Manchester Royal Eye Hospital, Manchester University NHS Foundation Trust, Manchester, UK.
Ophthalmology Unit, Department of Ophthalmology and ORL, Faculty of Medicine, Hospital Clinico San-Carlos, Universidad Complutense de Madrid, Instituto de Investigacion Sanitaria del Hospital Clinico San-Carlos (IdISSC), Madrid, Spain.
Eye (Lond). 2023 Mar;37(4):644-649. doi: 10.1038/s41433-022-01995-7. Epub 2022 Mar 12.
BACKGROUND/AIMS: To evaluate 1-year success rates and safety profile of Preserflo™ Microshunt in glaucoma patients.
Retrospective multicentre cohort study of 100 consecutive eyes (91 patients) from four tertiary-referral glaucoma centres. Four intraocular pressure (IOP) criteria were defined: A: IOP ≤ 21 mmHg+IOP reduction ≥20% from baseline; B: IOP ≤ 18 mmHg+IOP reduction ≥20%; C: IOP ≤ 15 mmHg+IOP reduction ≥25%; D: IOP≤12 mmHg+IOP reduction ≥30%. Success was defined as qualified or complete based on whether reached with or without medication. Primary outcome was success according to the above criteria. Secondary outcomes included: IOP, best-corrected visual acuity (BCVA), medication use, complications, postoperative interventions, and failure-associated factors.
Qualified and complete success rates (95% CI) at 12 months were 74%(66-83%) and 58%(49-69%) for criterion A, 72%(63-82%) and 57%(48-68%) for B, 52%(43-63%) and 47%(38-58%) for C, 29%(21-40%) and 26%(19-36%) for D. Overall median (interquartile range (IQR)) preoperative IOP decreased from 21.5(19-28) mmHg to 13(11-16) mmHg at 12 months. BCVA was not significantly different up to 12 months (p = 0.79). Preoperative median (IQR) number of medications decreased from 3 (2-3) to 0 (0-1) at 12 months. Twelve eyes underwent needling, five surgical revision and one device removal due to corneal oedema. There were no hypotony-related complications. Non-Caucasian ethnicity was the only risk factor consistently associated with increased failure.
Preserflo™ Microshunt is a viable surgical option in glaucoma patients, with reasonable short-term success rates, decreased medications use, excellent safety profile, smooth postoperative care, and rapid learning curve. Success rates for the most stringent IOP cutoffs were modest, indicating that it may not be the optimal surgery when very low target IOP is required.
背景/目的：评估 Preserflo™ 微分流器在青光眼患者中的 1 年成功率和安全性。
这是一项回顾性多中心队列研究，纳入了来自四家三级转诊青光眼中心的 100 只连续眼（91 例患者）。定义了 4 个眼压（IOP）标准：A：IOP≤21mmHg+基线时 IOP 降低≥20%；B：IOP≤18mmHg+IOP 降低≥20%；C：IOP≤15mmHg+IOP 降低≥25%；D：IOP≤12mmHg+IOP 降低≥30%。成功的定义是基于有无药物使用而达到标准的合格或完全。主要结局是根据上述标准评估的成功率。次要结局包括：IOP、最佳矫正视力（BCVA）、药物使用、并发症、术后干预和与失败相关的因素。
12 个月时，标准 A 的合格和完全成功率（95%置信区间）分别为 74%（66-83%）和 58%（49-69%），标准 B 分别为 72%（63-82%）和 57%（48-68%），标准 C 分别为 52%（43-63%）和 47%（38-58%），标准 D 分别为 29%（21-40%）和 26%（19-36%）。总体而言，中位（四分位距（IQR））术前 IOP 从 21.5（19-28）mmHg 降至 12 个月时的 13（11-16）mmHg。12 个月时 BCVA 无显著差异（p=0.79）。术前中位（IQR）药物数量从 3（2-3）种减少至 12 个月时的 0（0-1）种。12 只眼因角膜水肿行针刺、5 只眼行手术修正、1 只眼行器械去除。无低眼压相关并发症。非白种人种族是与失败风险增加一致相关的唯一危险因素。
Preserflo™ 微分流器是青光眼患者的一种可行的手术选择，具有合理的短期成功率、减少药物使用、良好的安全性、术后护理简单、学习曲线陡峭。对于最严格的 IOP 截止值，成功率适中，表明当需要非常低的目标 IOP 时，它可能不是最佳手术。
