Glaucoma Drainage Implants

青光眼引流植入物
  • 文章类型: Journal Article
    目的:描述使用闭合性结膜外途径双重植入Xen45凝胶支架(Xen)的结果。
    方法:回顾性单中心病例系列原发性开角型青光眼患者,在没有结膜开放的情况下,通过abexterno技术在同一只眼睛植入第二个Xen后,进行至少六个月的随访。
    结果:纳入8例患者的8只假晶状体眼。眼压(IOP)从术前的30±2.6mmHg下降到第一次Xen植入后一个月的22.4±2.3mmHg(平均差:-7.6mmHg[95%置信区间:-9.4,-5.9mmHg],p=0.0092)。然后植入第二个Xen以达到目标IOP。术中、术后无明显并发症。第二次植入后6个月,眼压降至16.1±2.7mmHg(平均差:-6.3mmHg[95%置信区间:-7.2,-5.3mmHg],p=0.0183);然而,3例患者需要药物治疗以进一步降低IOP至目标值。
    结论:在结膜闭合的情况下,使用abexterno方法序贯植入两个Xen45凝胶支架似乎是一个有希望的手术,在这个小病例系列中显示出良好的安全性和有效性。该试验数据可能为进一步研究以评估该程序的安全性和有效性铺平道路。
    OBJECTIVE: To describe the outcomes of double implantation of Xen 45 Gel Stent (Xen) using an ab externo approach with closed conjunctiva.
    METHODS: Retrospective single-centre case series of primary open-angle glaucoma patients with at least six months of follow-up after implantation of a second Xen in the same eye via ab externo technique without conjunctival opening.
    RESULTS: Eight pseudophakic eyes of 8 patients were included. Intraocular pressure (IOP) dropped from 30 ± 2.6 mmHg pre-operatively to 22.4 ± 2.3 mmHg one month after the first Xen implant (mean difference: -7.6 mmHg [95% confidence interval: -9.4, -5.9 mmHg], p = 0.0092). A second Xen was then implanted to achieve the target IOP. The procedure showed no significant intraoperative or postoperative complications. The IOP dropped to 16.1 ± 2.7 mmHg six months following this second implant (mean difference: -6.3 mmHg [95% confidence interval: -7.2, -5.3 mmHg], p = 0.0183); however, 3 patients needed medical therapy to further reduce the IOP towards the target value.
    CONCLUSIONS: Sequential implantation of two Xen 45 Gel Stents using an ab externo approach with closed conjunctiva appears a promising procedure that showed a favorable safety and efficacy profile in this small case series. This pilot data might pave the way for further studies to evaluate the safety and efficacy of the procedure.
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  • 文章类型: Journal Article
    这项研究旨在比较独立PreservfloMicroShunt和iStent第一代植入联合超声乳化术在12个月随访期的高加索患者中降低IOP的有效性和安全性。这项回顾性研究分析了在眼科接受抗青光眼手术的患者的病史,比亚韦斯托克医科大学,2019年1月至2022年1月。主要结局指标是成功率(完整:IOP<18mmHg(标准A)和<15mmHg(标准B)的眼睛比例或在没有任何青光眼药物的情况下IOP降低20%;合格:IOP<18mmHg和<15mmHg的眼睛比例或在有或没有药物的情况下IOP从基线降低20%),平均眼压下降(%),药物负担,并发症的数量和额外的干预措施。在这两组中,与基线相比,在6个月和12个月时观察到IOP和药物负担显著降低.12个月时,在Preservfo和iStent组中,有67.4%和85.7%的患者在标准A中记录了合格的手术成功率,分别(p=0.045)。在12个月时,标准B的手术成功率占Prserflo组患者的61.4%,iStent组患者的32.7%(p=0.04)。12个月时手术失败的患者分别为30.2%和6.3%,分别(p=0.003)。12个月后,两组之间的眼压降低百分比存在显着差异。在Preservflo组中观察到更大的减少,MD=-8.41CI95[-15.88;-0.95],p=0.028,(-33.49%±21.59vs.iStent组-25.07%±14.15)。两种方法均有效降低了青光眼患者的眼压和术后抗青光眼药物的使用。
    This study aimed to compare the IOP-lowering effectiveness and safety of standalone Preserflo MicroShunt and iStent 1st generation implantation combined with phacoemulsification in Caucasian patients with a 12-month follow-up period. This retrospective study analyzed the medical histories of patients undergoing antiglaucoma surgery at the Department of Ophthalmology, Medical University of Bialystok, between January 2019 and January 2022. The main outcome measures were success rates (complete: proportion of eyes with IOP < 18 mmHg (criterion A) and < 15 mmHg (criterion B) or 20% reduction in IOP without any glaucoma medication; qualified: proportion of eyes achieving IOPs < 18 mmHg and < 15 mmHg or 20% reduction in IOP from baseline with or without medications), mean reduction (%) in IOP, medication burden, number of complications and additional interventions. In both groups, a significant decrease in IOP and medication burden were observed at 6 and 12 months when compared with baseline. At 