuity (CDVA). Follow-up time points were one day, 2 - 4 months, 9 - 14 months and 15 - 20 months. Results: The main reason to perform MIGS was IOP reduction in 68.4%, reduced number of medications due to drug intolerance in 24.6% and reduced medication due to compliance issues in 7.0% of the eyes. IOP decreased by 22.47%, from 19.40 ± 3.83 mmHg preoperatively (preop) to 15.04 ± 1.67 mmHg at 15-20 months postoperatively. IOP reduction was achieved at all follow-up time points (p Conclusions: Insertion of the iStent inject in patients with or without prior glaucoma surgery shows effective and sustained improvements in IOP with no safety concerns.

Long-term outcomes of two first-generation trabecular micro-bypass stents (iStent) with phacoemulsification in primary open-angle glaucoma: eight-year results

Background:The short-and medium-term outcomes of iStent have been extensively studied;however,only few studies have investigated its long-term outcomes.Here,we assessed the long-term efficacy and safety of two iStents with concomitant cataract surgery in glaucomatous eyes while also evaluating measures of disease stability using vis-ual field and optical coherence tomography(OCT)of the optic nerve and the macula throughout eight years of follow-up.Methods:This longitudinal,single-center consecutive case series included glaucomatous eyes that underwent implantation of two first-generation trabecular micro-bypass stents(iStent)with concomitant cataract surgery.Eight-year efficacy outcomes included mean intraocular pressure(IOP)and medications,as well as surgical success.Eight-year safety outcomes included best-corrected visual acuity(BCVA),visual field mean deviation(VF-MD),cup-to-disc ratio(CDR),retinal nerve fiber layer(RNFL)thickness,ganglion cell-inner plexiform layer(GC-IPL)thickness,and adverse events.Results:A total of 62 eyes with primary open-angle glaucoma(POAG)were included.At eight years postoperative,IOP reduced by 26%from 19.2±3.9 mmHg preoperatively to 14.2±2.4 mmHg(P<0.001),91.1%of eyes achieved IOP≤18 mmHg(vs.51.6%preoperatively),69.6%of eyes achieved IOP≤15 mmHg(vs.14.5%preoperatively),and 25%of eyes achieved 1OP≤12 mmHg(vs.1.6%preoperatively).Medication use decreased by 17.9%from 2.8±1.1 preoperatively to 2.3±1.2(P=0.018).Surgical success rate was 90%,as six eyes underwent subsequent glaucoma surgeries.Safety measures of BCVA,CDR,RNFL thickness and GC-IPL thickness remained stable through eight years postoperative.VF-MD remained stable until postoperative year five and subsequently progressed according to the natural history of glaucomatous disease.Conclusions:Implantation of two iStents with concomitant cataract surgery is an effective and safe treatment option for surgery-naive POAG eyes,evidenced by significant IOP and medication reductions,reasonable surgical suc-cess,and favorable safety outcomes,throughout the eight-year follow-up.Our data additionally support the efficacy of this combined procedure in stabilizing or slowing disease progression.

Long‑term outcomes of two first‑generation trabecular micro‑bypass stents(iStent)with phacoemulsification in primary open‑angle glaucoma:eight‑year results

Background:The short-and medium-term outcomes of iStent have been extensively studied;however,only few studies have investigated its long-term outcomes.Here,we assessed the long-term efficacy and safety of two iStents with concomitant cataract surgery in glaucomatous eyes while also evaluating measures of disease stability using visual field and optical coherence tomography(OCT)of the optic nerve and the macula throughout 8 years of follow-up.Methods:This longitudinal,single-center consecutive case series included glaucomatous eyes that underwent implantation of two first-generation trabecular micro-bypass stents(iStent)with concomitant cataract surgery.Eight-year efficacy outcomes included mean intraocular pressure(IOP)and medications,as well as surgical success.Eight-year safety outcomes included best-corrected visual acuity(BCVA),visual field mean deviation(VF-MD),cup-todisc ratio(CDR),retinal nerve fiber layer(RNFL)thickness,ganglion cell-inner plexiform layer(GC-IPL)thickness,and adverse events.Results:A total of 62 eyes with primary open-angle glaucoma(POAG)were included.At 8 years postoperative,IOP reduced by 26%from 19.2±3.9 mmHg preoperatively to 14.2±2.4 mmHg(P<0.001),91.1%of eyes achieved IOP≤18 mmHg(vs.51.6%preoperatively),69.6%of eyes achieved IOP≤15 mmHg(vs.14.5%preoperatively),and 25%of eyes achieved IOP≤12 mmHg(vs.1.6%preoperatively).Medication use decreased by 17.9%from 2.8±1.1 preoperatively to 2.3±1.2(P=0.018).Surgical success was 90%,as six eyes underwent subsequent glaucoma surgeries.Safety measures of BCVA,CDR,RNFL thickness and GC-IPL thickness remained stable through 8 years postoperative.VF-MD remained stable until postoperative year 5 and subsequently progressed according to the natural history of glaucomatous disease.Conclusions:Implantation of two iStents with concomitant cataract surgery is an effective and safe treatment option for surgery-naïve POAG eyes,evidenced by significant IOP and medication reductions,reasonable surgical success,and favorable safety outcomes,throughout the 8-year follow-up.Our data additionally supports the efficacy of this combined procedure in stabilizing or slowing disease progression.

