Ahmed ClearPath 与 Baerveldt 青光眼植入物:回顾性非劣效性比较研究

IF 2.8 Q1 OPHTHALMOLOGY Ophthalmology. Glaucoma Pub Date : 2024-05-01 DOI:10.1016/j.ogla.2023.12.006
Wesam Shamseldin Shalaby MD , Rohit Reddy BS , Brandon Wummer MD , Ping Huang MD , Daniel Lee MD , Reza Razeghinejad MD , Michael J. Pro MD
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引用次数: 0

摘要

目的:比较两种无瓣青光眼引流装置(GDD)的疗效和安全性:设计:单中心回顾性比较研究:设计:单中心、回顾性、比较研究:因青光眼(250 mm2 或 350 mm2 模型)接受 ACP 或 BGI 手术的连续患者,随访时间≥6 个月且之前未植入过 GDD:威尔斯眼科医院青光眼患者 ACP 或 BGI 手术的病历回顾(2020-2023 年):主要结果指标是随访结束时的手术失败,定义为眼压(IOP)>21或结果:共纳入 113 名患者(63 名 ACP,65 名 BGI)的 128 只眼睛,这些患者的基线特征相似,平均随访时间为 19.6±10.8(中位数 20.5)个月。12眼(9.4%)手术失败,ACP和BGI眼之间无明显差异(分别为9.5%对9.2%;P=0.810)。失败原因包括眼压>21 mmHg(3/12,25.0%)、青光眼再次手术(5/12,41.7%)和拔管(4/12,33.3%)。没有眼球发展为 NLP 视力。卡普兰-米尔生存分析显示,两组患者的手术失败累积率相似(P=0.871)。与基线相比,两组患者的眼压和用药量都有明显下降。两组的最终眼压、BCVA 和并发症发生率相似,但 ACP 组的用药次数明显较少(P=0.012)。250 mm2 和 350 mm2 型号的结果相似,但复视与任一植入物的 350 mm2 型号有显著相关性(P=0.012)。单变量逻辑回归分析并未发现导管类型或植入板尺寸是手术失败的预测因素:据我们所知,这是第一项比较最近批准的 ACP 与 BGI 的研究。两种植入物的手术失败率和并发症发生率相似。两组的最终眼压相似,但ACP的用药次数更少。复视与使用 350 mm2 型号的植入体有明显关系。植入管类型和植入板大小都不是手术失败的重要预测因素。
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Ahmed ClearPath vs. Baerveldt Glaucoma Implant

Purpose

To compare the efficacy and safety of 2 nonvalved glaucoma drainage devices (GDDs): Ahmed ClearPath (ACP) vs. Baerveldt glaucoma implant (BGI).

Design

Single-center, retrospective, comparative study.

Participants

Consecutive patients who underwent ACP or BGI surgery for glaucoma (250 mm2 or 350 mm2 models), had ≥ 6 months of follow-up, and no prior GDD implantation.

Methods

Chart review of ACP or BGI surgery in patients with glaucoma at Wills Eye Hospital (2020–2023).

Main Outcome Measures

The primary outcome measure was surgical failure at the end of follow-up, defined as intraocular pressure (IOP) > 21 or < 6 mmHg at 2 consecutive visits, progression to no light perception (NLP) vision, glaucoma reoperation, or implant removal. Secondary outcome measures included the rate of postoperative complications and changes in best corrected visual acuity (BCVA), IOP, and glaucoma medications.

Results

A total of 128 eyes of 113 patients (63 ACP, 65 BGI) with similar baseline characteristics and a mean follow-up duration of 19.6 ± 10.8 (median 20.5) months were included. Surgical failure occurred in 12 eyes (9.4%) with no significant difference between ACP and BGI eyes (9.5% vs. 9.2%, respectively; P = 0.810). Reasons for failure included IOP > 21 mmHg (3/12, 25.0%), glaucoma reoperation (5/12, 41.7%), and tube removal (4/12, 33.3%). No eyes progressed to NLP vision. Kaplan–Meier survival analysis showed similar cumulative rate of surgical failure in both groups (P = 0.871). Both groups achieved significant IOP and medication reduction compared to their baseline. Final IOP, BCVA, and complication rates were similar in both groups, but medication number was significantly lower in the ACP group (P = 0.012). Both the 250 mm2 and 350 mm2 models had similar outcomes, but diplopia was significantly associated with the 350 mm2 model of either implant (P = 0.012). Univariate logistic regression analysis did not identify either tube type or plate size as predictors of surgical failure.

Conclusions

This study compares the recently approved ACP vs. BGI. Both implants had similar surgical failures and complication rates. Final IOP was similar in both groups, but ACP achieved lower medication number. Diplopia was significantly associated with the use of 350 mm2 model of either implant. Neither tube type nor plate size were significant predictors of surgical failure.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

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来源期刊
Ophthalmology. Glaucoma
Ophthalmology. Glaucoma OPHTHALMOLOGY-
CiteScore
4.80
自引率
6.90%
发文量
140
审稿时长
46 days
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