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PreserFlo微型分流器治疗日本剥脱性青光眼患者的短期疗效:倾向评分匹配法与原发性开角型青光眼的比较

Short-term outcomes of the PreserFlo MicroShunt in Japanese patients with exfoliation glaucoma: a comparison with primary open-angle glaucoma using propensity score matching.

作者信息

Yamae Teruki, Sakata Rei, Suzuki Haruyuki, Aoyama Yurika, Nemoto Hotaka, Saito Hitomi, Honjo Megumi, Shirato Shiroaki, Aihara Makoto

机构信息

Department of Ophthalmology, Graduate of Medicine and Faculty of Medicine, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.

Yotsuya Shirato Eye Clinic, Tokyo, Japan.

出版信息

Jpn J Ophthalmol. 2025 Aug 26. doi: 10.1007/s10384-025-01265-5.

DOI:10.1007/s10384-025-01265-5
PMID:40856918
Abstract

PURPOSE

This study evaluated the efficacy and safety of initially implanted PreserFlo MicroShunt (PMS) in Japanese patients with exfoliation glaucoma (XFG). Using propensity score matching, intraocular pressure (IOP) control rates were compared between patients with XFG and primary open-angle glaucoma (POAG).

STUDY DESIGN

Retrospective observational study.

METHODS

This study reviewed 31 eyes of 31 patients with XFG who underwent initial PMS implantation with mitomycin C. IOP, medication scores, and corneal endothelial cell density (CECD) were assessed preoperatively and at up to 6 months postoperatively. Kaplan-Meier analysis was used to estimate the 6-month survival rate, defined as an IOP reduction of > 20% from baseline and an IOP < 15 mmHg. The incidences of needling, reoperation, and complications were also assessed. IOP control was compared between XFG and propensity-score-matched POAG patients using the log-rank test.

RESULTS

At 6 months, the mean IOP had decreased significantly, from 22.3 ± 6.6 to 14.7 ± 6.6 mmHg, and the medication score had declined from 4.5 to 1.4. CECD decreased from 2127 to 1902 cells/mm, although this was not statistically significant. The complete success rate (without any glaucoma medications or intervention) was 48%. Postoperative complications included anterior chamber hemorrhage and choroidal detachment. Needling was performed in nine eyes (29.0%), and additional surgery was performed in five eyes (16.1%). Compared to POAG patients (11.9 mmHg), XFG patients had higher postoperative IOP (14.8 mmHg) and higher medication scores (0.5 vs 1.4, p = 0.04) and a lower success rate (62.2% vs 41.7%).

CONCLUSIONS

PMS in Japanese patients with XFG resulted in a significant IOP reduction over 6 months, with a relatively favorable safety profile. However, its efficacy was slightly inferior to that in POAG, implying potential differences in PMS responsiveness between glaucoma subtypes.

摘要

目的

本研究评估了初次植入PreserFlo微分流器(PMS)对日本剥脱性青光眼(XFG)患者的疗效和安全性。采用倾向评分匹配法,比较了XFG患者和原发性开角型青光眼(POAG)患者的眼压(IOP)控制率。

研究设计

回顾性观察研究。

方法

本研究回顾了31例接受初次PMS植入联合丝裂霉素C治疗的XFG患者的31只眼睛。在术前及术后6个月内评估眼压、药物评分和角膜内皮细胞密度(CECD)。采用Kaplan-Meier分析评估6个月生存率,定义为眼压较基线降低>20%且眼压<15 mmHg。还评估了针刺、再次手术和并发症的发生率。采用对数秩检验比较XFG患者和倾向评分匹配的POAG患者的眼压控制情况。

结果

6个月时,平均眼压显著降低,从22.3±6.6 mmHg降至14.7±6.6 mmHg,药物评分从4.5降至1.4。CECD从2127个细胞/mm降至1902个细胞/mm,尽管差异无统计学意义。完全成功率(无需任何青光眼药物或干预)为48%。术后并发症包括前房出血和脉络膜脱离。9只眼(29.0%)进行了针刺,5只眼(16.1%)进行了额外手术。与POAG患者(11.9 mmHg)相比,XFG患者术后眼压较高(14.8 mmHg),药物评分较高(0.5对1.4,p = 0.04),成功率较低(62.2%对41.7%)。

结论

日本XFG患者植入PMS后6个月眼压显著降低,安全性相对良好。然而,其疗效略逊于POAG患者,这意味着青光眼亚型之间PMS反应性可能存在差异。

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本文引用的文献

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Short-term efficacy and safety of PreserFlo MicroShunt in Japanese patients with medically treated primary open-angle glaucoma.PreserFlo微分流器在接受药物治疗的日本原发性开角型青光眼患者中的短期疗效和安全性。
Jpn J Ophthalmol. 2025 Mar;69(2):287-295. doi: 10.1007/s10384-024-01159-y. Epub 2025 Jan 18.
2
Transient hyphema associated with PRESERFLO MicroShunt surgery using a double-step knife in patients with glaucoma.青光眼患者行 PRESERFLO MicroShunt 手术采用双刀步切开时并发一过性前房积血。
Sci Rep. 2024 Nov 18;14(1):28457. doi: 10.1038/s41598-024-80093-y.
3
Postoperative Outcomes of PreserFlo MicroShunt in Patients with Exfoliation Glaucoma.
剥脱性青光眼患者使用PreserFlo微型分流器的术后结果
J Clin Med. 2024 Oct 15;13(20):6132. doi: 10.3390/jcm13206132.
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Ab-Externo MicroShunt versus Trabeculectomy in Primary Open-Angle Glaucoma: Two-Year Results from a Randomized, Multicenter Study.外引流微管植入术与小梁切除术治疗原发性开角型青光眼:一项随机、多中心研究的两年结果。
Ophthalmology. 2024 Mar;131(3):266-276. doi: 10.1016/j.ophtha.2023.09.023. Epub 2023 Sep 27.
5
Long-Term Outcomes of the PRESERFLO MicroShunt Implant in a Heterogeneous Glaucoma Cohort.PRESERFLO微分流植入术在异质性青光眼队列中的长期疗效
J Clin Med. 2023 Jul 4;12(13):4474. doi: 10.3390/jcm12134474.
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All Consecutive Ab Externo SIBS Microshunt Implantations With Mitomycin C: One-Year Outcomes and Risk Factors for Failure.所有连续的外路硅橡胶小梁切开术联合丝裂霉素C微分流植入术:一年的结果及失败的危险因素。
Am J Ophthalmol. 2023 Nov;255:125-140. doi: 10.1016/j.ajo.2023.06.009. Epub 2023 Jun 22.
7
Hypotony in the early postoperative period after MicroShunt implantation versus trabeculectomy: A registry study.微分流植入术与小梁切除术后早期低眼压的比较:一项注册研究
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