Effectiveness and Safety of iStent Infinite Trabecular Micro-Bypass for Uncontrolled Glaucoma.
Sarkisian Steven R, Grover Davinder S, Gallardo Mark J, Brubaker Jacob W, Giamporcaro Jane Ellen, Hornbeak Dana M, Katz L Jay, Navratil Tomas
AI Summary
iStent Infinite effectively and safely lowered eye pressure in patients with uncontrolled open-angle glaucoma, offering a new treatment option for challenging cases.
Abstract
Prcis: 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.
Purpose
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.
Design
Prospective, multicenter, single-arm, open-label clinical trial.
Methods
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.
Results
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.
Conclusions
iStent infinite stand-alone surgery achieved clinically significant IOP reduction and favorable safety in patients with OAG uncontrolled by prior therapy.
MeSH Terms
Shields Classification
Key Concepts4
The iStent Infinite Trabecular Micro-Bypass System, implanted as a stand-alone surgical procedure in patients with open angle glaucoma (OAG) uncontrolled by prior surgical or medical therapy, was effective in reducing mean diurnal intraocular pressure (MDIOP) with a favorable safety profile.
In a prospective, multicenter, single-arm, open-label clinical trial of 72 eyes of 72 patients with open angle glaucoma (OAG) uncontrolled by prior surgical or medical therapy, 76.1% of all enrolled patients met the responder endpoint of achieving ≥20% mean diurnal intraocular pressure (MDIOP) reduction from baseline at month 12 on the same or fewer intraocular pressure (IOP)-lowering medication classes after implantation of the iStent Infinite Trabecular Micro-Bypass System.
In a prospective, multicenter, single-arm, open-label clinical trial of 72 eyes of 72 patients with open angle glaucoma (OAG) uncontrolled by prior surgical or medical therapy, the iStent Infinite Trabecular Micro-Bypass System achieved a mean reduction (SE) in mean diurnal intraocular pressure (MDIOP) at month 12 of 5.9(0.6) mm Hg.
In a prospective, multicenter, single-arm, open-label clinical trial of 72 eyes of 72 patients with open angle glaucoma (OAG) uncontrolled by prior surgical or medical therapy, the iStent Infinite Trabecular Micro-Bypass System demonstrated favorable safety, with no explants, infection, or device-related interventions or hypotony reported.
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