12 months, qualified surgical success in criterion A was recorded in 67.4% and 85.7% of patients in the Preserfo and iStent groups, respectively (p = 0.045). Complete surgical success in criterion B at 12 months accounted to 61.4% of patients from Prserflo group and 32.7% patients in iStent group (p = 0.04). Surgical failure at 12 months was documented in 30.2% and 6.3% of patients, respectively (p = 0.003). There was a significant difference between groups in %IOP reduction after 12 months. Greater reduction was observed in Preserflo group, MD = - 8.41 CI95 [- 15.88; - 0.95], p = 0.028, (- 33.49% ± 21.59 vs - 25.07% ± 14.15 in iStent group). Both procedures effectively reduced IOP and postoperative use of antiglaucoma medications in glaucoma patients.
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  • 文章类型: English Abstract
    Objective: To evaluate the efficacy and safety of glaucoma drainage implants(XEN-45 Gel Stent) for glaucoma treatment. Methods: A prospective study was conducted to continuously collect the clinical data of patients who were diagnosed with glaucoma and underwent XEN-45 Gel Stent implantation in the Ophthalmology Department of Peking University People\'s Hospital from January 2022 to August 2023. The visual acuity, intraocular pressure, number of glaucoma medications, and success rate of the patients were analyzed before and after surgery at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months, and 18 months. The differences in intraocular pressure and number of glaucoma medications among primary open-angle glaucoma, primary angle closure glaucoma, secondary glaucoma, and different implantation methods of XEN-45 Gel Stent among patients with primary open-angle glaucoma were compared. The intraoperative and postoperative complications were observed, and the risk factors for needling and surgical complete success were analyzed. Results: A total of 48 eyes from 48 patients were included in this study, comprising 27 males and 21 females, with a mean age of (54.4±18.0) years and the disease duration was 36.0(7.3, 81.0) months.There were 28 cases of primary open-angle glaucoma, 4 cases of primary angle closure glaucoma, and 16 cases of secondary glaucoma.The follow-up period was 8.0 (3.0, 12.0) months. At 12 months after surgery, the intraocular pressure decreased from 20.5 (17.0, 26.0) mmHg to (13.5±3.3) mmHg (P<0.05), and the number of glaucoma medications decreased from 3.0 (3.0, 4.0) to 0.0 (0.0, 0.0) (P<0.05). The complete success rate and qualified success rate were 73.9% (17/23) and 91.3% (21/23), respectively. The most common postoperative complications were shallow anterior chamber in 6 cases (12.5%), hypotony in 3 cases (6.3%), and blocked stent in 3 cases (6.3%). The most common postoperative treatment was needling in 27 cases (56.3%). There was no significant difference in intraocular pressure among different types of glaucoma. In the comparison of postoperative effects of different surgical implantation methods for primary open-angle glaucoma, there were no statistically significant differences in intraocular pressure and the number of glaucoma medications at other follow-up time points except 1 month after surgery (P<0.05). Univariate logistic regression analysis did not find any risk factors associated with needling and surgical complete success. Conclusions: XEN-45 Gel Stent implantation is an effective and safe surgical option for different types of glaucoma patients in China, which can significantly reduce intraocular pressure and the use of glaucoma medications and has a high success rate. However, some patients may need needling or other treatments after surgery.
