Randomized Evaluation of the Trabecular Micro-Bypass Stent with Phacoemulsification in Patients with Glaucoma and Cataract

Objective: To assess the safety and efficacy of the iStent trabecular micro-bypass stent (Glaukos Corporation, Laguna Hills, CA) in combination with cataract surgery in subjects with mild to moderate open-angle glaucoma. Design: Prospective, randomized, open-label, controlled, multicenter clinical trial. Participants: A total of 240 eyes with mild to moderate open-angle glaucoma with intraocular pressure (IOP) <= 24 mmHg controlled on 1 to 3 medications were randomized to undergo cataract surgery with iStent implantation (treatment group) or cataract surgery only (control). Fifty additional subjects were enrolled to undergo cataract surgery with iStent implantation under protocol expansion. Data in this report are based on the first 240 eyes enrolled. Intervention: Implantation of the iStent trabecular micro-bypass stent in conjunction with cataract surgery or cataract surgery only. Main Outcome Measures: The primary efficacy measure was unmedicated IOP <= 21 mmHg at 1 year. A secondary measure was unmedicated IOP reduction >= 20% at 1 year. Safety measures included best-corrected visual acuity (BCVA), slit-lamp observations, complications, and adverse events. Results: The study met the primary outcome, with 72% of treatment eyes versus 50% of control eyes achieving the criterion (P < 0.001). At 1 year, IOP in both treatment groups was statistically significantly lower from baseline values. Sixty-six percent of treatment eyes versus 48% of control eyes achieved >= 20% IOP reduction without medication (P = 0.003). The overall incidence of adverse events was similar between groups with no unanticipated adverse device effects. Conclusions: Pressure reduction on fewer medications was clinically and statistically significantly better 1 year after stent plus cataract surgery versus cataract surgery alone, with an overall safety profile similar to that of cataract surgery alone.