Ab interno minimally invasive glaucoma surgery combined with cataract surgery and cataract surgery alone: IRIS® registry study

Michael Mbagwu , Richard Chapman , Kristian Garcia , Cristina Masseria , Jaime E. Dickerson Jr. , Louis B. Cantor
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Abstract

Purpose

Describe real-world characteristics and outcomes in patients undergoing Food and Drug Administration (FDA) approved/cleared ab interno Minimally Invasive Glaucoma Surgery (MIGS) combined with cataract surgery or cataract surgery alone.

Design

An observational, retrospective study of glaucomatous disease treated with MIGS (OMNI® Surgical System, Hydrus®, iStent Inject®) combined with cataract surgery or cataract surgery alone, documented in the American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight).

Methods

The study period was between 07/01/2017 and 12/31/2022. Eligible patients were identified via Current Procedural Terminology (CPT) codes coupled with electronic health records. Outcomes included intraocular pressure (IOP) and IOP-lowering medication class usage over 24 months stratified by baseline IOP (≤18 and >18 mmHg). Bonferroni testing (p < 0.0125) were applied.

Results

Glaucomatous disease was identified for 77,391 (OMNI: 428, Hydrus: 1,435, iStent Inject: 4,769, cataract surgery alone: 70,759) patients (109,745 eyes). For patients with a baseline IOP >18 mmHg, significant (p < 0.001) change in IOP (OMNI −6.64 [SD 7.59], Hydrus −5.71 [6.30], iStent Inject −4.96 [7.30], cataract surgery alone −5.55 [6.41]) and medication usage (OMNI −1.34 [1.48], Hydrus −1.20 [1.18], iStent Inject −0.86 [1.10], cataract surgery alone −0.67 [1.10]) were observed at 24 months. In the baseline IOP ≤18 mmHg subgroup, all cohorts showed significant medication reductions (p < 0.001), with no change in IOP.

Conclusions

MIGS combined with cataract surgery and cataract surgery alone resulted in significant and sustained IOP (baseline IOP >18 mmHg) and medication reductions (both IOP subgroups). As MIGS procedures lead to non-equivalent results, further research will define the role of each in patient subpopulations.

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Ab Interno 微创青光眼手术联合白内障手术与单独白内障手术:IRIS® 登记研究
目的描述接受美国食品和药物管理局(FDA)批准/许可的室内微创青光眼手术(MIGS)联合白内障手术或单独白内障手术的患者的真实世界特征和疗效。设计对美国眼科学会 IRIS® 注册表(Intelligent Research in Sight)中记录的接受微创青光眼手术(OMNI® Surgical System、Hydrus®、iStent Inject®)联合白内障手术或单独白内障手术治疗的青光眼疾病进行观察性、回顾性研究。方法研究期间为 2017 年 1 月 7 日至 2022 年 12 月 31 日。通过当前程序术语 (CPT) 代码和电子健康记录确定符合条件的患者。研究结果包括24个月内的眼压(IOP)和降眼压药物类别使用情况,按基线眼压(≤18和>18 mmHg)进行分层。结果77,391人(OMNI:428人,Hydrus:1,435人,iStent Inject:4,769人,白内障:4,769人)发现患有青光眼(OMNI:428人,Hydrus:1,435人,iStent Inject:4,769人):4,769人,单纯白内障手术:70,759人)的患者(109,745只眼睛)。对于基线眼压为 18 mmHg 的患者,眼压发生了显著变化(p < 0.001)(OMNI -6.64 [SD 7.59],Hydrus -5.71 [6.30],iStent Inject -4.96 [7.30],单纯白内障手术 -5.55 [6.41])和用药情况(OMNI -1.34 [1.48]、Hydrus -1.20 [1.18]、iStent Inject -0.86 [1.10]、单纯白内障手术 -0.67 [1.10])。结论MIGS联合白内障手术和单纯白内障手术可显著、持续地降低眼压(基线眼压18 mmHg)和减少用药(两个眼压亚组)。由于 MIGS 程序导致的结果并不等同,进一步的研究将确定每种程序在患者亚群中的作用。
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