Eye Physicians and Surgeons of Arizona, Scottsdale, Arizona, USA.
Fry Eye Associates, Fort Worth, Texas, USA.
Am J Ophthalmol. 2019 Dec;208:219-225. doi: 10.1016/j.ajo.2019.07.015. Epub 2019 Aug 1.
To characterize the long-term (up to 5 years) safety and effectiveness of the supraciliary Micro-Stent (Alcon) implanted at the time of phacoemulsification in eyes with coexisting open-angle glaucoma (OAG) and visually significant cataract.
Three-year safety extension of a 2-year randomized clinical trial.
Patients from the multicenter Study of an Implantable Device for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery (COMPASS) trial who underwent Micro-Stent implantation plus phacoemulsification (n = 215) or phacoemulsification alone (n = 67) were evaluated 36, 48, and 60 months postoperatively. The primary outcome measurement was the occurrence of sight-threatening ocular adverse events. Evaluations at each time point included best-corrected visual acuity (BCVA), anterior and posterior segment examinations, tonometry, gonioscopy, pachymetry, perimetry, specular microscopy, and assessment of adverse events.
Three sight-threatening ocular adverse events occurred, 2 in the Micro-Stent group and 1 in the control group, but none of these events was related to the Micro-Stent device. Ocular adverse events were of similar frequencies in both groups, the most common of which were BCVA loss of ≥2 lines compared with best BCVA in COMPASS and worsening of visual field mean defect (VFMD) ≥2.5 dB compared with month 24. Changes in mean BCVA from baseline, clinical examinations, pachymetry, and VFMD were similar in the 2 groups. At 60 months, a higher proportion of subjects in the Micro-Stent group (46%; 95% confidence interval [CI], 38.9%-53.2%) than in the control group (32.1%; 95% CI 19.9%-46.3%) were able to achieve a reduction of ≥20% in intraocular pressure without using hypotensive medication.
Few sight-threatening serious ocular adverse events occurred following Micro-Stent implantation, and clinical evidence of corneal decompensation was minimal.
描述在超声乳化白内障吸除术中同时植入巩膜下微支架（爱尔康）治疗合并开角型青光眼（OAG）和明显白内障的患者的长期（最长 5 年）安全性和有效性。
一项为期 2 年的随机临床试验的 3 年安全性扩展研究。
对接受微支架植入联合超声乳化白内障吸除术（n=215）或单纯超声乳化白内障吸除术（n=67）的多中心研究中植入装置降低青光眼患者白内障术后眼内压（COMPASS）试验患者进行 36、48 和 60 个月的术后评估。主要观察指标是发生威胁视力的眼部不良事件。每次评估时均进行最佳矫正视力（BCVA）、眼前节和后节检查、眼压测量、房角镜检查、角膜厚度测量、视野检查、共焦显微镜检查和不良事件评估。
3 例发生威胁视力的眼部不良事件，2 例发生在微支架组，1 例发生在对照组，但均与微支架装置无关。两组眼部不良事件的发生率相似，最常见的是与 COMPASS 中最佳 BCVA 相比 BCVA 下降≥2 行和与第 24 个月相比视野平均缺损（VFMD）恶化≥2.5dB。两组间从基线到平均 BCVA、临床检查、角膜厚度和 VFMD 的变化相似。60 个月时，微支架组（46%；95%置信区间 [CI]，38.9%-53.2%）比对照组（32.1%；95% CI，19.9%-46.3%）中有更多的患者能够在不使用降压药物的情况下将眼压降低≥20%。
微支架植入后发生的威胁视力的严重眼部不良事件较少，角膜失代偿的临床证据很少。
