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Preserflo 微分流管:疗效和内皮细胞密度。

Preserflo MicroShunt: Efficacy and Endothelial Cell Density.

机构信息

Department of Ophthalmology, University of Düsseldorf, Düsseldorf, Germany.

出版信息

J Glaucoma. 2023 Dec 1;32(12):1018-1021. doi: 10.1097/IJG.0000000000002325. Epub 2023 Oct 17.

Abstract

PRCIS

A main safety concern associated with new glaucoma implants is corneal endothelial cell loss, which could even be observed in already established procedures.

PURPOSE

The purpose of this study was to evaluate the efficacy and corneal safety, especially corneal endothelial cell loss (ECL), after Preserflo MicroShunt implantation.

METHODS

A monocentric, prospective clinical observational study of patients with a follow-up of at least 12 months who underwent Preserflo MicroShunt implantation at the Department of Ophthalmology, University Hospital of Düsseldorf, Germany, between January 2020 and October 2021. Endothelial cell density (ECD), the distance between the tip of the implant and the corneal endothelium, and the success of the surgery were analyzed.

RESULTS

In total, 14 eyes of 12 patients were included. After a mean follow-up of 20±2.7 months intraocular pressure was significantly reduced by 8.2 mm Hg (P=0.0041); in 28.6% of patients, a revision surgery was necessary. Reduction of preoperative and follow-up ECD was not statistically significant (ECL of 45 cells/mm2, ECDpreoperative=2074±703.6 cells/mm2, ECDlast follow-up=2029±742.3 cells/mm2, P=0.42). A longer intracameral shunt tube length correlated significantly with a higher distance between the shunt tip and corneal endothelium (r=0.61, P=0.036).

CONCLUSIONS

Preserflo MicroShunt effectively lowered intraocular pressure without substantial ECL after a minimum follow-up period of 17 months.

摘要

PRCIS

与新型青光眼植入物相关的一个主要安全问题是角膜内皮细胞丢失,即使在已确立的手术中也可能观察到。

目的

本研究旨在评估 Preserflo MicroShunt 植入后的疗效和角膜安全性,特别是角膜内皮细胞丢失(ECD)。

方法

这是一项在德国杜塞尔多夫大学医院眼科进行的单中心、前瞻性临床观察研究,纳入了 2020 年 1 月至 2021 年 10 月期间接受 Preserflo MicroShunt 植入并至少随访 12 个月的患者。分析了内皮细胞密度(ECD)、植入物尖端与角膜内皮之间的距离以及手术的成功率。

结果

共纳入 12 例患者的 14 只眼。平均随访 20±2.7 个月后,眼内压显著降低 8.2mmHg(P=0.0041);28.6%的患者需要进行修正手术。术前和随访时 ECD 的减少无统计学意义(ECD 丢失 45 个细胞/mm2,术前 ECD=2074±703.6 个细胞/mm2,末次随访 ECD=2029±742.3 个细胞/mm2,P=0.42)。更长的房内引流管长度与引流管尖端与角膜内皮之间的距离显著相关(r=0.61,P=0.036)。

结论

在至少 17 个月的随访期内,Preserflo MicroShunt 可有效降低眼内压,且 ECD 丢失不明显。

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