EX-PRESS 青光眼引流阀与 Esnoper 植入物的非穿透性深层巩膜切除术联合治疗开角型青光眼：一项前瞻性随机研究。

The EX-PRESS glaucoma shunt versus nonpenetrating deep sclerectomy with Esnoper implant in combined surgery for open-angle glaucoma: a prospective randomized study.

机构信息

Department of Glaucoma, Institute Catalan of Retina, International University of Catalunya, Barcelona, Spain.

Department of Ophthalmology, Esperanza Hospital, Barcelona, Spain.

出版信息

Acta Ophthalmol. 2019 Nov;97(7):e952-e961. doi: 10.1111/aos.14023. Epub 2019 Feb 3.

DOI:10.1111/aos.14023

PMID:30714336

Abstract

PURPOSE

To report 1-year treatment outcomes of P50 EX-PRESS implant versus nonpenetrating deep sclerectomy (NPDS) with Esnoper V2000 combined with phacoemulsification.

DESIGN

Randomized, prospective and multicentre clinical trial.

METHODS

Settings: Six clinical centres.

POPULATION

Patients 54-89 years of age without previous filtering surgery with cataract and glaucoma who required lower levels of intraocular pressure (IOP).

INTERVENTIONS

Phaco-EX-PRESS P50 or Phaco-NPDS with Esnoper V2000, both groups with mitomycin C (0.2 mg/ml for 2 min).

MAIN OUTCOME MEASURES

IOP, complete success rate (IOP: ≥6 and ≤18 mmHg), visual acuity, use of medical therapy and systematic assessment of complications and postoperative interventions.

RESULTS

A total of 98 eyes were enrolled, including 50 in the EX-PRESS group and 48 in the NPDS group. At 12 months, IOP (mean ± SD) was 13.9 ± 3.3 mmHg in EX-PRESS group and 13.3 ± 3.6 mmHg in NPDS group (p = 0.38). Success rate was 75% and 80% in EX-PRESS and NPDS groups, respectively (p = 0.53). The number of glaucoma medications (mean ± SD) was 0.2 ± 0.55 in EX-PRESS group and 0.17 ± 0.44 in NPDS group (p = 1.00). The total number of complications was 66 in 35 subjects in EX-PRESS group and 39 in 23 subjects in NPDS group (p = 0.02). The incidence of more than one complication was n = 13 (26%) versus n = 9 (18.8%) in EX-PRESS and NPDS groups, respectively (p = 0.38). The total number of required postoperative interventions was 59 and 26 in EX-PRESS and NPDS groups, respectively (p = 0.01). Visual acuity was similar in both groups at month 12 (p = 0.13). Surgical time (mean ± SD) was 52.6 ± 13.6 min in EX-PRESS group and 63.3 ± 19.4 min in NPDS group (p = 0.01).

CONCLUSION

Phaco-EX-PRESS surgery had similar success rate compared to Phaco-NPDS during 1 year of follow-up. Both procedures were associated with similar IOP reduction and use of additional medical therapy at 12 months. EX-PRESS surgery required more postoperative interventions and had more complications, but needed less surgical time compared to NPDS.

摘要

目的

报告 P50 EX-PRESS 植入物与非穿透性深层巩膜切除术（NPDS）联合 Esnoper V2000 行超声乳化白内障吸除术的 1 年治疗结果。

设计

随机、前瞻性、多中心临床试验。

方法

设置：六个临床中心。

人群

年龄在 54-89 岁之间、没有既往滤过手术史、患有白内障和青光眼、需要较低眼内压（IOP）的患者。

干预

超声乳化白内障吸除术联合 P50 EX-PRESS 或 NPDS 联合 Esnoper V2000，两组均使用丝裂霉素 C（0.2mg/ml，2 分钟）。

主要观察指标

IOP、完全成功率（IOP：≥6 且≤18mmHg）、视力、药物治疗的使用以及对并发症和术后干预的系统评估。

结果

共有 98 只眼入组，其中 EX-PRESS 组 50 只眼，NPDS 组 48 只眼。在 12 个月时，EX-PRESS 组的 IOP（均值±标准差）为 13.9±3.3mmHg，NPDS 组为 13.3±3.6mmHg（p=0.38）。EX-PRESS 组和 NPDS 组的成功率分别为 75%和 80%（p=0.53）。EX-PRESS 组的青光眼药物使用数量（均值±标准差）为 0.2±0.55，NPDS 组为 0.17±0.44（p=1.00）。EX-PRESS 组有 35 例受试者共发生 66 例并发症，NPDS 组有 23 例受试者共发生 39 例并发症（p=0.02）。EX-PRESS 组和 NPDS 组分别有 13 例（26%）和 9 例（18.8%）受试者发生不止一种并发症（p=0.38）。EX-PRESS 组和 NPDS 组分别有 59 例和 26 例需要进行术后干预（p=0.01）。两组在 12 个月时的视力相似（p=0.13）。EX-PRESS 组的手术时间（均值±标准差）为 52.6±13.6 分钟，NPDS 组为 63.3±19.4 分钟（p=0.01）。