Cagini Carlo, Boni Niccolò, Bonifazi Tommaso, Fruttini Daniela, Della Lena Francesco
University of Perugia School of Medicine and Surgery Department of Medicine and Surgery Section of Ophthalmology Ospedale S. Maria della Misericordia, Perugia 06156, Italy.
J Ophthalmol. 2024 Jul 23;2024:2447721. doi: 10.1155/2024/2447721. eCollection 2024.
The primary objective of this study is to evaluate the efficacy and safety profile of PreserFlo MicroShunt implantation in the medium- to long-term follow-up of patients with open-angle glaucoma. The secondary objective is to analyze laser flare meter (LFM) values before and after PreserFlo MicroShunt implantation.
This prospective, observational, longitudinal single-center study included a total of 62 eyes from 54 patients. A subgroup of 27 eyes (26 patients) reached the 12-month follow-up. Success was defined based on three criteria: criterion A: IOP ≤21 mmHg and ≥20% reduction; criterion B: IOP ≤15 mmHg and ≥25% reduction; and criterion C: IOP ≤12 mmHg and ≥30% reduction. Success was further categorized as complete if achieved without IOP-lowering medications and qualified if achieved with medication administration. Other aspects evaluated included the number of IOP-lowering medications (baseline and postoperative), development of postoperative complications, 5-FU injections or implant revision, and LFM values.
The 12-month follow-up group (27 patients) was composed by 50% males and had a mean age of 75.54 ± 9.98 years. Success rates at 12 months were as follows: 78% for criterion A, 56% for criterion B, and 26% for criterion C. Complete success, as defined by criterion A, was achieved by 67% of the patients, 29% achieved qualified success, and one eye (4%) experienced failure. IOP decreased from 25.26 ± 1.67 mmHg at baseline to 14.81 ± 0.74 mmHg at 12 months. The number of medications decreased from 3.67 ± 1.30 at baseline to 0.48 ± 0.75 at 12 months. Reported complications were choroidal detachment (11%), hyphema (5%), and athalamia (flat anterior chamber) (2%) 13 eyes (48%) received 5-FU injections, while 7 eyes (26%) underwent implant revision. No significant increase in LFM values was observed. Eyes with a regular postoperative course and IOP ≤15 mmHg showed significantly lower LFM values than patients with unfavorable outcomes (IOP >15 mmHg, development of complications, 5-FU injection, or implant revision).
PreserFlo MicroShunt showed a significant reduction in IOP and a decrease in the number of IOP-lowering medications. Complications occurred at a modest frequency. The implant provides a minimally invasive approach with no significant increases in LFM values postoperatively. Higher LFM values correlate with unfavorable postoperative outcomes.
本研究的主要目的是评估PreserFlo微型分流器植入术在开角型青光眼患者中长期随访中的疗效和安全性。次要目的是分析PreserFlo微型分流器植入术前和术后的激光 flare 仪（LFM）值。
这项前瞻性、观察性、纵向单中心研究共纳入了54例患者的62只眼睛。27只眼睛（26例患者）的亚组完成了12个月的随访。成功的定义基于三个标准：标准A：眼压≤21 mmHg且降低≥20%；标准B：眼压≤15 mmHg且降低≥25%；标准C：眼压≤12 mmHg且降低≥30%。如果在未使用降眼压药物的情况下达到成功，则进一步分类为完全成功；如果在使用药物的情况下达到成功，则分类为合格成功。评估的其他方面包括降眼压药物的数量（基线和术后）、术后并发症的发生、5-氟尿嘧啶注射或植入物翻修，以及LFM值。
12个月随访组（27例患者）中男性占50%，平均年龄为75.54±9.98岁。12个月时的成功率如下：标准A为78%，标准B为56%，标准C为26%。按照标准A定义的完全成功由67%的患者实现，29%的患者实现了合格成功，一只眼睛（4%）出现失败。眼压从基线时的25.26±1.67 mmHg降至12个月时的14.81±0.74 mmHg。药物数量从基线时的3.67±1.30降至12个月时的0.48±0.75。报告的并发症有脉络膜脱离（11%）、前房积血（5%）和无前房（扁平前房）（2%）。13只眼睛（48%）接受了5-氟尿嘧啶注射，而7只眼睛（26%）进行了植入物翻修。未观察到LFM值有显著增加。术后病程正常且眼压≤15 mmHg的眼睛的LFM值明显低于预后不良的患者（眼压>15 mmHg、出现并发症、5-氟尿嘧啶注射或植入物翻修）。
PreserFlo微型分流器显示眼压显著降低，降眼压药物数量减少。并发症发生频率适中。该植入物提供了一种微创方法，术后LFM值无显著增加。较高的LFM值与不良的术后预后相关。
