Second-Generation Trabecular Micro-Bypass (iStent inject) with Cataract Surgery in Eyes with Normal-Tension Glaucoma: One-Year Outcomes of a Multi-Centre Study

Abstract

Purpose: The efficacy and safety of the trabecular micro-bypass stents (iStent and iStent inject) have been well documented in various open-angle glaucoma subtypes. However, their outcomes remain understudied in normal-tension glaucoma (NTG). The present study aimed to assess the 1-year outcomes related to the implantation of two second-generation trabecular micro-bypass stents (iStent inject) concomitant with cataract surgery (CE-TMS), exclusively in eyes with NTG. Methods: This multi-center, consecutive case series included eyes with cataract and normal-tension glaucoma that underwent CE-TMS to reduce intraocular pressure or glaucoma medication use. The 12-month efficacy measures included change in average intraocular pressure (IOP) and medication burden. Safety included change in best-corrected visual acuity, cup-to-disc ratio, visual field mean-deviation and retinal nerve fiber layer thickness. Intra- or postoperative adverse events were noted. Results: A total of 62 eyes with mild-to-severe NTG and average preoperative IOP of 15.82 ± 2.94 mmHg on 1.50 ± 1.28 glaucoma medications were included. Postoperatively, IOP declined by 22% from 15.82 ± 2.94 mmHg to 12.32 ± 2.58 (p < 0.001), all eyes had IOP ≤ 18 mmHg (versus 74% preoperatively), and half had IOP ≤ 12 mmHg (versus 15% preoperatively). Medication burden decreased by 70% from 1.50 ± 1.28 to 0.45 ± 0.86 (p < 0.001), and 73% of the eyes were medication-free (versus 23% preoperatively). Safety was favorable, with no evidence of sight-threatening adverse events. Conclusion: Implantation of iStent inject (two second-generation trabecular micro-bypass stents) combined with cataract surgery is efficacious in reducing IOP and medication burden with a favorable safety profile in eyes with mild-to-severe NTG.