    目的: 评估青光眼引流管(XEN-45凝胶引流管)治疗青光眼的有效和安全性。 方法: 前瞻性研究。连续纳入从2022年1月至2023年8月于北京大学人民医院眼科被诊断为青光眼且行XEN-45凝胶引流管植入术的患者。收集患者术前及术后1 d、1周、1个月、3个月、6个月、12个月、18个月的视力、眼压、降眼压用药药物数量以及手术成功率情况,并比较原发性开角型青光眼(POAG)、原发性闭角型青光眼(PACG)、继发性青光眼(SG)3种类型青光眼各项指标,以及不同XEN-45凝胶引流管植入方式的POAG患眼手术前后眼压和降眼压用药药物数量的差异。观察患者术中和术后的并发症,采用单因素Logistic回归的方法分析针拨滤过泡及手术完全成功的相关因素。 结果: 共纳入青光眼患者48例(48只眼),包括男性27例、女性21例;年龄为(54.4±18.0)岁;病程为36.0(7.3,81.0)个月。其中POAG 28只眼、PACG 4只眼、SG 16只眼。随访8.0(3.0,12.0)个月。术后12个月时,其术前眼压由20.5(17.0,26.0)mmHg(1 mmHg=0.133 kPa)下降至(13.5±3.3)mmHg(P<0.05),降眼压用药药物数量由3.0(3.0,4.0)种减少至0.0(0.0,0.0)种(P<0.05),完全成功率、条件成功率分别为73.9%(17/23)和91.3%(21/23)。术后常见并发症为浅前房6例(12.5%),其次有一过性低眼压(<6 mmHg)3例(6.3%)、内口阻塞3例(6.3%),最常见的并发症处理为针拨滤过泡27例(56.3%)。不同青光眼类型在XEN-45凝胶引流管植入术后眼压的差异无统计学意义(P>0.05);在原发性开角型青光眼使用不同手术植入方法的术后效果比较中,除术后1个月时眼压差异存在统计学意义(P<0.05)外,其他随访时间点的眼压和降眼压用药药物数量的差异均无统计学意义(P>0.05)。未发现与针拨滤过泡及手术完全成功相关的危险因素。 结论: XEN-45 凝胶引流管植入术对于我国不同青光眼类型患者是一种有效且安全的手术方式,可以显著降低眼压和降眼压用药药物数量,且具有较高的手术成功率,但部分患者术后可能需要针拨滤过泡等处理。.
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  • 文章类型: Letter
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  • 文章类型: Journal Article
    目的:评估组织厚度的变化,特别是心包贴片移植物(PPG)覆盖在Ahmed青光眼瓣膜(AGV)手术中的硅胶管。
    方法:前瞻性观察性研究。
    方法:本研究纳入了难治性青光眼患者,这些患者接受了PPG覆盖的AGV植入术。结膜上皮,在1,6和12个月时使用眼前节光学相干断层扫描(AS-OCT)测量基质和覆盖管的PPG厚度.此外,相同的测量值在距离管1500µm处进行,作为中央测量的对照。
    结果:研究中评估了27例患者的27只眼。尽管两个区域的PPG厚度都显着下降,减少量在中央更为明显。中央,在1-6个月和6-12个月期间,减少率分别为21.2%和34.8%,而外周是3.5%和5.1%,分别。在随访期间,未观察到上皮厚度的变化。在1-6个月期间,中心和外围区域的基质明显变薄(30.5%和17%,分别)。在随访期间未观察到暴露病例。
    结论:尽管在术后早期观察到覆盖管的层最明显的变薄,即使在后期,PPG也显示出稳定的下降。在外围区域中也观察到的PPG厚度的逐渐减小表明除了机械力之外的因素有助于该退化过程。AS-OCT可能是阐明这一过程的有价值的非侵入性工具。
    OBJECTIVE: To evaluate the changes in thickness of tissues, specifically the pericardium patch graft (PPG) covering the silicone tube in Ahmed Glaucoma Valve (AGV) surgery.
    METHODS: Prospective observational study.
    METHODS: This study included cases with refractory glaucoma that underwent AGV implantation with PPG coverage. Conjunctival epithelium, stroma and PPG thickness covering the tube were measured using anterior segment optical coherence tomography (AS-OCT) at 1, 6 and 12 months. Additionally, the same measurements were taken 1500 µm away from the tube as a control for the central measurements.
