Précis: 

Intermediate-term results suggest that ab interno Minimally Invasive Micro Sclerostomy (MIMS) stent-less subconjunctival filtration procedure is a promising treatment option for patients with open-angle glaucoma (OAG).

Purpose: 

MIMS is a novel ab interno, stent-less, subconjunctival filtration procedure. This study set to investigate the safety, performance, and efficacy of MIMS in OAG patients.

Methods: 

Prospective, open-label, single arm clinical trial with intrasubject comparisons. Study participants were adults with OAG who were candidates for a filtration procedure. Patients were operated by a single surgeon (A.A.) in Chennai, India. Following mitomycin-C pretreatment, ab interno MIMS procedure was performed alone or combined with phacoemulsification surgery. Procedure-related complications and adverse events were assessed. Primary outcomes: patients (%) achieving an intraocular pressure (IOP) ≥5 mm Hg and ≤18 mm Hg, and an IOP reduction of >20% as compared with baseline, with or without hypotensive medications, with no need for recurrent surgery.

Results: 

Twenty-one phacoemulsification-MIMS and 10 standalone MIMS procedures were performed. Mean age was 63.94±6.33 years. Mean duration of MIMS was 1:58±0:25 (min:s). Scleral tunnels were achieved in all cases. No device malfunctions, intraoperative complications, or serious adverse events were reported. Five (16.12%) patients presented with iris clogging 1 to 24 weeks following procedure. Two were treated with laser and 3 required trabeculectomy. Mean IOP change from baseline at 24 weeks was 47.4% (31.2 to 16.4 mm Hg, P<0.0001, n=23). The mean difference was −14.8 mm Hg (95% confidence interval: −17.6, −11.9) with no statistically significant differences between groups. Qualified success was achieved in 21 (84%), 17 (74%), and 13 (93%) after 12, 24, and 52 weeks, respectively. Complete success was achieved in 17 (68%), 13 (57%), and 8 (57%) after 12, 24, and 52 weeks, respectively.

Conclusions: 

The interim results suggest that MIMS procedure may be a simple and effective surgical option for early OAG patients requiring target IOP in high teens although iris clogging of incision site is the major concern with this procedure.

中文翻译：

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微创显微巩膜造口术 (MIMS) 手术：一种新型青光眼滤过手术

概要： 

中期结果表明，体内微创微创巩膜造口术（MIMS）无支架结膜下滤过手术对于开角型青光眼（OAG）患者来说是一种有前景的治疗选择。

目的： 

MIMS 是一种新型的体内、无支架、结膜下滤过手术。本研究旨在调查 MIMS 在 OAG 患者中的安全性、性能和有效性。

方法： 

具有受试者内比较的前瞻性、开放标签、单臂临床试验。研究参与者是患有 OAG 的成年人，他们是过滤程序的候选者。患者由印度钦奈的一名外科医生 (AA) 进行手术。丝裂霉素-C 预处理后，单独进行内部 MIMS 手术或与超声乳化手术联合进行。评估了手术相关的并发症和不良事件。主要结局：患者 (%) 达到眼压(IOP) ≥5 mm Hg 和 ≤18 mm Hg，并且与基线相比，IOP 降低 >20%，无论是否使用降压药物，无需再次手术。

结果： 

进行了 21 例超声乳化-MIMS 手术和 10 例独立 MIMS 手术。平均年龄为 63.94±6.33 岁。MIMS 的平均持续时间为 1:58±0:25（分钟：秒）。所有病例均实现了巩膜隧道。没有报告设备故障、术中并发症或严重不良事件。5 名 (16.12%) 患者在术后 1 至 24 周内出现虹膜堵塞。其中 2 例接受了激光治疗，3 例需要进行小梁切除术。24 周时眼压相对于基线的平均变化为 47.4%（31.2 至 16.4 mm Hg ，P <0.0001，n=23）。平均差异为-14.8 mm Hg（95%置信区间：-17.6，-11.9），组间无统计学显着差异。在 12 周、24 周和 52 周后，分别有 21 例 (84%)、17 例 (74%) 和 13 例 (93%) 获得了合格的成功。在 12 周、24 周和 52 周后分别有 17 例 (68%)、13 例 (57%) 和 8 例 (57%) 获得完全成功。

结论： 

中期结果表明，对于需要在十几岁左右达到目标眼压的早期 OAG 患者来说，MIMS 手术可能是一种简单而有效的手术选择，尽管切口部位的虹膜堵塞是该手术的主要问题。