Long-term effectiveness and safety of trabecular microbypass stent implantation with cataract surgery in patients with glaucoma or ocular hypertension: Five-year outcomes

Purpose To assess 5-year outcomes after implantation of 1 trabecular microbypass stent during cataract surgery in eyes with open-angle glaucoma (OAG) or ocular hypertension. Setting Private ophthalmology clinic (AaM Augenklinik am Marienplatz, Munich, Germany). Design Prospective nonrandomized consecutive case series. Methods One trabecular microbypass stent was implanted after phacoemulsification cataract surgery by one surgeon over 4 years. Evaluations included intraocular pressure (IOP), medications, corrected distance visual acuity, cup-to-disc ratio, complications, and adverse events. Results This case series included 65 eyes of 43 patients with OAG (including primary, n = 39; pseudoexfoliative, n = 14; secondary uveitic, n = 1; posttraumatic, n = 1) or ocular hypertension (n = 10). Thirty-eight percent of eyes had previous trabeculectomy and/or glaucoma laser procedures, and 68% were on 2 or more preoperative medications. Twenty-six eyes completed follow-up through 5 years, and follow-up is ongoing. Among eyes without additional glaucoma surgery, the mean year 5 IOP decreased by 38% to 14.7 mm Hg ± 3.0 (SD) versus 23.7 ± 7.4 mm Hg preoperatively; 92% of eyes had a mean year 5 IOP of 18 mm Hg or lower and 65% had an IOP of 15 mm Hg or lower. Medications were reduced by 75% to 0.5 ± 0.9 medications versus 2.0 ± 1.0 preoperatively, with 4% of eyes on 3 to 4 medications versus 28% preoperatively, and 69% medication-free versus 5% preoperatively. The mean IOP at all postoperative visits was 16.0 mm Hg or lower and the mean medication number was 0.5 or less. Safety was favorable throughout the follow-up. Conclusions In a real-life cohort of eyes with OAG or ocular hypertension, substantial, durable, and safe IOP and medication reductions were achieved through 5 years after trabecular microbypass stent implantation with cataract surgery.