Effectiveness and Safety of iStent Infinite Trabecular Micro-Bypass for Uncontrolled Glaucoma.

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.

• Authors: Steven R Sarkisian Jr, Davinder S Grover, Mark J Gallardo, Jacob W Brubaker, Jane Ellen Giamporcaro, Dana M Hornbeak, L Jay Katz, Tomas Navratil, iStent infinite Study Group
• Journal: Journal of glaucoma (J Glaucoma) Vol. 32 Issue 1 Pg. 9-18 (01 01 2023) ISSN: 1536-481X [Electronic] United States
• PMID: 36260288 (Publication Type: Multicenter Study, Journal Article)
• Copyright: Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.

Topics

• Humans
• Aged
• Glaucoma, Open-Angle (diagnosis, surgery, drug therapy)
• Intraocular Pressure
• Prospective Studies
• Glaucoma
• Trabecular Meshwork (surgery)
• Ocular Hypotension
• Stents