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XEN45真实世界评估:针对泡状隆起针刺及重大翻修结果的生存分析

XEN45 real-life evaluation: Survival analysis with bleb needling and major revision outcomes.

作者信息

Ventura-Abreu Néstor, Dotti-Boada Marina, Muniesa-Royo María Jesús, Izquierdo-Serra Jordi, González-Ventosa Andrea, Millá Elena, Pazos Marta

机构信息

Ophthalmology Department, Hospital Clínic de Barcelona, University of Barcelona (UB), Barcelona, Spain.

PhD Program, Instituto de Investigaciones Oftalmológicas Ramón Castroviejo, Department of Immunology, Ophthalmology and ORL, Faculty of Medicine, Complutense University of Madrid (UCM), Madrid, Spain.

出版信息

Eur J Ophthalmol. 2021 Apr 28:11206721211012847. doi: 10.1177/11206721211012847.

DOI:10.1177/11206721211012847
PMID:33908807
Abstract

PURPOSE

To evaluate real-life outcomes of XEN45 stent surgery including bleb needling (BN) and surgical bleb revision (SBR).

METHODS

Retrospective analysis of all XEN45 gel stents implanted in a tertiary glaucoma center with a minimum follow-up of 6 months. The main outcomes were intraocular pressure (IOP), the number of glaucoma medications, postoperative maneuvers like BN, and subsequent SBR. Success was defined as IOP ⩽ 18 and 20% reduction (criterion A), ⩽15 and 25% reduction (criterion B), and ⩽12 mmHg and 30% reduction (criterion C) reached with (qualified) or without (complete) medications at the last visit. Complete failure was defined as additional glaucoma surgery, loss of light perception, or sight-threatening complications. Multivariable Cox regression and Kaplan-Meier survival estimates tests were performed.

RESULTS

Fifty-eight eyes with either stand-alone or combined Phaco-XEN surgery were included. Complete success by the different definitions was 50.0% (95% confidence interval, 5.8%-84.5%) (A), 50.0% (5.8%-84.5%) (B), and 25% (0.9%-66.5%) (C) whereas qualified success was 38.3% (1.6%-80.1%), 31.7% (2.0%-71.4%), and 0%, respectively, at the 24-months visit. 30% of cases underwent BN with 5-Fluorouracil, and SBR was performed in 17.5% of eyes. Low IOP levels at 1-month and early BN were significantly associated with success. The highest chance of failure was achieved in the combined Phaco-XEN group undergoing SBR.

CONCLUSIONS

In our real-life setting, the first month IOP was associated with greater success rates. Although BN obtained improved IOP values, SBR was associated with a greater bleb survival in the stand-alone XEN group. Both BN and SBR had poor outcomes in the combined Phaco-XEN group.

摘要

目的

评估XEN45支架手术的实际效果,包括穿刺引流泡(BN)和手术性引流泡修复(SBR)。

方法

对一家三级青光眼中心植入的所有XEN45凝胶支架进行回顾性分析,随访时间至少为6个月。主要观察指标为眼压(IOP)、青光眼药物使用数量、术后操作如BN以及后续的SBR。成功定义为末次随访时使用(合格)或未使用(完全)药物情况下眼压≤18且降低20%(标准A)、≤15且降低25%(标准B)、≤12 mmHg且降低30%(标准C)。完全失败定义为再次进行青光眼手术、光感丧失或出现威胁视力的并发症。进行多变量Cox回归分析和Kaplan-Meier生存估计检验。

结果

纳入58只接受单纯或联合超声乳化-XEN手术的眼睛。按照不同定义,完全成功率分别为50.0%(95%置信区间,5.8%-84.5%)(标准A)、50.0%(5.8%-84.5%)(标准B)和25%(0.9%-66.5%)(标准C),而在24个月随访时,合格成功率分别为38.3%(1.6%-80.1%)、31.7%(2.0%-71.4%)和0%。30%的病例接受了5-氟尿嘧啶穿刺引流泡治疗,17.5%的眼睛进行了手术性引流泡修复。1个月时的低眼压水平和早期穿刺引流泡治疗与成功显著相关。在接受手术性引流泡修复的联合超声乳化-XEN组中失败几率最高。

结论

在我们的实际临床环境中,第一个月的眼压与更高的成功率相关。尽管穿刺引流泡治疗可改善眼压值,但在单纯XEN组中,手术性引流泡修复与引流泡的更长存活时间相关。在联合超声乳化-XEN组中,穿刺引流泡治疗和手术性引流泡修复的效果均较差。

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