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伴有超声乳化白内障吸除术的房角开放型青光眼 Schlemm 管微支架(Hydrus 微支架)三年的疗效。

Three-Year Outcomes of a Schlemm Canal Microstent (Hydrus Microstent) with Concomitant Phacoemulsification in Open-Angle Glaucoma.

机构信息

Department of Ophthalmology, Faculty of Medicine, McGill University, Montreal, Quebec, Canada; Montreal Glaucoma Institute and Bellevue Ophthalmology Clinics, Montreal, Quebec, Canada.

Montreal Glaucoma Institute and Bellevue Ophthalmology Clinics, Montreal, Quebec, Canada; Department of Ophthalmology, University of Montreal, Montreal, Quebec, Canada; Department of Ophthalmology, Kaplan Medical Center, Rehovot and the Hebrew University of Jerusalem-Hadassah Medical School, Jerusalem, Israel.

出版信息

Ophthalmol Glaucoma. 2023 Mar-Apr;6(2):137-146. doi: 10.1016/j.ogla.2022.08.012. Epub 2022 Aug 28.

Abstract

PURPOSE

HORIZON trials have reported the medium- and long-term outcomes of the Hydrus microstent. However, outside of randomized clinical trials, outcomes beyond 24 months have not been previously reported. Here, we examine the 3-year outcomes of the Hydrus microstent with cataract surgery outside of a randomized clinical trial setting.

DESIGN

Single-surgeon consecutive case series.

PARTICIPANTS

Glaucomatous eyes that underwent implantation of a Hydrus microstent with concomitant cataract surgery at a single ophthalmology center in Montreal, Canada.

METHODS

Success was defined according to the absence of specific failure criteria: (A) glaucoma reoperation; (B) selective laser trabeculoplasty; (C) intraocular pressure (IOP) < 5 mmHg, > 18 mmHg, or increase in the number of antiglaucoma medications (AGMs) used (after the first postoperative month), or loss of light perception due to glaucoma; (D) aggregation of criteria A-C. Predictors of treatment failure and postoperative changes in IOP and AGM use were assessed. Safety included best-corrected visual acuity (BCVA), cup-to-disc ratio (CDR), retinal nerve fiber layer (RNFL) thickness, ganglion cell inner plexiform layer (GC-IPL) thickness, visual field mean deviation (VF-MD) and pattern standard deviation (VF-PSD), and adverse events.

MAIN OUTCOME MEASURES

Surgical success, predictors of treatment failure, postoperative changes in IOP and AGM use, and structural and functional markers of disease stability.

RESULTS

One hundred six eyes were included. The 3-year surgical success according to Criteria A to D was 86%, 83%, 91%, and 67%, respectively. Intraocular pressure decreased by 26.5% from 18.9 ± 4.8 to 13.9 ± 2.3 mmHg (P < 0.001) and AGM use reduced by 33% from 3.0 ± 1.2 to 2.0 ± 1.2 medications (P < 0.001). The postoperative improvement in BCVA was preserved (P < 0.001). The structural and functional markers of disease stability, including CDR, RNFL, and GC-IPL thickness, as well as VF-MD and VF-PSD, remained stable (P > 0.05). Postoperative adverse events were few and transient.

CONCLUSIONS

The 36-month results from this study show that the Hydrus microstent with phacoemulsification is safe and effective in reducing the IOP and AGM among patients with mild to severe open-angle glaucoma and can slow down the disease progression by preserving both structural and functional parameters.

FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

摘要

目的

HORIZON 试验已经报道了 Hydrus 微支架的中远期结果。然而,在随机临床试验之外,尚未报告超过 24 个月的结果。在这里,我们在随机临床试验之外,检查了 Hydrus 微支架与白内障手术联合应用的 3 年结果。

设计

单外科医生连续病例系列。

参与者

在加拿大蒙特利尔的一家眼科中心进行 Hydrus 微支架植入和同时行白内障手术的青光眼眼。

方法

根据是否存在特定的失败标准来定义成功:(A)青光眼再次手术;(B)选择性激光小梁成形术;(C)眼压(IOP)<5mmHg,>18mmHg,或抗青光眼药物(AGM)使用增加(术后第一个月后),或因青光眼导致光感丧失;(D)标准 A-C 的组合。评估了治疗失败的预测因素以及术后 IOP 和 AGM 使用的变化。安全性包括最佳矫正视力(BCVA)、杯盘比(CDR)、视网膜神经纤维层(RNFL)厚度、节细胞内丛状层(GC-IPL)厚度、视野平均偏差(VF-MD)和模式标准偏差(VF-PSD),以及不良事件。

主要观察指标

手术成功率、治疗失败的预测因素、术后 IOP 和 AGM 使用的变化以及疾病稳定性的结构和功能标志物。

结果

共纳入 106 只眼。根据标准 A 至 D,3 年手术成功率分别为 86%、83%、91%和 67%。眼压从 18.9±4.8mmHg 下降到 13.9±2.3mmHg(P<0.001),AGM 使用减少了 33%,从 3.0±1.2 种药物减少到 2.0±1.2 种药物(P<0.001)。术后视力改善得以维持(P<0.001)。疾病稳定性的结构和功能标志物,包括 CDR、RNFL 和 GC-IPL 厚度,以及 VF-MD 和 VF-PSD,均保持稳定(P>0.05)。术后不良事件较少且短暂。

结论

本研究 36 个月的结果表明,在轻度至重度开角型青光眼患者中,超声乳化白内障吸除术联合 Hydrus 微支架是安全有效的,可以通过维持结构和功能参数来减缓疾病进展。

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