Long-term titrated IOP control with one, two, or three trabecular micro-bypass stents in open-angle glaucoma subjects on topical hypotensive medication: 42-month outcomes.
Long-term titrated IOP control with one, two, or three trabecular micro-bypass stents in open-angle glaucoma subjects on topical hypotensive medication: 42-month outcomes.
复制标题
DOI：
10.2147/opth.s152268
复制
发表时间：
2018
期刊：
影响因子：
--
通讯作者：
Hornbeak DM
中科院分区：
文献类型：
--
作者：
Katz LJ;Erb C;Carceller Guillamet A;Fea AM;Voskanyan L;Giamporcaro JE;Hornbeak DM
在接受眼部扩张药物治疗的开角型青光眼患者中，评价在独立手术中植入1个、2个或3个小梁微旁路支架后的长期结局。一项正在进行的前瞻性随机研究，纳入119例开角型青光眼受试者（109例随访42个月），术前眼内压（IOP）18-30 mmHg，使用1 - 3种青光眼药物，未用药（洗脱后）IOP 22-38 mmHg。受试者在独立手术中随机接受1枚（n=38）、2枚（n=41）或3枚（n=40）iStent小梁微旁路支架。术后，用药物测量IOP，并在洗脱后每年测量一次。数据包括IOP、药物、前房角镜检查、角膜厚度测量、视野、视力、不良事件、裂隙灯和眼底检查。术前平均用药IOP为19.8±1.3 mmHg（单支架眼使用1.71种药物）、20.1±1.6 mmHg（双支架眼使用1.76种药物）和20.4±1.8 mmHg（三支架眼使用1.53种药物）。三组支架植入前的洗脱后IOP分别为25.0±1.2、25.0±1.7和25.1±1.9 mmHg。术后42个月，三组的药物IOP分别为15.0±2.8、15.7±1.0和14.8±1.3 mmHg，洗脱后IOP（36-37个月）分别为17.4±0.9、15.8±1.1和14.2±1.5 mmHg。在第12个月时，在不使用药物的情况下，分别有89%、90%和92%的单支架、双支架和三支架眼实现了IOP降低≥20%;在第42个月时，分别有61%、91%和91%的眼实现了IOP降低≥20%。多支架眼在第12个月和第42个月对额外药物的需求保持一致（两个时间点均为4只双支架眼和3只三支架眼），而单支架眼的需求增加（第12个月为4只眼，第42个月为18只眼）。所有组的安全性参数均有利。单个或多个iStent®器械的独立植入在术后42个月内产生了安全的、具有临床意义的IOP和药物降低，多支架眼的降低幅度逐渐增大且持续时间更长。
Evaluate long-term outcomes after one, two, or three trabecular micro-bypass stents implanted in a standalone procedure in eyes with open-angle glaucoma taking ocular hypotensive medication. Prospective randomized ongoing study of 119 subjects (109 with 42-month follow-up) with open-angle glaucoma, preoperative intraocular pressure (IOP) 18–30 mmHg on one to three glaucoma medications, and unmedicated (post-washout) IOP 22–38 mmHg. Subjects were randomized to receive one (n=38), two (n=41), or three (n=40) iStent trabecular micro-bypass stents in a standalone procedure. Postoperatively, IOP was measured with medication and annually following washout. Data included IOP, medications, gonioscopy, pachymetry, visual field, visual acuity, adverse events, and slit-lamp and fundus examinations. Preoperative mean medicated IOP was 19.8±1.3 mmHg on 1.71 medications in one-stent eyes, 20.1±1.6 mmHg on 1.76 medications in two-stent eyes, and 20.4±1.8 mmHg on 1.53 medications in three-stent eyes. Post-washout IOP prior to stent implantation was 25.0±1.2, 25.0±1.7, and 25.1±1.9 mmHg in the three groups, respectively. Postoperatively, Month 42 medicated IOP was 15.0±2.8, 15.7±1.0 and 14.8±1.3 mmHg in the three groups, and post-washout IOP (Months 36–37) was 17.4±0.9, 15.8±1.1 and 14.2±1.5 mmHg, respectively. IOP reduction ≥20% without medication was achieved in 89%, 90%, and 92% of one-, two-, and three-stent eyes, respectively, at Month 12; and in 61%, 91%, and 91% of eyes, respectively, at Month 42. The need for additional medication remained consistent at Months 12 and 42 in multi-stent eyes (four two-stent eyes and three three-stent eyes at both time points), whereas it increased in single-stent eyes (four eyes at Month 12 versus 18 eyes at Month 42). Safety parameters were favorable in all groups. The standalone implantation of either single or multiple iStent® device(s) produced safe, clinically meaningful IOP and medication reductions through 42 months postoperatively, with incrementally greater and more sustained reductions in multi-stent eyes.