Guedes Ricardo Augusto Paletta, Gravina Daniela Marcelo, Guedes Vanessa Maria Paletta, Moraes Daniel Augusto Guedes, Chaoubah Alfredo
Universidade Federal de Juiz de Fora, Juiz de Fora, MG, Brazil.
Instituto de Olhos Paletta Guedes, 79, Oscar Vidal Street, Juiz de Fora, MG, 36010-060, Brazil.
Ophthalmol Ther. 2025 Jun;14(6):1219-1235. doi: 10.1007/s40123-025-01134-x. Epub 2025 Apr 7.
Minimally invasive glaucoma surgery (MIGS) has become more widespread in open-angle glaucoma (OAG) management. Broad evidence has shown a greater decrease in mean intraocular pressure (IOP) when cataract surgery is combined with MIGS, compared with cataract surgery alone. In this study, we evaluated the effectiveness and safety of second-generation trabecular micro-bypass implantation (iStent inject®) either in combination with cataract surgery (Combined subgroup) or as a standalone procedure (Standalone subgroup) in eyes with OAG. Our hypothesis was that implementing interventional glaucoma management would provide meaningful reductions in IOP and topical medication burden.
This long-term retrospective consecutive case series included patients with mild to moderate OAG who received the iStent inject® Trabecular Micro-bypass stent with or without phacoemulsification between 2018 and 2024. Eligible patients were ≥ 18 years of age with mild or moderate OAG, cataract requiring surgery (for the Combined subgroup), and the need for IOP and/or medication reduction. Study outcomes included mean and proportional analyses of IOP and medications over time. Analyses were completed for the overall population and for the Combined/Standalone and Mild/Moderate subgroups.
The study included 271 eyes with mean age 69 years and a mean of 40 months of follow-up (range 10-79 months). In the overall population, mean IOP decreased from 16.4 mmHg at baseline to 13.7 mmHg at last follow-up (p = 0.001), while the mean number of medications decreased from 2.24 at baseline to 0.62 at last follow-up (p = 0.001). IOP reductions were also significant in the Combined/Standalone subgroups and in the Mild/Moderate subgroups (p = 0.001 for all), and all subgroups experienced increased proportions of eyes on no topical medications at last follow-up versus preoperative (p = 0.001 for all).
This 5-year real-world study showed significant and sustained reductions in IOP and topical medication burden following iStent inject trabecular micro-bypass with or without cataract surgery in eyes with mild and moderate open-angle glaucoma.
微创青光眼手术（MIGS）在开角型青光眼（OAG）的治疗中已变得更为普遍。大量证据表明，与单纯白内障手术相比，白内障手术联合MIGS时平均眼压（IOP）降低幅度更大。在本研究中，我们评估了第二代小梁微旁路植入术（iStent inject®）在OAG患者中与白内障手术联合应用（联合亚组）或作为独立手术（独立亚组）的有效性和安全性。我们的假设是，实施介入性青光眼治疗将使眼压和局部用药负担显著降低。
本长期回顾性连续病例系列纳入了2018年至2024年间接受iStent inject®小梁微旁路支架植入术（无论是否联合超声乳化白内障吸除术）的轻至中度OAG患者。符合条件的患者年龄≥18岁，患有轻至中度OAG，需要进行白内障手术（联合亚组），且需要降低眼压和/或减少用药。研究结局包括眼压和药物随时间的均值及比例分析。对总体人群以及联合/独立和轻度/中度亚组进行了分析。
该研究纳入了271只眼，平均年龄69岁，平均随访40个月（范围10 - 79个月）。在总体人群中，平均眼压从基线时的16.4 mmHg降至最后一次随访时的13.7 mmHg（p = 0.001），而平均用药数量从基线时的2.24种降至最后一次随访时的0.62种（p = 0.001）。联合/独立亚组以及轻度/中度亚组的眼压降低也具有显著性（所有p = 0.001），并且所有亚组在最后一次随访时与术前相比，未使用局部药物的眼比例均增加（所有p = 0.001）。
这项为期5年的真实世界研究表明，在轻度和中度开角型青光眼患者中，无论是否联合白内障手术，iStent inject小梁微旁路植入术后眼压和局部用药负担均显著且持续降低。
