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Preserflo微型分流器与小梁切除术的临床结果:一项为期6个月的回顾性研究。

Clinical Outcomes of Preserflo MicroShunt versus Trabeculectomy: A Retrospective 6-Month Study.

作者信息

Majtánová Nora, Takáčová Adriana, Herdová Lucia, Kurilová Veronika, Majtán Juraj, Fellner Zlatica, Cholevík Dalibor, Kolář Petr

出版信息

Cesk Slov Oftalmol. 2025;81(Ahead of Print):1-11. doi: 10.31348/2025/35.

DOI:10.31348/2025/35
PMID:40843645
Abstract

OBJECTIVE

To characterize and compare the efficacy and safety of trabeculectomy and Preserflo microshunt (PMS) implantation in patients with openangle glaucoma.

MATERIAL AND METHODS

This retrospective 6-month study included 100 eyes (100 patients). The 100 patients were divided into two groups of 50 patients, who were randomly assigned to either trabeculectomy or PMS implantation with mmC (0.4 mg/ml) applied using saturated sponges. The patients attended follow-up checks at 1, 8, 30, and 90 days postoperatively and at 6 months postoperatively. Endothelial cells were assessed at 3 and 6 months respectively. The main observed parameters were intraocular pressure (IOP), best corrected visual acuity (BCVA), anterior chamber depth (ACD), corneal hysteresis (CH), corneal endothelial cell density (CECD), coefficient of variation (CV), and antiglaucoma treatment.

RESULTS

In patients after trabeculectomy and after PMS implantation a comparable reduction in mean IOP values of 40.2% and 45.8% respectively was recorded for both surgical approaches in comparison with the preoperative mean IOP values. In all the studied patients, regardless of the type of surgical procedure, a significant reduction of CECD values was recorded 6 months after surgery. However, PMS implantation led to a greater reduction in antiglaucoma treatment postoperatively compared to trabeculectomy. Qualified success was almost identical in the case of both operations throughout the entire course, complete success was higher in favor of PMS at the beginning of the observation, but their values converged or met from approximately day 90 to month 6.

CONCLUSION

The performed clinical evaluation of the efficacy and safety of PMS implantation compared to the classical surgical approach using trabeculectomy showed positive results related primarily to the reduction of postoperative complications, while maintaining the effectiveness of the surgical procedure. However, further clinical studies with a longer follow-up period are needed in order to provide long-term evidence of clinical efficacy.

摘要

目的

对小梁切除术和Preserflo微分流器(PMS)植入术治疗开角型青光眼患者的疗效和安全性进行特征描述及比较。

材料与方法

这项为期6个月的回顾性研究纳入了100只眼(100例患者)。100例患者被分为两组,每组50例,随机分配接受小梁切除术或使用饱和海绵应用丝裂霉素C(0.4mg/ml)的PMS植入术。患者在术后1天、8天、30天、90天及6个月时进行随访检查。分别在3个月和6个月时评估内皮细胞。主要观察参数包括眼压(IOP)、最佳矫正视力(BCVA)、前房深度(ACD)、角膜滞后(CH)、角膜内皮细胞密度(CECD)、变异系数(CV)及抗青光眼治疗情况。

结果

与术前平均眼压值相比,小梁切除术后和PMS植入术后患者的平均眼压值分别降低了40.2%和45.8%,两种手术方法降低幅度相当。在所有研究患者中,无论手术方式如何,术后6个月时CECD值均显著降低。然而,与小梁切除术相比,PMS植入术后抗青光眼治疗的减少幅度更大。在整个过程中,两种手术的合格成功率几乎相同,在观察开始时,完全成功率PMS更高,但从大约第90天到第6个月时,二者数值趋于一致或相等。

结论

与使用小梁切除术的传统手术方法相比,对PMS植入术的疗效和安全性进行的临床评估显示出积极结果,主要与术后并发症的减少有关,同时保持了手术的有效性。然而,需要进行更长随访期的进一步临床研究,以提供临床疗效的长期证据。

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