    RESULTS: Twenty-seven eyes of 27 patients were evaluated in the study. Although PPG thickness decreased significantly in both regions, the amount of reduction was more pronounced centrally. Centrally, the reduction rate was 21.2% and 34.8% during the 1-6 months period and 6-12 months period, while peripherally it was 3.5% and 5.1%, respectively. No change was observed in the thickness of the epithelium during the follow-up period. There was a significant thinning of the stroma in the central and peripheral regions during the 1-6 months period (30.5% and 17%, respectively). No cases of exposure were observed during the follow-up period.
    CONCLUSIONS: Although the most evident thinning of the layers covering the tube was observed in the early postoperative period, PPG showed a stable decrease even in the late period. The progressive reduction in the PPG thickness observed also in the peripheral region indicates that factors beyond mechanical forces contribute to this degenerative process. AS-OCT could be a valuable non-invasive tool in clarifying this process.
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  • 文章类型: Journal Article
    目的:评估和比较青光眼引流装置(GDD)植入术与传统的丝裂霉素小梁切除术治疗青光眼后发生囊样黄斑水肿(CME)的风险。
    方法:回顾性回顾2016年至2018年期间接受trab或GDD植入的连续患者。纳入标准是黄斑术前和术后谱域光学相干断层扫描(SD-OCT)的可用性。对SD-OCT图像是否存在CME进行定性评估,中心子场厚度(CST)和黄斑体积(MV)。
    结果:可以包括73只眼睛,42例接受trab和31例GDD手术。接受trab的眼睛平均有0.8±0.8以前的眼内手术,而植入GDD的眼睛为3.1±1.9(p<0.001)。术后CME的发生在GDD植入术后(31只中的6只(19.4%))明显高于trab术后(42只眼中的2只=4.8%),(p=0.049)。两组的术前平均CST和MV均具有可比性(trab前的CST:282.7±23.0µm,GDD前CST284.2±27.3µm,p=0.287;trab前MV:7.8±1.1mm3,GDD前MV:8.0±0.8mm3,p=0.305)。GDD后,术后平均CST和MV显着升高(CST338.5±129.3µm,MV8.8±2.6mm3),高于小梁切除术后(CST290.6±60.2µm,p=0.038;MV7.8±1.2mm3,p=0.039)。
    结论:在现实生活中,与传统小梁切除术相比,GDD手术似乎与发生CME的风险更高。这些信息可能有助于青光眼外科医生建议患者术后手术风险。
    OBJECTIVE: To assess and compare the risk for development of cystoid macula edema (CME) after glaucoma drainage device (GDD) implantation versus conventional trabeculectomy with mitomycin (trab) for glaucoma.
    METHODS: Retrospective review of consecutive patients receiving trab or GDD implantation between 2016 and 2018. Inclusion criteria were availability of pre- and postoperative spectral domain optical coherence tomography (SD-OCT) of the macula. SD-OCT images were evaluated for presence of CME qualitatively, central subfield thickness (CST) and macular volume (MV).
    RESULTS: 73 eyes could be included, 42 received trab and 31 GDD surgery. Eyes receiving trab on average had 0.8 ± 0.8 previous intraocular operations, while eyes with GDD implantation had 3.1 ± 1.9 (p < 0.001). Occurrence of postoperative CME was significantly more frequent after GDD implantation (6 out of 31 (19.4%)) than after trab (2 out of 42 eyes = 4.8%), (p = 0.049). Mean preoperative CST as well as MV was comparable in both groups (CST before trab: 282.7 ± 23.0 µm, CST before GDD 284.2 ± 27.3 µm, p = 0.287; MV before trab: 7.8 ± 1.1 mm3, MV before GDD: 8.0 ± 0.8mm3, p = 0.305). Mean postoperative CST and MV were significantly higher after GDD (CST 338.5 ± 129.3 µm, MV 8.8 ± 2.6 mm3) than after trabeculectomy (CST 290.6 ± 60.2 µm, p = 0.038; MV 7.8 ± 1.2mm3, p = 0.039).
    CONCLUSIONS: In real-life conditions, GDD surgery seems to be associated with a higher risk to develop CME when compared to conventional trabeculectomy. This information may be helpful for glaucoma surgeons to advise the patients on postoperative risks of surgery.
