Outcomes of combined trabecular micro-bypass and phacoemulsification in a predominantly Hispanic patient population

PURPOSE: The purpose of this study was to evaluate intraocular pressure (IOP) and topical ocular hypotensive medication burden at 12 months postoperatively in a predominantly Hispanic patient population with primary open-angle glaucoma each implanted with one trabecular micro-bypass stent during cataract surgery. METHODS: This was a retrospective, consecutive case series. The main objective was to assess reduction of IOP and/or medication burden in all eyes at the 12-month postoperative exam. A secondary objective was to assess outcomes in 3 subgroups, distinguished preoperatively by IOP control and by medication burden (suboptimal or maximum therapy) and with different treatment goals. Group 1 had medication-controlled IOP and goal to reduce medications while maintaining IOP control (n=65); Group 2 had uncontrolled IOP on ≤2 medications and goal to reduce IOP and maintain/reduce medication burden (n=31); and Group 3 had uncontrolled IOP on ≥3 medications and goal to reduce IOP and avoid filtering surgery (n=38). Evaluations included IOP, medication use, cup-to-disc ratio, visual fields, complications, and interventions. One hundred subjects (134 eyes) have been followed for 12 months. RESULTS: Most patients (80%) were Hispanic and had moderate or severe glaucoma (87%). At 12 months, mean IOP reduced to 12.9 mmHg vs 16.5 mmHg preoperatively; 92% had an IOP ≤15 mmHg at 12 months (99% had ≤18 mmHg). Mean medication burden had decreased to 0.9 vs 2.3 preoperatively. At the 12-month time point, 94% of all eyes achieved their predefined treatment goal of reduced IOP and/or medications. Reductions in medication burden for Group 1, and in IOP for Groups 2 and 3, were highly statistically significant (P<0.001). Two eyes in Group 3 had filtering surgery; the remaining 95% avoided such treatment. No other complications were reported. CONCLUSION: This mainly Hispanic population with predominantly moderate or severe glaucoma had substantial reduction of IOP and medication and favorable safety for 12 months following stent implantation during cataract surgery, with treatment success achieved in all 3 subgroups. These data show this stent technology to be effective in Hispanic eyes with more advanced disease.