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iStent inject 小梁微分流控植入物联合局部前列腺素治疗开角型青光眼:4 年随访结果。

iStent inject trabecular micro-bypass stents with topical prostaglandin as standalone treatment for open-angle glaucoma: 4-year outcomes.

机构信息

Vance Thompson Vision, Sioux Falls, South Dakota, USA.

S.V. Malayan Ophthalmology Centre, Yerevan, Armenia.

出版信息

Clin Exp Ophthalmol. 2020 Aug;48(6):767-774. doi: 10.1111/ceo.13763. Epub 2020 May 12.

DOI:10.1111/ceo.13763
PMID:32311201
Abstract

IMPORTANCE

Long-term data are needed regarding effective and safe glaucoma treatment modalities.

BACKGROUND

This study evaluated 4-year outcomes of second-generation trabecular micro-bypass stent implantation (iStent inject) combined with topical travoprost in open-angle glaucoma (OAG).

DESIGN

Prospective, non-randomized, multi-surgeon study at a tertiary care ophthalmology centre.

PARTICIPANTS

OAG subjects with preoperative intraocular pressure (IOP) 18 to 30 mmHg on two medications and 22 to 38 mmHg post-washout.

METHODS

Subjects (n = 53) underwent standalone iStent inject implantation and started travoprost on postoperative Day 1. Measures included IOP, medications, comprehensive ophthalmic examinations and testing, and adverse events (AEs). Annual medication washouts were performed.

MAIN OUTCOME MEASURES

Mean medicated and unmedicated IOP; and proportions of eyes with IOP ≤18mmHg, ≤15 mmHg, or ≥20% reduced while on travoprost vs screening IOP on two medications.

RESULTS

At 48 months postoperative, 85% of eyes reduced IOP ≥20% on travoprost vs screening IOP on 2 medications; 92% of eyes had IOP ≤18 mmHg on travoprost; and 83% had IOP ≤15 mmHg on travoprost. At Month 49 (post-washout), 90% of eyes reduced IOP ≥20% vs preoperative washout IOP. Throughout follow-up, mean IOP on travoprost was 11.9 to 13.0 mmHg (34%-40% reduced vs 19.7 mmHg on 2 medications preoperatively; P < .0001 throughout), and post-washout IOP was 16.5 to 17.7 mmHg (28%-34% reduced vs 24.9 mmHg preoperatively; P < .0001 throughout). Favourable safety included minimal AEs; stable visual acuity, cup-to-disc ratio and visual fields; and no secondary surgeries.

CONCLUSIONS AND RELEVANCE

Combining iStent inject implantation with topical prostaglandin produced significant and safe 4-year IOP and medication reductions in OAG.

摘要

重要性

需要长期数据来评估有效的和安全的青光眼治疗方式。

背景

本研究评估了二代小梁微管旁路支架植入(iStent inject)联合局部曲伏前列素在开角型青光眼(OAG)中的 4 年结果。

设计

前瞻性、非随机、多外科医生在三级眼科中心进行的研究。

参与者

术前眼压(IOP)为 18 至 30mmHg 的 OAG 患者,使用两种药物治疗,洗脱后眼压为 22 至 38mmHg。

方法

受试者(n=53)行单独的 iStent inject 植入,并在术后第 1 天开始使用曲伏前列素。测量包括眼压、药物、全面眼科检查和测试以及不良事件(AE)。每年进行药物洗脱。

主要观察指标

平均药物和非药物治疗的眼压;与术前使用两种药物治疗时的筛查眼压相比,接受曲伏前列素治疗的眼睛中眼压≤18mmHg、≤15mmHg 或降低≥20%的比例。

结果

术后 48 个月时,85%的眼睛在使用曲伏前列素治疗时眼压降低≥20%,与术前使用两种药物治疗时的筛查眼压相比;92%的眼睛在使用曲伏前列素治疗时眼压≤18mmHg;83%的眼睛在使用曲伏前列素治疗时眼压≤15mmHg。在第 49 个月(洗脱后),与术前洗脱时的眼压相比,90%的眼睛眼压降低≥20%。在整个随访过程中,曲伏前列素治疗的平均眼压为 11.9 至 13.0mmHg(与术前使用两种药物治疗时的 19.7mmHg 相比降低 34%至 40%;P<0.0001),洗脱后眼压为 16.5 至 17.7mmHg(与术前使用两种药物治疗时的 24.9mmHg 相比降低 28%至 34%;P<0.0001)。有利的安全性包括最小的不良事件;稳定的视力、杯盘比和视野;且无二次手术。

结论和相关性

在 OAG 中,iStent inject 植入联合局部前列腺素治疗可显著且安全地降低眼压和减少用药 4 年。

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