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  • 文章类型: Journal Article
    目的:青光眼研究员对Ahmed青光眼阀(AGV)植入手术技术的教学和培训非常重要。这项研究的目的是描述来自印度东部三级眼科中心的青光眼研究员进行AGV手术的临床结果和并发症。
    方法:这是一项基于电子病历的回顾性研究。包括2016年1月至2020年11月由五名青光眼研究员用AGV手术的35只眼。最佳矫正视力,眼内压(IOP),和抗青光眼药物(AGM)的数量是研究结果指标。
    结果:患者的平均(±标准差)年龄为40.5(±19.7)岁。随访时间为24.37(±13.01)个月。在八只眼(22.8%)中,获得了完全成功(IOP<21mmHg,没有额外的AGM)和合格成功(IOP<21mmHg,有额外的AGM)。在19只眼(54.3%)中发现手术失败,因为在12只眼中需要重复手术以控制IOP,并且在7只眼中需要持续IOP峰值(IOP>21mmHg,AGM超过3个月)。尽管初级手术的失败率很高,在顾问的干预下,末次随访时,所有患者的视力和眼压均有统计学意义(P<0.01)。
    结论:AGV植入术是青光眼研究员获得的一项具有挑战性的手术技巧。
    OBJECTIVE: Teaching and training of glaucoma fellows on the technique of Ahmed glaucoma valve (AGV) implantation surgery is very important. The purpose of this study was to describe the clinical outcomes and complications of AGV surgery performed by glaucoma fellows of a tertiary eye center from eastern India.
    METHODS: This was a retrospective study based on electronic medical records. Thirty-five eyes operated with AGV by five glaucoma fellows from January 2016 to November 2020 were included. Best-corrected visual acuity, intraocular pressure (IOP), and number of antiglaucoma medications (AGMs) were the study outcome measures.
    RESULTS: The mean (±standard deviation) age of the patients was 40.5 (±19.7) years. The follow-up period was 24.37 (±13.01) months. Both complete success (IOP <21 mmHg without additional AGM) and qualified success (IOP <21 mmHg with an additional AGM) were achieved in eight eyes each (22.8%). Failure of the surgery was noted in 19 eyes (54.3%) as there was a need for repeat surgery for IOP control in 12 eyes and a persistent IOP spike (IOP >21 mmHg with AGM beyond 3 months) in seven eyes. Despite a high rate of failure of the primary surgery, with the consultants\' intervention, there was statistically significant improvement in vision and IOP in all patients ( P < 0.01) at the last follow-up.
    CONCLUSIONS: AGV implantation is a challenging surgical skill to be acquired by the glaucoma fellows.
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  • 文章类型: Journal Article
    背景:新生血管性青光眼(NVG)是继发性青光眼,视力预后较差。使用抗纤维化药物的小梁切除术,青光眼引流装置(GDD),对于难以接受医疗管理的患者,建议使用循环破坏程序。然而,由于传统小梁切除术的成功率较低,GDD的成本较高,需要考虑替代程序。
    目的:比较新开发的基于聚丙烯缝合床的改良小梁切除术与Ahmed青光眼阀(AGV)植入NVG的手术效果和经济方面。
    方法:这是一项前瞻性干预研究,于2018年至2020年在三级护理中心进行。纳入了至少18个月随访的连续NVG患者。手术结果主要取决于眼内压(IOP)控制和手术费用。
    结果:共60只眼,其中40只眼(60.6%)行改良小梁切除术,20只眼(33.7%)行AGV。在最后的后续行动中,两组患者的手术结局差异无统计学意义(P<0.05)。改良小梁切除术和AGV组的完全成功率(眼压<21mmHg,不使用抗青光眼药物)分别为60%和65%,而合格成功率(使用抗青光眼药物的眼压<21mmHg)分别为30%和25%。分别,在最后的后续行动。AGV组的手术费用明显较高(P<0.0001)。
    结论:所描述的改良小梁切除术可能是NVG眼的更好选择。
    BACKGROUND: Neovascular glaucoma (NVG) is a secondary glaucoma with a poor visual prognosis. Trabeculectomy with antifibrotic agents, glaucoma drainage devices (GDDs), and cyclo-destructive procedures are recommended in patients who are refractory to medical management. However, due to the poor success rate of conventional trabeculectomy and the higher cost of GDDs, alternative procedures need to be looked at.
