背景:这项研究报告了单小梁微旁路支架的长期眼内压(IOP)降低疗效和安全性(iStent®;GlaukosCorp.,圣克莱门特,CA,美国)用于韩国患者的药物控制的开角型青光眼。
方法:这项回顾性观察研究包括35例原发性开角型青光眼(POAG)患者的42只眼。所有受试者均由一名外科医生进行单次第一代iStent®植入和超声乳化术,随访5年。主要结果是与术前值相比,眼压和抗青光眼药物数量的变化。次要结果是未用药眼压≤18mmHg的眼睛比例,不用药≤15mmHg,且≤18mmHg,有或没有药物治疗。还记录了不良事件和继发性青光眼手术的需要。
结果:平均眼压从15.8±2.8下降到13.8±1.7mmHg,平均用药次数从2.24±1.18下降到0.83±1.12,在5年。在3年和5年,眼睛的80.6%和78.6%,分别,接受的药物数量少于术前。相比之下,在使用四种术前药物治疗的患者中,仅有50%的患者在5年时出现药物减少.在第3年和第5年,61.3%和53.5%的眼睛在没有药物治疗的情况下达到IOP≤18mmHg,而无论使用何种药物,90.3%和89.3%的眼睛达到≤18mmHg,分别。四只眼睛需要额外的青光眼手术(两次Ahmed青光眼阀植入,一次小梁切除术,和一个XEN45凝胶支架植入),所有患者均接受了四种术前抗青光眼药物治疗。短暂性眼压升高(14.3%)是最常见的并发症,接着是五个前房积血,一个支架阻塞,一个支架错位,和一次严重的前房反应.
结论:这项研究证明了在韩国患者中植入单小梁微旁路支架(iStent®)并进行超声乳化手术后具有良好的安全性和持续的眼压降低。大多数患有POAG的受试者表现出相对较好的反应;然而,术前接受更多药物(尤其是4种药物)的眼睛很难达到低目标IOP.
BACKGROUND: This study reports the long-term intraocular pressure (IOP)-lowering efficacy and safety of a single trabecular microbypass stent (
iStent®; Glaukos Corp., San Clemente, CA, USA) for medically controlled open-angle glaucoma in Korean patients.
METHODS: This retrospective observational study included 42 eyes of 35 patients with primary open-angle glaucoma (POAG). All subjects underwent single first-generation
iStent® implantation with phacoemulsification by a single surgeon with 5 years follow-up. The primary outcomes were changes in IOP and the number of antiglaucoma medications compared to the preoperative values. The secondary outcome was the proportion of eyes with IOP ≤ 18 mmHg without medication, ≤ 15 mmHg without medication, and ≤ 18 mmHg with or without medication. Adverse events and need for secondary glaucoma surgery were also recorded.
RESULTS: The mean IOP decreased from 15.8 ± 2.8 to 13.8 ± 1.7 mmHg and the mean number of medications was reduced from 2.24 ± 1.18 to 0.83 ± 1.12, respectively, at year 5. At 3 and 5 years, 80.6% and 78.6% of eyes, respectively, were receiving fewer medications than preoperative numbers. In contrast, only 50% of eyes on four preoperative medications showed medication reductions at 5 years. At years 3 and 5, 61.3% and 53.5% of eyes achieved IOP ≤ 18 mmHg without medication, whereas 90.3% and 89.3% of eyes achieved ≤ 18 mmHg regardless of medication use, respectively. Four eyes required additional glaucoma surgery (two Ahmed glaucoma valve implantations, one trabeculectomy, and one XEN 45 Gel Stent implantation), and all were receiving four preoperative antiglaucoma medications. Transient IOP elevation (14.3%) was the most common complication, followed by five hyphema, one stent obstruction, one stent malposition, and one severe anterior chamber reaction.
CONCLUSIONS: This study demonstrated a good safety profile and sustained IOP reduction after the implantation of a single trabecular microbypass stent (
iStent®) with phacoemulsification in Korean patients. The majority of subjects with POAG showed a relatively good response; however, eyes receiving a higher number of medications preoperatively (especially four medications) had difficulty achieving a low target IOP.