Surgical Outcomes of Combined 2nd-Generation Trabecular Microbypass (iStent Inject) and Cataract Surgery for the Treatment of Primary Open-Angle Glaucoma in the Saudi Population

INTRODUCTION: To investigate the 24-month efficacy and safety of iStent inject trabecular microbypass system implantation combined with phacoemulsification in subjects with primary open-angle glaucoma (POAG) and concomitant cataract. METHODS: This prospective, uncontrolled, interventional case series included 36 eyes (29 subjects) with POAG of mild to moderate severity and coexisting cataract that underwent combined phacoemulsification and implantation of a second-generation trabecular microbypass stent (iStent inject®). Main outcome measures involved mean intraocular pressure (IOP), number of antiglaucoma medications, and proportional analysis of eyes with IOP ≤ 18 mmHg or ≤ 15 mmHg, or with 0 or ≥ 2 glaucoma medications. Secondary outcome measures involved the cup-to-disc ratio, corrected distance visual acuity (CDVA), and adverse issues. RESULTS: In 36 eyes, the mean IOP at baseline was 18.28 ± 2.87 mmHg, which decreased to 14.24 ± 1.36 (22.1%) and 14.46 ± 1.56 mmHg (20.9%) at 18 and 24 months, respectively (p < 0.001). At the last follow-up, 100% of eyes had an IOP ≤ 18 mmHg (vs. 50% preoperatively), and 75.7% of eyes had an IOP ≤ 15 mmHg (vs. 16.7% preoperatively); 58.3% of eyes achieved ≥ 20% IOP reduction from preoperative status. At baseline, eyes were treated with a mean of 2.35 ± 1.18 medications, which was reduced to 0.80 ± 1.04 (66% reduction) and 0.69 ± 0.95 medications (70.6% reduction) at 18 and 24 months, respectively (p < 0.001). At the last follow-up, 54.1% of eyes were medication-free (vs. 0% preoperatively) and 24.3% of eyes were treated with ≥ 2 medications (vs. 64.9% preoperatively). This combined procedure demonstrated an excellent safety profile with no reported intraoperative complications or adverse events; CDVA was maintained throughout the entire follow-up period. CONCLUSIONS: This real-world series demonstrated that iStent inject device implantation at the time of phacoemulsification is a safe and effective method to decrease IOP and the necessity for antiglaucoma medications in patients with mild-to-moderate POAG and cataract; no associated vision-threatening complications were noted.