微创青光眼手术的新进展

微创青光眼手术(micro invasive glaucoma surgery,MIGS)是新兴的一类青光眼手术,与传统小梁切除术相比,手术并发症相对少。MIGS按降眼压原理分为三类:减少房水生成术(如内窥镜下激光睫状体光凝术,高强度聚焦超声睫状体成形术),外引流手术(如EX-PRESS微型引流钉植入术,Schlemm管成形术),内引流手术(如小梁网微分流支架iStent植入术,内路小梁消融术)。本文将对近年MIGS的优缺点及适应证进行简单综述。

Implantation of trabecular micro-bypass stent using a novel “landing strip” technique

AIM：To describe a novel technique of creating a landing strip within the trabecular meshwork to guide trabecular micro-bypass stent（iStent） implantation in patients who underwent phacoemulsification.METHODS：Thirty-four eyes from 30 patients who underwent i Stent implantation after phacoemulsification from May 2014 to February 2015 were included in our retrospective study. All iStents were implanted via the ＂landing strip＂ technique. A 25-gauge microvitreoretinal blade was used to bisect the trabecular meshwork to less than 1 clock-hour, effectively creating a landing strip. The iStent applicator was pressed along the landing strip and then the stent was released into the trabecular meshwork. RESULTS：Of the 34 eyes with iStent implantation, 27（79.4%） eyes had primary open-angle glaucoma, 6（17.6%） eyes had pseudoexfoliation glaucoma, and 1（2.9%） eye had ocular hypertension. At 6-month follow-up（n=17）, the mean number of hypotensive medications decreased from 2.2±1.2 at baseline to 0.8±1.3（P=0.05） and mean intraocular pressure decreased from 19.7±4.1 mm Hg at baseline to 16.7±2.1 mm Hg（P=0.58）. Two eyes（5.9%） required subsequent trabeculectomy. CONCLUSION：The ＂landing strip＂ technique appears to be an effective way to assist with iS tent implantation.

Comparison of minimally invasive glaucoma surgery with trabecular micro-bypass stent and microhook ab interno trabeculotomy performed in conjunction with cataract surgery

AIM: To evaluate the effectuality and safety of cataract surgery combined with either ab interno trabeculotomy by the microhook(μLOT) or a single i Stent? trabecular bypass implantation(i Stent) in eyes with cataract and mild-tomoderate glaucoma. METHODS: This study enrolled subjects with mild-tomoderate open angle glaucoma with visually significant cataract who used two or more ophthalmic antiglaucoma agents between 60 and 90 y of age. Patients underwent cataract surgery cooperated with either implantation of an i Stent(i Stent-phaco) or excisional goniotomy with the μLOT(μLOT-phaco). Patients underwent μLOT-phaco in the eye with lower the mean deviation, according to the Humphrey field analyzer, while i Stent-phaco was carried out on the other eye. Intraocular pressure(IOP) pre-and post-surgery, alterations in anterior chamber flare(ACF), and corneal endothelial cell density(ECD) were estimated.RESULTS: Twenty subjects were enrolled(mean age: 73.6±7.3 y). The mean medicated preoperative IOP was 16.7 mm Hg in the μLOT and 16.2 mm Hg in the i Stent eyes. The mean final IOP at 12 mo was 13.6 mm Hg in the μLOT eyes and 13.6 mm Hg in the i Stent eyes, representing a 17.8% and 17.2% reduction, respectively. The preoperative ACF in the μLOT eyes was 9.5 pc/ms and it returned to normal in 30 d postoperatively, with a value of 11.4 pc/ms. In the i Stent eyes, ACF was 9.6 pc/ms preoperatively and it returned to normal by 7 d postoperatively(11.2 pc/ms atday 7), demonstrating that postoperative inflammation was less in the i Stent eyes. The corneal ECD in both groups was not significantly decreased.CONCLUSION: In this study, i Stent and μLOT are both effective through 12 mo of follow-up. Safety is more favorable in the i Stent eyes, based on early anterior chamber inflammation.

