Supplementary Material for: A 2-Year, Single-Center Study to Assess the Safety and Effectiveness of the MicroShunt in Primary Open Angle Glaucoma

Aim: To assess the effectiveness and safety of the MicroShunt (formerly known as the MIDI-Arrow or InnFocus MicroShunt®), an 8.5-mm-long, 70-µm lumen controlled ab-externo glaucoma filtration surgery device made from poly(styrene-block-isobutylene-block-styrene) (SIBS), in patients with primary open-angle glaucoma (POAG). Methods: A 2-year, single-center, single-surgeon, non-randomized, adaptive feasibility clinical study (NCT01563237) was conducted in France from June 2011 to November 2016. Eligible patients were aged 18–85 years and had POAG inadequately controlled on maximum tolerated medical therapy with intraocular pressure (IOP) ≥18 and ≤40 mmHg. The MicroShunt was implanted ab externo with adjunctive use of Mitomycin C (0.2–0.4 mg/mL applied for 2–3 minutes), alone or in combination with cataract surgery. The primary effectiveness endpoints were the reduction in IOP relative to the preoperative value assessed at each postoperative visit and the measurement of success at years 1 and 2. The primary safety endpoint was the incidence of all procedure- and/or device-related adverse events (AEs) during the study. The secondary effectiveness endpoint was the mean number of glaucoma medications per patient, and the secondary safety endpoint was the incidence of glaucoma reoperation. Results: Sixty-one eyes from 61 patients underwent MicroShunt implantation. Mean IOP ± standard deviation (SD) was significantly reduced from 25.7 ± 6.1 mmHg at baseline (N = 61) to 15.8 ± 4.7 mmHg at year 1 (n = 58) and 16.5 ± 6.0 mmHg at year 2 (n = 52) (both p < 0.001). Overall success rates for patients achieving IOP ≥6 mmHg and <21 mmHg at year 1 and year 2 were 80.3% and 75.4%, respectively. Mean ± SD number of glaucoma medications per patient decreased significantly from 2.9 ± 1.1 at baseline to 0.6 ± 1.0 at year 1 (n = 58) and 1.0 ± 1.3 at year 2 (n = 52) (both p < 0.001). The most common procedure- and/or device-related AEs were investigator-reported increased IOP and hyphema. Four patients required reoperation. Conclusions: In this study, sustained reductions in mean IOP and number of glaucoma medications from baseline were observed up to 2 years post surgery. No long-term, sight-threatening AEs were observed.

研究目标：评估MicroShunt（原称MIDI-Arrow或InnFocus MicroShunt®）的有效性与安全性。该器械为长8.5 mm、管腔直径70 μm的控制性外路青光眼滤过手术装置，由聚(苯乙烯-异丁烯-苯乙烯)（SIBS）制成，适用于原发性开角型青光眼（primary open-angle glaucoma, POAG）患者。
研究方法：本研究为一项为期2年的单中心、单术者、非随机适应性可行性临床研究（临床试验编号NCT01563237），于2011年6月至2016年11月在法国开展。入组患者年龄为18~85岁，且在接受最大耐受剂量药物治疗后仍未得到有效控制的原发性开角型青光眼患者，其眼压（intraocular pressure, IOP）≥18 mmHg且≤40 mmHg。手术采用外路途径植入MicroShunt，联合使用丝裂霉素C（0.2~0.4 mg/mL，浸润2~3分钟），术式可单独施行或联合白内障手术。主要有效性终点为各术后随访时点相较于基线的眼压降幅，以及术后1年、2年的手术成功率；主要安全性终点为研究期间所有手术及/或器械相关不良事件（adverse events, AEs）的发生率。次要有效性终点为每位患者的青光眼药物平均使用数量，次要安全性终点为青光眼再次手术的发生率。
研究结果：共61例患者的61只眼接受了MicroShunt植入术。基线时平均眼压±标准差（standard deviation, SD）为25.7±6.1 mmHg（N=61），术后1年降至15.8±4.7 mmHg（n=58，p<0.001），术后2年降至16.5±6.0 mmHg（n=52，p<0.001），两组比较差异均具有统计学显著性。术后1年、2年达到眼压≥6 mmHg且<21 mmHg的患者总体成功率分别为80.3%和75.4%。每位患者的青光眼药物平均使用数量从基线时的2.9±1.1显著降至术后1年的0.6±1.0（n=58，p<0.001）及术后2年的1.0±1.3（n=52，p<0.001）。最常见的手术及/或器械相关不良事件为研究者报告的眼压升高与前房积血。共有4例患者需要接受再次手术。
研究结论：本研究结果显示，术后随访长达2年时，患者的平均眼压与青光眼药物使用数量较基线均实现持续降低，未观察到长期的、威胁视力的不良事件。