Three-Year Efficacy and Safety Outcomes of the Second-Generation Trabecular Micro-Bypass Stents in Conjunction with Cataract Surgery in Ocular Hypertension and Open-Angle Glaucoma

Abstract

Purpose: To evaluate the efficacy and safety of the iStent Inject in conjunction with phacoemulsification in patients with open-angle glaucoma. Design: Prospective, non-randomized, single-center, consecutive case series Participants: Patients with primary and secondary open angle glaucoma undergoing cataract surgery and iStent Inject Main outcomes: The primary outcome of efficacy is postoperative reduction in mean Intraocular Pressure (IOP) and number of anti-glaucomatous drop classes. A primary endpoint is the achievement of =20% IOP reduction from baseline. Secondary outcome measures include visual acuity, visual field parameters, cup-to-disk ratio, and average retinal nerve fiber layer thickness. Results: 150 eyes were included with a mean follow-up of 2.28 years (standard deviation 1.18). IOP significantly decreased at nearly all timepoints and remains significantly reduced from baseline at 36 months. IOP reduction is modest and ranges between 5.6 to 11.7 %, with IOP being stably maintained lower than baseline throughout the observation period. IOP reduction is greatest in the mild glaucoma group. The primary endpoint of an over 20% IOP reduction being achieved in overall 32% of eyes. The burden of glaucoma drops was significantly reduced by 13% at 12 months post-op (p<0.005). There was no statistically significant change in visual field parameters, although they improved after cataract surgery. The rate of additional glaucoma interventions needed were very low at <1%. Conclusion: The combined cataract surgery and iStent Inject procedure is safe and effective at long-term with a low rate of serious complications. It offers good visual outcomes and reasonable glaucoma control long-term.