Abstract
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 (R)). 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.