Garcia-Feijoo Julián, Batlle Juan F, Aptel Florent, Lachkar Yves, Riss Isabelle, Sadruddin Omar, Nguyen Tuan, Beckers Henny J M
Departamento de Oftalmologia, Universidad Complutense, Hospital Clínico San Carlos, OFTARED, IdISSC, Planta 3, Madrid, Spain.
Centro Láser, Santo Domingo, Dominican Republic.
Ophthalmol Ther. 2025 May 23. doi: 10.1007/s40123-025-01149-4.
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.
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).
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).
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.
PRESERFLO微型分流器是一种长度为8.5毫米（管腔直径70微米）的外控式过滤手术装置，由聚[苯乙烯-嵌段-异丁烯-嵌段-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）评估了微型分流器植入联合丝裂霉素C（MMC）的2年有效性和安全性。这项汇总分析比较了在微型分流器植入过程中接受0.2或0.4毫克/毫升MMC的患者的结局。
年龄在18至85岁之间、原发性开角型青光眼（眼压[IOP]为18至35毫米汞柱）在最大耐受药物治疗下无法控制和/或青光眼进展需要手术的患者，接受了微型分流器植入术，可伴有或不伴有白内障手术，并辅助使用0.2或0.4毫克/毫升MMC。两年的结局包括眼压和青光眼药物使用的变化、完全成功率（眼压≥6至＜14毫米汞柱或降低≥20%，无需使用药物）以及手术/装置相关不良事件（AE）和严重不良事件（SAE）的发生率。
在纳入的125例患者中，58例接受了0.2毫克/毫升MMC，67例接受了0.4毫克/毫升MMC。接受0.4毫克/毫升MMC的患者眼压平均降低百分比显著高于接受0.2毫克/毫升MMC的患者（-40.9%对-34.5%，P＜0.05）。在0.4毫克/毫升MMC组中，从基线到第2年，青光眼药物的平均使用量降至比0.2毫克/毫升MMC组更低的水平。在第2年，0.4毫克/毫升MMC组中无需使用药物的患者百分比（85.2%对58.0%，P＜0.01）和完全成功率（71.6%对48.3%，P＜0.01）显著高于0.2毫克/毫升MMC组。两组手术/装置相关AE和SAE的发生率无显著差异（P＞0.05）。
与接受0.2毫克/毫升MMC的患者相比，接受0.4毫克/毫升MMC的患者在第2年的眼压和青光眼药物使用量更低，完全成功率更高。尽管对于MMC的最佳浓度尚无共识，但这些发现可能会为外科医生提供指导，直至有来自对照试验的进一步证据。
