ABSTRACT
INTRODUCTION: This study evaluated 10-year results of implanting one iStent trabecular micro-bypass stent during cataract surgery in eyes with open-angle glaucoma (OAG) or ocular hypertension. METHODS: This retrospective, non-randomized study examined 10-year outcomes of iStent trabecular micro-bypass stent implantation with cataract surgery by one surgeon in eyes with OAG [including primary OAG (POAG) and pseudoexfoliative glaucoma (PXG)] or ocular hypertension at a multi-specialty German ophthalmology center. Study visits were conducted preoperatively and at 2.5, 3, 5, and 10 years postoperatively; examinations included intraocular pressure (IOP), medications, corrected-distance visual acuity (CDVA), and adverse events. RESULTS: A total of 63 eyes of 45 patients with OAG (n = 60 eyes) or ocular hypertension (n = 3 eyes) and data through 10 years were analyzed. Mean preoperative IOP was 18.6 ± 4.4 mmHg on 1.83 ± 1.03 mean medications. At study visits through 10 years postoperative, mean IOP reduced by 12.9-19.0% (p < 0.005 at all points), and mean medication burden reduced by 37.8-51.4% (p ≤ 0.006 at all points). At 10 years postoperatively, 77.8% of eyes had IOP ≤ 18 mmHg and 47.6% had IOP ≤ 15 mmHg (vs. 50.8% and 25.4% preoperatively, respectively; p = 0.016). One-third (33.3%) of eyes were medication-free vs. 3.2% preoperatively (p < 0.001); 17.5% were on 2-5 medications (vs. 55.6% preoperatively, p = 0.005); and 93.7% of eyes were on the same or fewer medications vs. preoperative. Post-phacoemulsification CDVA improvement was maintained; no filtering surgeries were completed over 10-year follow-up. CONCLUSIONS: Significant and safe IOP and medication reductions were observed through 10 years after iStent implantation with cataract surgery in patients with OAG or ocular hypertension.
ABSTRACT
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.