不同浓度丝裂霉素C治疗原发性开角型青光眼的三个微分流研究的综合分析。

IF 3.2 3区医学 Q2 OPHTHALMOLOGY

Ophthalmology and Therapy Pub Date : 2025-07-01 Epub Date: 2025-05-23 DOI:10.1007/s40123-025-01149-4

Julián Garcia-Feijoo, Juan F Batlle, Florent Aptel, Yves Lachkar, Isabelle Riss, Omar Sadruddin, Tuan Nguyen, Henny J M Beckers

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引用次数: 0

摘要

PRESERFLO MicroShunt是一款8.5 mm长（70 μ m流明）控制的体外过滤手术设备，由聚[苯乙烯块-异丁烯块-苯乙烯]（SIBS）制成。三项前瞻性、开放标签临床试验(ClinicalTrials.gov标识符：NCT00772330；NCT01563237;NCT02177123)评估MicroShunt植入联合丝裂霉素C (MMC) 2年的有效性和安全性。该汇总分析比较了MicroShunt植入期间接受0.2或0.4 mg/ml MMC的患者的结果。方法：年龄18-85岁的原发性开角型青光眼（眼压[IOP] 18-35 mmHg）患者，在最大耐受药物治疗下不受控制和/或青光眼进展需要手术的患者，接受MicroShunt植入伴/不伴白内障手术，辅助使用0.2或0.4 mg/ml MMC。两年的结果包括IOP和青光眼药物的变化，完全成功率（IOP≥6）。结果：在125例纳入的患者中，58例接受0.2 mg/ml MMC治疗，67例接受0.4 mg/ml MMC治疗。接受0.4 mg/ml MMC治疗的患者IOP平均降低率显著高于0.2 mg/ml MMC治疗的患者（- 40.9% vs - 34.5%, P 0.05）。结论：与0.2 mg/ml MMC相比，服用0.4 mg/ml MMC的患者在第2年的IOP和青光眼药物使用率更低，完全成功率更高。尽管对MMC的最佳浓度没有共识，但这些发现可以指导外科医生，直到从对照试验中获得进一步的证据。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Pooled Analysis of Three MicroShunt Studies in Primary Open-Angle Glaucoma Evaluating Different Concentrations of Applied Mitomycin C.

Introduction: The PRESERFLO MicroShunt is an 8.5-mm-long (70-µm lumen) controlled ab externo filtration surgery device made from poly[styrene-block-isobutylene-block-styrene] (SIBS). Three prospective, open-label clinical trials (ClinicalTrials.gov Identifiers: NCT00772330; NCT01563237; NCT02177123) evaluated the 2-year effectiveness and safety of MicroShunt implantation plus mitomycin C (MMC). This pooled analysis compared outcomes in patients receiving 0.2 or 0.4 mg/ml MMC during MicroShunt implantation.

Methods: Patients aged 18-85 years with primary open-angle glaucoma (intraocular pressure [IOP] 18-35 mmHg) uncontrolled on maximal tolerated medical therapy and/or where glaucoma progression warranted surgery who underwent MicroShunt implantation with/without cataract surgery, and with adjunctive use of 0.2 or 0.4 mg/ml MMC. Two-year outcomes included changes in IOP and glaucoma medications, complete success rates (IOP ≥ 6 to < 14 mmHg or ≥ 20% reduction, without medications), and rates of procedure/device-related adverse events (AEs) and serious AEs (SAEs).

Results: Of the 125 included patients, 58 received 0.2 mg/ml MMC and 67 received 0.4 mg/ml MMC). Mean percent reduction in IOP was significantly greater in patients receiving 0.4 than 0.2 mg/ml MMC (- 40.9% vs. - 34.5%, P < 0.05). Mean glaucoma medication use was reduced to a lower level between baseline and year 2 in the 0.4 than in the 0.2 mg/ml MMC group. At year 2, the percentage of medication-free patients (85.2% vs. 58.0%, P < 0.01) and the complete success rates (71.6% vs. 48.3%, P < 0.01) were significantly higher in the 0.4 than in the 0.2 mg/ml MMC group. Rates of procedure/device-related AEs and SAEs did not differ significantly in the two groups (P > 0.05).

Conclusions: IOP and glaucoma medication use at year 2 were lower, and complete success rate was higher, in patients administered 0.4 mg/ml than 0.2 mg/ml MMC. Although there is no consensus on the optimal concentration of MMC, these findings may guide surgeons until further evidence from controlled trials becomes available.

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来源期刊

Ophthalmology and Therapy OPHTHALMOLOGY-

CiteScore

4.20

自引率

3.00%

发文量

157

审稿时长

6 weeks

期刊介绍： Aims and Scope Ophthalmology and Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from preclinical, clinical (all phases), observational, real-world, and health outcomes research around the use of ophthalmological therapies, devices, and surgical techniques. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Ophthalmology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. 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