Oklahoma Eye Surgeons, PLLC, Oklahoma City, OK.
Glaucoma Associates of Texas, Dallas.
J Glaucoma. 2023 Jan 1;32(1):9-18. doi: 10.1097/IJG.0000000000002141. Epub 2022 Oct 20.
The iStent Infinite Trabecular Micro-Bypass System implanted in patients with open angle glaucoma (OAG) (uncontrolled by prior surgical or medical therapy) was effective in reducing mean diurnal intraocular pressure with a favorable safety profile.
The purpose of this study is to evaluate safety and effectiveness of the iStent infinite Trabecular Micro-Bypass System in patients with OAG uncontrolled by prior surgical or medical therapy.
Prospective, multicenter, single-arm, open-label clinical trial.
Implantation of iStent infinite (3 iStent inject W stents) was performed as a stand-alone surgical procedure in eyes with OAG uncontrolled by prior incisional or cilioablative surgeries or maximum tolerated medical therapy (MTMT). Prospectively declared effectiveness endpoints were proportion of eyes achieving ≥20% mean diurnal intraocular pressure (MDIOP) reduction from baseline at month 12 on the same or fewer intraocular pressure (IOP)-lowering medication classes (responder endpoint) and mean change in MDIOP from baseline at month 12. Safety parameters included visual acuity, slit-lamp and fundus examinations, gonioscopy, perimetry, surgical complications, and adverse events.
Seventy-two eyes of 72 patients (mean age 71.9 y) with preoperative mean medicated MDIOP of 23.4±2.8 mm Hg on a mean of 3.1±0.9 IOP-lowering medication classes were enrolled: 61 eyes with failed prior surgery/ies (Failed-Surgery subgroup) and 11 eyes uncontrolled on MTMT (MTMT subgroup). A total of 76.1% of all enrolled patients met the responder endpoint (73.4% Failed-Surgery, 90.9% MTMT), with mean reduction (SE) in MDIOP at month 12 of 5.9(0.6) mm Hg [5.5(0.7) mm Hg Failed-Surgery subgroup, 8.1(0.9) mm Hg MTMT subgroup]. For patients on the same or fewer medication(s) as baseline, 53.0% achieved ≥30% MDIOP reduction without surgical interventions/other events. Safety was favorable, with no explants, infection, or device-related interventions or hypotony.
iStent infinite stand-alone surgery achieved clinically significant IOP reduction and favorable safety in patients with OAG uncontrolled by prior therapy.
植入患有开角型青光眼（OAG）（先前手术或药物治疗未控制）患者的 iStent Infinite 小梁微旁路系统可有效降低日间平均眼内压，且安全性良好。
本研究旨在评估 iStent Infinite 小梁微旁路系统在先前手术或药物治疗未控制的开角型青光眼患者中的安全性和有效性。
前瞻性、多中心、单臂、开放标签临床试验。
在先前的切口或睫状体破坏性手术或最大耐受药物治疗（MTMT）未控制的 OAG 眼中，作为独立手术植入 iStent Infinite（3 个 iStent inject W 支架）。预先宣布的有效性终点是在第 12 个月时，相同或更少的眼压（IOP）降低药物类别（应答终点）中，有多少只眼达到从基线开始的平均日间眼压（MDIOP）降低≥20%，以及从基线开始的第 12 个月时 MDIOP 的平均变化。安全性参数包括视力、裂隙灯和眼底检查、房角镜检查、视野检查、手术并发症和不良事件。
72 名患者的 72 只眼（平均年龄 71.9 岁）纳入研究，术前平均用药 MDIOP 为 23.4±2.8mmHg，平均使用 3.1±0.9 种 IOP 降低药物：61 只眼有先前手术失败（失败手术亚组），11 只眼未控制在 MTMT 上（MTMT 亚组）。所有入组患者中，共有 76.1%达到应答终点（失败手术亚组 73.4%，MTMT 亚组 90.9%），第 12 个月 MDIOP 的平均降低（SE）为 5.9（0.6）mmHg[失败手术亚组 5.5（0.7）mmHg，MTMT 亚组 8.1（0.9）mmHg]。对于与基线相同或更少药物的患者，53.0%的患者无需手术干预/其他事件即可实现 MDIOP 降低≥30%。安全性良好，无移植物、感染或与器械相关的干预或低眼压。
iStent Infinite 独立手术在先前治疗未控制的开角型青光眼患者中实现了显著的眼压降低和良好的安全性。