    OBJECTIVE: To compare the surgical outcomes and economic aspects of a newly developed polypropylene suture bed-based modified trabeculectomy to Ahmed glaucoma valve (AGV) implantation for NVG.
    METHODS: It was a prospective interventional study conducted at a tertiary care center between 2018 and 2020. Consecutive patients with NVG with a minimum follow-up of 18 months were included. Surgical outcomes are mainly based on intraocular pressure (IOP) control and the cost of surgery.
    RESULTS: Sixty eyes were included out of which 40 (60.6%) underwent modified trabeculectomy and 20 (33.7%) underwent AGV. At the final follow-up, no significant difference (P < 0.05) was found between the surgical outcomes of both groups. The complete success rate (IOP < 21 mm Hg without antiglaucoma medications) was 60 and 65% while the qualified success rate (IOP < 21 mm Hg with antiglaucoma medications) was 30 and 25% in modified trabeculectomy and AGV groups, respectively, at final follow-up. The cost of surgery was significantly higher in the AGV group (P < 0.0001).
    CONCLUSIONS: Modified trabeculectomy as described might be a better alternative for NVG eyes.
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  • 文章类型: Journal Article
    目的:评估联合白内障手术的有效性和安全性,并插入ab间小梁微旁路装置(iStentInject,GlaukosCorporation)与轻度至中度青光眼患者的单独白内障手术相比。
    方法:前瞻性,随机化,单中心的评估者蒙面对照试验。
    方法:眼睛有视觉意义的白内障和轻度至中度青光眼,术前眼压(IOP)为12-30mmHg,使用0至3种眼压药物。
    方法:参与者的眼睛被随机分配(2017-2020年)1:1接受白内障手术联合支架注射(治疗组,n=56)或单独进行白内障手术(对照组,n=48),并跟踪了两年。
    方法:共同主要有效性终点是术后24个月时的眼压和眼压。次要有效性终点是通过眼表疾病指数(OSDI)测量的眼部舒适度和通过24个月的青光眼活动限制问卷(GAL-9)测量的与视觉相关的生活质量。安全措施包括术后视力、任何计划外的返回手术室,不良事件,和并发症。
    结果:参与者(67.3%为男性)年龄在53-85岁之间,治疗组的平均药物IOP相似(治疗组17.7mmHg±4.0;对照组17.1mmHg±3.1),和基线时的低眼压药物数量(治疗组1.69±1.05;对照组1.80±1.22)。24个月时,治疗组的降眼压药物数量为0.7±0.9,而对照组为1.5±1.9,校正后的差异为治疗组的每只眼用药减少0.6(95%CI0.2~1.1,p=0.008).治疗组中57%的眼睛没有使用青光眼药物,而对照组为36%。在4周之后,两组之间的IOP没有显着差异。两组患者报告的结果没有差异。两组的视觉结果和安全性相似。
    结论:与单纯白内障手术相比,联合白内障手术与iStent注射在24个月时在临床上和统计学上显著降低了眼压药物的使用。眼压无显著差异。
    OBJECTIVE: To evaluate the efficacy and safety of combined cataract surgery with insertion of an ab interno trabecular microbypass device (iStent Inject, Glaukos Corporation) compared to cataract surgery alone in patients with mild-to-moderate glaucoma.
    METHODS: Prospective, randomized, assessor-masked controlled trial at a single centre.
    METHODS: Eyes with visually-significant cataract and mild-to-moderate glaucoma with preoperative intraocular pressure (IOP) of 12 to 30 mmHg on 0 to 3 ocular hypotensive medications.
    METHODS: Participants eyes were randomized (2017-2020) 1:1 to combined cataract surgery with iStent Inject (treatment group, n = 56) or cataract surgery alone (control group, n = 48), and followed up for 2 years.
    METHODS: The co-primary effectiveness endpoints were the number of ocular hypotensive medications and IOP at 24-months post-surgery. The secondary effectiveness endpoints were ocular comfort as measured by the Ocular Surface Disease Index (OSDI) and vision-related quality of life as measured by the Glaucoma Activity Limitation Questionnaire (GAL-9) at 24-months. Safety measures included postoperative visual acuity, any unplanned return to the operating theatre, adverse events, and complications.
