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XEN45凝胶支架内植入与外植入的临床结果

Clinical Outcomes of Ab Interno Placement versus Ab Externo Placement of XEN45 Gel Stents.

作者信息

Ruda Rachel C, Yuan Lucy, Lai Gregory M, Raiciulescu Sorana, Kim Won I

机构信息

Walter Reed National Military Medical Center, Bethesda, Maryland.

Department of Ophthalmology, Madigan Army Medical Center, Tacoma, Washington.

出版信息

Ophthalmol Glaucoma. 2023 Jan-Feb;6(1):4-10. doi: 10.1016/j.ogla.2022.07.002. Epub 2022 Jul 15.

Abstract

PURPOSE

To compare the effectiveness of ab interno versus ab externo placement of XEN45 gel stents in patients with open-angle glaucoma.

DESIGN

Single-center, noncontrolled, retrospective, comparative case series.

PARTICIPANTS

Eighty-nine eyes of 89 patients with open-angle glaucoma who underwent XEN45 gel stent implantation.

METHODS

Patients underwent either ab interno (group 1) or ab externo (group 2) placement of a XEN45 stent between 2017 and 2020 by a single surgeon. Outcomes were recorded at each follow-up visit from postoperative day 1 up to 24 months, with median follow-up lengths of 12 months and 8 months for groups 1 and 2, respectively.

MAIN OUTCOME MEASURES

The primary outcome measure was the surgical success rate at 8 months. Secondary measures were postoperative intraocular pressure (IOP) and medication usage, complication rates, and bleb revision rates.

RESULTS

Success rates at 8 months were 72% in group 1 (n = 29) and 74% in group 2 (n = 60). There was no difference in the median time to failure between groups (P = 0.98). The mean baseline IOPs were 22.8 ± 7.5 on 3.8 ± 0.9 medications in group 1 and 25.3 ± 10.7 on 3.7 ± 1 medications in group 2. At the last follow-up among eyes with surgical success, the mean IOPs were 12.5 ± 3.8 on 2.2 ± 1.4 medications in group 1 and 12.2 ± 2.1 on 1.8 ± 1.3 medications in group 2. The adjusted mean IOPs and numbers of medications used were significantly lower after XEN45 stent implantation at all postoperative time points compared with baseline in both groups (P < 0.05). There were no significant differences in postoperative adjusted mean IOPs or medications used between the groups at any of the follow-up time points. Complication rates and bleb revision rates were comparable between both groups (P > 0.05).

CONCLUSIONS

The ab externo approach of XEN45 stent placement demonstrates comparable effectiveness to the ab interno approach in patients with open-angle glaucoma, although this study was underpowered to detect a difference in success rates between groups.

摘要

目的

比较XEN45凝胶支架经内路与经外路植入治疗开角型青光眼患者的有效性。

设计

单中心、非对照、回顾性、比较病例系列研究。

研究对象

89例接受XEN45凝胶支架植入术的开角型青光眼患者的89只眼。

方法

2017年至2020年期间,由一名外科医生对患者进行XEN45支架经内路(第1组)或经外路(第2组)植入。从术后第1天至24个月的每次随访中记录结果,第1组和第2组的中位随访时间分别为12个月和8个月。

主要观察指标

主要观察指标为8个月时的手术成功率。次要指标为术后眼压(IOP)和药物使用情况、并发症发生率及滤过泡修复率。

结果

第1组(n = 29)8个月时的成功率为72%,第2组(n = 60)为74%。两组间失败的中位时间无差异(P = 0.98)。第1组平均基线眼压为22.8±7.5,使用3.8±0.9种药物;第2组平均基线眼压为25.3±10.7,使用3.7±1种药物。在手术成功的眼中,末次随访时,第1组平均眼压为12.5±3.8,使用2.2±1.4种药物;第2组平均眼压为12.2±2.1,使用1.8±1.3种药物。与基线相比,两组在所有术后时间点XEN45支架植入后的调整后平均眼压和使用的药物数量均显著降低(P < 0.05)。在任何随访时间点,两组间术后调整后平均眼压或使用的药物均无显著差异。两组并发症发生率和滤过泡修复率相当(P > 0.05)。

结论

XEN45支架经外路植入方法在开角型青光眼患者中显示出与经内路植入方法相当的有效性,尽管本研究检测两组成功率差异的效能不足。

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