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单独植入PreserFlo微分流器的3年真实世界结果——有效性和安全性概况。

3-year real-world outcomes of standalone PreserFlo MicroShunt implantation - effectiveness and safety profile.

作者信息

Skowronski Adrian, Habbe Kirsten Julia, Kontopoulou Kalliopi, Kohlhaas Markus, Fili Sofia

机构信息

Department of Ophthalmology, St. Johannes Hospital Dortmund, Johannesstrasse 9-17, 44137, Dortmund, Germany.

出版信息

Graefes Arch Clin Exp Ophthalmol. 2025 Jul 31. doi: 10.1007/s00417-025-06928-0.

Abstract

PURPOSE

To report the three-year clinical outcomes and safety profile of standalone PreserFlo MicroShunt implantation.

METHODS

A single-center, retrospective study of 151 eyes from 109 patients with open-angle glaucoma who underwent standalone microshunt implantation between February 2019 and December 2020.

RESULTS

The mean IOP decreased significantly from 22.64 ± 8.79mmHg preoperatively to 12.76 ± 3.93mmHg three years postoperatively, with a mean IOP reduction of 43.6% (p = < 0.001). The need for IOP-lowering medication was significantly reduced from 2.64 ± 1.15 at baseline to 0.71 ± 1.12 after three years, representing a mean reduction of 73.1% (p = < 0.001). Three years post-implantation, 64.41% of eyes were free of glaucoma medication. Qualified and complete surgical success (IOP ≤ 21mmHg) was achieved in 77.6% and 42.3% of eyes, respectively, at three years. The most common complications were transient ocular hypotony (40.4%), choroidal detachment (13.25%), hyphema (11.92%). The vast majority of complications were self-limiting and did not pose a threat to vision. Open revision surgery was necessary in 14 eyes (9.27%). 7 eyes (4.63%) underwent further glaucoma surgery due to surgical failure. No statistically significant reduction in endothelial cell density (ECD) was observed 3 years after microshunt implantation (n = 13; p = 0.526).

CONCLUSION

PreserFlo MicroShunt implantation is an effective surgical technique for lowering intraocular pressure and reducing the need for antiglaucoma medication while maintaining a favorable safety profile. Its effect remains stable three years after surgery.

摘要

目的

报告单独植入PreserFlo微型分流器的三年临床疗效和安全性。

方法

一项单中心回顾性研究,纳入了2019年2月至2020年12月期间109例开角型青光眼患者的151只眼,这些患者接受了单独的微型分流器植入术。

结果

平均眼压从术前的22.64±8.79mmHg显著降至术后三年的12.76±3.93mmHg,平均眼压降低了43.6%(p<0.001)。降低眼压药物的使用需求从基线时的2.64±1.15显著降至三年后的0.71±1.12,平均降低了73.1%(p<0.001)。植入三年后,64.41%的眼睛无需使用青光眼药物。三年时,分别有77.6%和42.3%的眼睛达到了合格且完全的手术成功(眼压≤21mmHg)。最常见的并发症是短暂性低眼压(40.4%)、脉络膜脱离(13.25%)、前房积血(11.92%)。绝大多数并发症是自限性的,对视力无威胁。14只眼(9.27%)需要进行开放性翻修手术。7只眼(4.63%)因手术失败接受了进一步的青光眼手术。微型分流器植入三年后,未观察到内皮细胞密度(ECD)有统计学意义的降低(n = 13;p = 0.526)。

结论

PreserFlo微型分流器植入术是一种有效的手术技术,可降低眼压并减少抗青光眼药物的使用需求,同时保持良好的安全性。术后三年其效果仍稳定。

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