    RESULTS: Participants (67.3% male) were aged 53 to 85 years, and treatment groups were similar in terms of mean medicated IOP (treatment group 17.7 mmHg ± 4.0; control group 17.1 mmHg ± 3.1), and number of ocular hypotensive medications (treatment group 1.69 ± 1.05; control group 1.80 ± 1.22) at baseline. At 24 months, the number of ocular hypotensive medications were 0.7 ± 0.9 in the treatment groups compared to 1.5 ± 1.9 in the control group, with an adjusted difference of 0.6 fewer medications per eye in the treatment group (95% CI 0.2-1.1, P = 0.008). In the treatment group, 57% of eyes were on no glaucoma medications compared to 36% in the control group. There was no significant difference in IOP between the 2 groups beyond the 4-weeks. There were no differences in patient-reported outcomes between the 2 groups. The visual outcomes and safety profiles were similar between the 2 groups.
    CONCLUSIONS: Combined cataract surgery with iStent Inject achieved a clinically- and statistically-significantly greater reduction in ocular hypotensive medication usage at 24-months compared to cataract surgery alone, with no significant difference in IOP.
    BACKGROUND: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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  • 文章类型: Journal Article
    目的:关于一般青光眼治疗和早期微创和微切口手术的建议是有限的。这项研究旨在建立关于青光眼管理的共识,专注于XEN-45凝胶支架植入。
    方法:使用Delphi共识驱动过程。科学委员会领导了这项研究,确定了专家小组,并参与制定问卷。51名小组成员被邀请完成,在李克特的九分尺度上,包含三个主题块的89项问卷。进行了两轮Delphi。如果≥66.6%的小组成员达成一致或分歧,则达成共识。
    结果:小组成员就84个与患者生活质量相关的项目达成一致,治疗算法和患者概况,以及手术和手术前后的管理。小组成员同意XEN支架植入物在不同阶段和不同患者情况下治疗青光眼的适用性:年轻患者,老年人或有明显合并症,患有近视性青光眼,以前手术失败的病人,和以前可怜的术后经验。XEN手术被认为是经典滤过手术之前的治疗步骤,并且是合并疾病和不受控制的眼压的老年患者的可能的第一手术选择。XEN手术使患者能够比常规过滤手术更快地恢复日常活动,并减少和/或消除局部治疗。
    结论:这个德尔菲驱动的共识产生了一系列青光眼治疗的一般建议,包括那些与患者生活质量有关的,治疗算法,和病人资料,以及关于XEN支架凝胶手术的具体使用。
    OBJECTIVE: Recommendations on general glaucoma management and the use of early minimally invasive and microincisional surgeries are limited. This study aimed to establish consensus regarding glaucoma management, focusing on the XEN-45 gel stent implant.
    METHODS: A Delphi consensus-driven process was used. The scientific committee led the study, identified the expert panel, and participated in elaborating the questionnaire. Fifty-one panelists were invited to complete, on a nine-point Likert scale, an 89-item questionnaire covering three topic blocks. Two Delphi rounds were performed. Consensus was achieved if ≥66.6% of panelists reached agreement or disagreement.
    RESULTS: Panelists agreed on 84 items related to the patients\' quality of life, the therapeutic algorithm and patient profile, and surgical and pre- and post-operative management. Panelists agreed on the suitability of XEN stent implants to treat glaucoma at different stages and for different patient profiles: young patients, elderly or with significant comorbidities, and with myopic glaucoma, patients who failed previous surgeries, and with previous poor post-operative experience. XEN surgery was considered a therapeutic step prior to classic filtering surgery and a possible first surgical option in elderly patients with comorbidities and uncontrolled intraocular pressure. XEN surgery allows the patient to return to routine daily activities faster than conventional filtering surgeries and to reduce and/or eliminate topical treatments.
    CONCLUSIONS: This Delphi-driven consensus resulted in a series of general recommendations for glaucoma management, including those related to patient quality of life, therapeutic algorithm, and patient profile, and specific ones regarding the use of XEN stent gel surgery.
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