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

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.