黄连温胆汤治疗幽门螺杆菌相关性胃炎临床观察

目的观察黄连温胆汤治疗幽门螺杆菌相关性胃炎Hp根除的临床疗效。方法选择接收的Hp感染慢性浅表性胃炎患者82例,纳入时间为2017年2月—2018年7月,采用随机数字表法将其分为实验组与对照组,每组均41例。对照组采用西药四联治疗,试验组行黄连温胆汤与四联联合治疗,对比2组患者症状积分、不良反应及Hp根除率。结果试验组胃脘胀痛、腹胀满、口苦、恶心呕吐、胃脘灼热、尿黄、口臭等症状积分均低于对照组,差异明显(P <0. 05)。2组患者便秘、腹泻、皮疹等不良反应发生率(9. 76%、7. 32%)未见明显差异(P> 0. 05)。试验组Hp根除率(87. 80%)明显高于对照组(65. 85%),差异有统计学意义(P <0. 05)。结论幽门螺杆菌感染所致慢性浅表性胃炎患者采用黄连温胆汤治疗效果显著,其安全性水平较高,应予以临床推广。

Second-generation trabecular micro-bypass stent implantation: Retrospective analysis after 12- and 24-month follow-up

Background:The study aimed to investigate the 24-month safety and efficacy of implantation of two secondgeneration iStent inject trabecular micro-bypass stents with concomitant cataract surgery.Methods:This consecutive case series included 164 eyes of 109 patients implanted with the iStent inject®device with concomitant cataract surgery.The series was comprised of eyes with primary open-angle glaucoma(n=84),pseudoexfoliation glaucoma(n=42),normal-tension glaucoma(n=18),and ocular hypertension(n=20).All 164 eyes reached 9–14 months of follow-up(“12-month consistent cohort”),with a subset of 88 eyes reaching 21–26 months of follow-up(“24-month consistent cohort”).Performance outcome measures included intraocular pressure(IOP)and number of glaucoma medications.Safety outcomes included intra-or postoperative complications,the need for secondary procedures and corrected distance visual acuity.Comparisons of change in continuous(e.g.,IOP)and categorical(e.g.,proportions of eyes on zero medications)measures between baseline and postoperative times were made with the paired t-test and McNemar’s chi-squared test,respectively.Results:At 12 months postoperatively,IOP was reduced by 25.5%(from 20.0±5.5 mmHg to 14.9±2.0 mmHg;p<0.001);at 24 months postoperatively,IOP was reduced by 26.6%(from 20.3±6.1 mmHg to 14.9±1.9 mmHg;p<0.001).At 12 months postoperatively,mean number of glaucoma medications was reduced by 85.0%(from 2.0±1.0 to 0.3±0.8 medications;p<0.001);at 24 months postoperatively,mean number of medications was reduced by 81.0%(from 2.1±1.1 to 0.4±0.8 medications;p<0.001).After 12 months,96.3%of eyes had an IOP≤18 mmHg and 58.5%of eyes had an IOP≤15 mmHg,with 81.1%of eyes free of any medication,compared to 1.8%of eyes medication-free in the 12-month cohort at baseline.After 24 months,98.9%of eyes had an IOP≤18 mmHg and 53.4%of eyes had an IOP≤15 mmHg,with 72.7%free of medication compared to 1.1%of eyes medication-free in the 24-month cohort at baseline.Overall,a high safety profile was observed with no significant postoperative complications.Conclusions:The insertion of iStent inject(comprised of two second-generation trabecular micro-bypass stents)with cataract surgery effectively provides a sustained reduction in IOP with a markedly improved medication burden up to 24 months postoperatively.