New York University, New York, New York.
Wills Eye Hospital, Philadelphia, Pennsylvania.
Ophthalmology. 2024 Mar;131(3):266-276. doi: 10.1016/j.ophtha.2023.09.023. Epub 2023 Sep 27.
To compare the effectiveness and safety of the MicroShunt (Santen Inc) versus trabeculectomy in patients with primary open-angle glaucoma (POAG).
Prospective, randomized, multicenter trial conducted in the United States and Europe.
Adult patients (aged 40-85 years) with mild to severe POAG inadequately controlled on maximum tolerated medical therapy and intraocular pressure (IOP) ≥ 15 mmHg and ≤ 40 mmHg.
Patients were randomized 3:1 to stand-alone MicroShunt implantation (n = 395) or trabeculectomy (n = 132), both augmented with mitomycin C (MMC) 0.2 mg/ml for 2 minutes.
The primary effectiveness end point was surgical success, defined as ≥ 20% reduction in mean diurnal IOP from baseline with no increase in glaucoma medications. Secondary end points included changes in mean IOP and medication use from baseline and the need for postoperative interventions.
At 2 years, the rate of surgical success was lower in the MicroShunt group than in the trabeculectomy group (50.6% vs. 64.4%, P = 0.005). Mean diurnal IOP was reduced from 21.1 ± 4.9 mmHg at baseline to 13.9 ± 3.9 mmHg at 24 months in the MicroShunt group and from 21.1 ± 5.0 mmHg at baseline to 10.7 ± 3.7 mmHg at 24 months in the trabeculectomy group (P < 0.001 compared with baseline in both groups). Mean medication use decreased from 3.1 to 0.9 in the MicroShunt group and from 2.9 to 0.4 in the trabeculectomy group (P < 0.001 compared with baseline in both groups). Adverse events at 2 years were generally similar in the 2 groups, except that hypotony was more common in eyes undergoing trabeculectomy (51.1% vs. 30.9%, P < 0.001). Repositioning or explantation of the implant occurred in 6.8% of MicroShunt patients. The majority of these patients had device removal at the time of subsequent glaucoma surgery. Vision-threatening complications were uncommon in both groups.
At 2 years, both the MicroShunt and trabeculectomy provided significant reductions in IOP and medication use, with trabeculectomy continuing to have greater surgical success.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
比较 MicroShunt（Santen Inc）与小梁切除术治疗原发性开角型青光眼（POAG）患者的疗效和安全性。
前瞻性、随机、多中心试验，在美国和欧洲进行。
年龄在 40-85 岁之间的成年患者（轻度至重度 POAG 患者，最大耐受药物治疗后眼压（IOP）≥15mmHg 且≤40mmHg 控制不佳）。
患者随机分为 3:1 接受独立的 MicroShunt 植入（n=395）或小梁切除术（n=132），两者均用 0.2mg/ml 丝裂霉素 C（MMC）增强 2 分钟。
主要有效性终点为手术成功率，定义为平均日间 IOP 较基线下降≥20%，且抗青光眼药物无增加。次要终点包括从基线开始的平均 IOP 和药物使用变化以及术后干预的需要。
在 2 年时，MicroShunt 组的手术成功率低于小梁切除术组（50.6% vs. 64.4%，P=0.005）。MicroShunt 组的平均日间 IOP 从基线时的 21.1±4.9mmHg 降至 24 个月时的 13.9±3.9mmHg，小梁切除术组从基线时的 21.1±5.0mmHg 降至 24 个月时的 10.7±3.7mmHg（两组均与基线相比 P<0.001）。MicroShunt 组的平均用药量从 3.1 降至 0.9，小梁切除术组从 2.9 降至 0.4（两组均与基线相比 P<0.001）。两组 2 年时的不良事件一般相似，但小梁切除术组眼压过低更为常见（51.1% vs. 30.9%，P<0.001）。6.8%的 MicroShunt 患者需要重新定位或取出植入物。这些患者中的大多数在随后的青光眼手术时都去除了设备。两组视力威胁性并发症均不常见。
在 2 年时，MicroShunt 和小梁切除术均显著降低了 IOP 和药物使用量，小梁切除术的手术成功率更高。
本文末尾的脚注和披露中可能包含专有或商业披露信息。
