University Eye Clinic, Maastricht University Medical Center, Maastricht, the Netherlands.
CHU de Grenoble-Alpes, Grenoble, France.
Ophthalmol Glaucoma. 2022 Mar-Apr;5(2):195-209. doi: 10.1016/j.ogla.2021.07.008. Epub 2021 Jul 28.
To assess the safety and effectiveness of the PRESERFLO® MicroShunt (formerly InnFocus MicroShunt) in patients with primary open-angle glaucoma (POAG).
The MicroShunt, a controlled ab externo glaucoma filtration surgery device, was investigated in a 2-year, multicenter, single-arm study.
Eligible patients were aged 18-85 years with POAG inadequately controlled on maximal tolerated medical therapy with intraocular pressure (IOP) ≥18 and ≤35 mmHg or when glaucoma progression warranted surgery.
The MicroShunt was implanted as a stand-alone procedure with adjunctive use of topical mitomycin C (MMC; 0.2-0.4 mg/ml) for 2-3 minutes.
The primary effectiveness outcome was IOP reduction and success (not requiring reoperation or pressure failures [IOP > 21 mmHg and < 20% reduction in IOP]) at year 1. Additional end points at year 2 included IOP reduction, success, glaucoma medications, adverse events (AEs), and reoperations. Results are reported in the overall population and subgroups of patients receiving 0.2 or 0.4 mg/ml MMC.
In 81 patients, mean (± standard deviation [SD]) IOP decreased from 21.7 ± 3.4 mmHg at baseline to 14.5 ± 4.6 mmHg at year 1 and 14.1 ± 3.2 mmHg at year 2 (P < 0.0001). Overall success (with and without supplemental glaucoma medication use) at year 1 was 74.1%. Mean (± SD) number of medications decreased from 2.1 ± 1.3 at baseline to 0.5 ± 0.9 at year 2 (P < 0.0001), and 73.8% of patients were medication free. Most common nonserious AEs were increased IOP requiring medication or selective laser trabeculoplasty (25.9%) and mild-to-moderate keratitis (11.1%). There were 6 (7.4%) reoperations and 5 (6.2%) needlings by year 2. In an analysis (post hoc) according to MMC concentration, overall success was 78.1% (0.2 mg/ml) and 74.4% (0.4 mg/ml; P = 0.710). In the 0.2 and 0.4 mg/ml MMC groups, 51.9% and 90.3% of patients were medication free, respectively (P = 0.001). There was a trend toward lower IOP and higher medication reduction in the 0.4 mg/ml MMC subgroup.
In this study, mean IOP and glaucoma medication reductions were significant and sustained over 2 years postsurgery. No long-term, sight-threatening AEs were reported. Further studies may confirm potential risk/benefits of higher MMC concentration.
评估 PRESERFLO® MicroShunt（前身为 InnFocus MicroShunt）在原发性开角型青光眼（POAG）患者中的安全性和有效性。
MicroShunt 是一种经控制的外眼滤过性手术设备，在一项为期 2 年、多中心、单臂研究中进行了研究。
符合条件的患者年龄在 18-85 岁之间，在接受最大耐受的药物治疗后，眼压（IOP）≥18mmHg 且≤35mmHg 时，POAG 控制不佳，或者当青光眼进展需要手术时。
MicroShunt 作为一种独立的手术程序进行植入，并辅助使用局部丝裂霉素 C（MMC；0.2-0.4mg/ml）持续 2-3 分钟。
主要有效性终点为第 1 年的 IOP 降低和成功率（不需要再次手术或眼压失败[IOP＞21mmHg 且 IOP 降低＜20%]）。第 2 年的其他终点包括 IOP 降低、成功率、青光眼药物、不良事件（AE）和再次手术。结果以总体人群和接受 0.2 或 0.4mg/ml MMC 的患者亚组报告。
在 81 名患者中，平均（±标准差[SD]）IOP 从基线时的 21.7±3.4mmHg 降至第 1 年的 14.5±4.6mmHg 和第 2 年的 14.1±3.2mmHg（P＜0.0001）。第 1 年的总体成功率（包括和不包括补充青光眼药物使用）为 74.1%。平均（±SD）药物数量从基线时的 2.1±1.3 降至第 2 年时的 0.5±0.9（P＜0.0001），73.8%的患者无需药物治疗。最常见的非严重 AE 是需要药物治疗或选择性激光小梁成形术的眼压升高（25.9%）和轻度至中度角膜炎（11.1%）。第 2 年有 6 例（7.4%）再次手术和 5 例（6.2%）需要针刺。根据 MMC 浓度进行的分析（事后分析）显示，总体成功率为 78.1%（0.2mg/ml）和 74.4%（0.4mg/ml；P=0.710）。在 0.2 和 0.4mg/ml MMC 组中，分别有 51.9%和 90.3%的患者无需药物治疗（P=0.001）。0.4mg/ml MMC 亚组的 IOP 降低和药物减少趋势更为明显。
在这项研究中，术后 2 年，平均 IOP 和青光眼药物的降低是显著且持续的。未报告长期、威胁视力的 AE。进一步的研究可能证实更高 MMC 浓度的潜在风险/获益。
