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

doi:10.5005/jp-journals-10078-1447

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

J Curr Glaucoma Pract. 2024 Jul-Sep;18(3):103-109. doi: 10.5005/jp-journals-10078-1447. Epub 2024 Oct 29.

Authors

Brandon Huynh¹, Colin Clement², Vuong Nguyen³, Stephen O'Hagan⁴, Frank Howes⁵, Peter Macken⁶, David Manning⁷, Ridia Lim², Jed Lusthaus⁸, Mitchell Lawlor⁹

Affiliations

¹ Department of Ophthalmology, Sydney Eye Hospital, Sydney, NSW, Australia.
² Glaucoma Unit, Sydney Eye Hospital, Sydney, NSW, Australia.
³ Department of Ophthalmology Faculty of Medicine and Health, Save Sight Institute, University of Sydney, Sydney, NSW, Australia.
⁴ Discipline of Ophthalmology, School of Medicine, James Cook University, Cairns Hospital, Queensland, Australia.
⁵ Discipline of Ophthalmology, Bond University, Queensland, Australia.
⁶ Discipline of Ophthalmology, University of Wollongong, Wollongong, NSW, Australia; Department of Ophthalmology, Bowral and District Hospital, Bowral, NSW, Australia.
⁷ Hunter Cataract and Eye Centre, Charlestown, NSW, Australia.
⁸ Glaucoma Unit, Sydney Eye Hospital, Sydney, NSW, Australia; Discipline of Ophthalmology, The University of Sydney, Sydney, NSW, Australia.
⁹ Department of Ophthalmology, Save Sight Institute, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia; Glaucoma Unit, Sydney Eye Hospital, Sydney, NSW, Australia.

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.

How to cite this article: Huynh B, Clement C, Nguyen V, et al. 12-month Safety and Efficacy Outcomes of a Standalone Trabecular Bypass Device. J Curr Glaucoma Pract 2024;18(3):103-109.

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