Comparative Study of Early Safety and Effectiveness Outcomes of the PreserFlo MicroShunt with and without an Intraluminal Suture Stent

IF 3.2 Q1 OPHTHALMOLOGY

Ophthalmology. Glaucoma Pub Date : 2025-07-01 DOI:10.1016/j.ogla.2025.03.003

Jason Chami MD , Jeremy C.K. Tan MD, FRANZCO , David Manning FRANZCO , George Kong FRANZCO, PhD , Jason Cheng FRANZCO, FRCOphth , Hamish Dunn FRANZCO, PhD , Anna Galanopoulos FRANZCO , Brian Chua FRANZCO, MPH , Joanne Thai MD , Mark Hassall FRANZCO, DPhil (Oxon) , Jamie E. Craig FRANZCO, DPhil , Mitchell Lawlor FRANZCO, PhD

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Abstract

Objective

To assess the early safety and effectiveness outcomes of the PreserFlo MicroShunt with and without an intraluminal suture stent.

Design

Multicenter observational retrospective study using data from the Fight Glaucoma Blindness registry.

Participants

A total of 183 eyes in 172 patients, with a mean age of 73 ± 14 years, who underwent PreserFlo MicroShunt surgery with/without intraluminal stent suture placement, and with at least 6 months of follow-up. Eyes were divided into 2 groups: stent (68 eyes) and no-stent (115 eyes).

Methods

Baseline and postoperative measurements of intraocular pressure (IOP), visual acuity (VA), number of glaucoma medications, and adverse events were recorded at 1, 3, and 6 months. Outcomes were compared between stent and no-stent groups using t tests for continuous variables and Fisher exact tests for categorical variables.

Main Outcome Measures

The primary outcome measures were the incidence of numerical hypotony (IOP ≤ 5 mmHg) and symptomatic hypotony (numerical hypotony plus ≥10 letters of VA loss) within 1 month, 1 to 3 months, and 3 to 6 months postoperatively. Secondary outcome measures included surgical success rates (defined as IOP ≤12, ≤15, ≤18, or ≤21 mmHg and ≥20% IOP reduction without hypotony and without additional glaucoma medications) and the need for secondary surgical interventions.

Results

In the first postoperative month, the stent group had significantly lower rates of numerical hypotony (24% vs. 44%; P = 0.007) and symptomatic hypotony (13% vs. 28%; P = 0.027) than the no-stent group. The rate of device revision, explant, or replacement with an alternative shunt was also significantly lower in the stent group (3 eyes; 4.4%) than in the no-stent group (17 eyes; 14.8%; P = 0.047). No significant differences in hypotony rates were observed in the later follow-up windows (1–3 and 3–6 months), nor were there significant differences in surgical success rates between the stent and no-stent groups at any time point.

Conclusions

The use of an intraluminal suture stent in PreserFlo MicroShunt surgery reduces the incidence of early hypotony without compromising surgical success. These findings suggest that routine use of intraluminal sutures may improve early postoperative safety.

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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PreserFlo MicroShunt与不带腔内缝合支架的早期安全性和有效性比较研究。

目的：评价PreserFlo MicroShunt合并和不合并腔内缝合支架的早期安全性和有效性。设计：多中心观察性回顾性研究，使用来自抗击青光眼失明登记的数据。参与者：172例患者共183只眼，平均年龄73±14岁，接受PreserFlo MicroShunt手术，伴/不伴腔内支架缝合线放置，随访至少6个月。眼分为支架组（68眼）和非支架组（115眼）。方法：-分别于1、3、6个月记录基线及术后眼压、视力、青光眼药物使用次数及不良事件。使用连续变量的t检验和分类变量的Fisher精确检验比较支架组和非支架组的结果。主要观察指标：主要观察指标为术后1个月、1-3个月和3-6个月的数值低视（IOP≤5 mmHg）和症状性低视（数值低视加视力下降≥10个字母）的发生率。次要结局指标包括手术成功率（定义为IOP≤12，≤15,≤18，或≤21 mmHg， IOP降低≥20%，无低眼压和无额外青光眼药物治疗）和二次手术干预的必要性。结果：在术后第一个月，支架组的数值低视率显著降低(24% vs 44%；P = 0.007)和症状性精神低下(15% vs 30%；P = 0.04)。支架组的装置翻修、移植或替代分流器的比率也显著降低(3眼；4.4%)，而无支架组(17只眼；14.8%;P = 0.047)。在随后的随访窗口（1-3个月和3-6个月）中，观察到低体温率无显著差异，在任何时间点，支架组和非支架组的手术成功率也无显著差异。结论：在PreserFlo MicroShunt手术中使用腔内缝合支架可以在不影响手术成功的情况下减少早期低斜压的发生率。这些发现提示常规使用腔内缝合可提高早期术后安全性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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