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VOLUME 18 , ISSUE 3 ( July-September, 2024 ) > List of Articles

Original Article

12-month Safety and Efficacy Outcomes of a Standalone Trabecular Bypass Device

Brandon Huynh, Colin Clement, Vuong Nguyen, Stephen O Hagan, Frank Howes, Peter Macken, David Manning, Ridia Lim, Jed Lusthaus, Mitchell Lawlor

Keywords : Glaucoma, iStent inject, Minimally invasive glaucoma surgery, Real world data

Citation Information : Huynh B, Clement C, Nguyen V, O Hagan S, Howes F, Macken P, Manning D, Lim R, Lusthaus J, Lawlor M. 12-month Safety and Efficacy Outcomes of a Standalone Trabecular Bypass Device. J Curr Glaucoma Pract 2024; 18 (3):103-109.

DOI: 10.5005/jp-journals-10078-1447

License: CC BY-NC 4.0

Published Online: 29-10-2024

Copyright Statement:  Copyright © 2024; The Author(s).


Abstract

Purpose: To analyze the outcomes of the iStent inject in a real-world clinical setting as a standalone procedure to lower intraocular pressure (IOP) in open-angle glaucoma. Materials and methods: Patients with open-angle glaucoma having undergone iStent inject insertion without concurrent cataract extraction were included in this multicenter observational real-world study in Australia. Patient data was entered into the Fight Glaucoma Blindness! Registry. Assessments through 12 months included glaucoma subtype, IOP, medications, best-corrected visual acuity (BCVA), secondary surgical procedures, and adverse events. Kaplan–Meier survival curves for outcomes were reported according to the World Glaucoma Association (WGA). Results: Sixty-one eyes from 44 patients with a mean age of 76 ± 11.4 underwent standalone iStent inject implantation. The mean ± SD preoperative IOP was 17.5 ± 7.5 mm Hg, and the mean preoperative number of topical medications was 2.5 ± 1.5. At 12 months postoperatively, there was no statistically significant IOP reduction, while the number of glaucoma medications used was reduced to 1.4 ± 1.5 (p < 0.001). Fourteen point one percent of eyes required a secondary pressure-lowering procedure within the 12-month follow-up window. Conclusion: This assessment of standalone iStent inject implantation did not show any significant reduction in IOP, but there was a significant decrease in medication use in the real-world clinical setting. The procedure is safe with minimal adverse outcomes; however, a subset of patients required secondary procedures within 12 months of follow-up.

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