ABSTRACT
PURPOSE: This multicenter study evaluated 2-year effectiveness and safety following implantation of two second-generation trabecular micro-bypass stents (iStent inject ®) with phacoemulsification. MATERIALS AND METHODS: This was a retrospective study of iStent inject implantation with phacoemulsification by nine surgeons across Australia. Eyes had mild to advanced glaucoma (predominantly primary open-angle/POAG, appositional angle-closure/ACG, or normal-tension/NTG) or ocular hypertension (OHT), and cataract. Evaluations included intraocular pressure (IOP); medications; proportions of eyes with 0 or ≥2 medications, reduced/stable medications versus preoperative, and IOP ≤15 mmHg; visual acuity; cup-to-disc ratio (CDR); visual fields (VF); adverse events; and secondary surgery. RESULTS: A total of 340 eyes underwent surgery and had 24-month follow-up data. At 24 months, mean IOP decreased by 16% from 16.4±4.7 mmHg preoperatively to 13.7±3.1 mmHg (p<0.001), and 77% of eyes achieved IOP of ≤15 mmHg versus 49% preoperatively (p<0.001). Mean number of medications decreased by 67% to 0.49±0.95 versus 1.49±1.20 preoperatively (p<0.001), with 74% of eyes medication-free versus 25% preoperatively (p<0.001), and 14% of eyes on ≥2 medications versus 46% preoperatively (p<0.001). Medication burden was reduced or stable in 98% of eyes versus preoperative. Stratified analyses showed significant IOP and medication reductions across glaucoma subtypes (POAG, ACG, NTG, OHT): 13-22% for IOP (p<0.01 for all) and 62-100% for medication (p<0.001 for all). Favorable safety included few adverse events; stable CDR, VF, and visual acuity; and filtering surgery in only 8 eyes (2.4%) over 2 years. CONCLUSION: This 340-eye multicenter dataset provides robust evidence of the safety and efficacy of iStent inject implantation with phacoemulsification, with significant and sustained IOP and medication reductions through 2 years. Results were similarly favorable across glaucoma subtypes (including POAG, ACG, NTG, OHT) and were attained across various glaucoma severities, clinical sites, and surgeons, highlighting the real-world versatility and utility of this treatment modality.
ABSTRACT
PURPOSE: Simultaneous cataract and glaucoma surgery has traditionally been challenging for the anterior segment surgeon. The introduction of minimally invasive glaucoma surgery (MIGS) in conjunction with cataract surgery appears safe and effective in lowering intraocular pressure. Although a significant visual impact leading from the combined procedure is unexpected, we aim to describe the refractive outcomes in a cohort of patients undergoing simultaneous cataract removal and iStent inject and discuss the potential implications of combined surgery in patients with co-existent glaucoma. PATIENTS AND METHODS: This is a retrospective consecutive case series inclusive of patients undergoing combined femtosecond laser-assisted cataract surgery and the insertion of two trabecular micro-bypass stents (iStent inject). Visual acuity, refraction and astigmatic vector analysis were collated and analysed from the preoperative and 4 weeks postoperative visits. RESULTS: One hundred and six eyes of 89 patients from 2 surgeons were included in the original cohort. The mean absolute difference from target refraction was 0.36 ± 0.25D. 73.9% of eyes were within ± 0.5D of the refractive target and 98.9% of eyes were within ± 1.00D. 73.8% of eyes had 0.5D or less residual refractive astigmatism following the procedure. CONCLUSION: We present a novel cohort of glaucoma patients undergoing combined trabecular micro-bypass stents (iStent inject) and cataract surgery achieving excellent refractive outcomes. The results of this study indicate that this second-generation device is refractively neutral.
ABSTRACT
PURPOSE: To assess the utility and safety of implanting two second-generation trabecular micro-bypass stents following cataract surgery in eyes with mild to advanced glaucoma or ocular hypertension (OHT). PATIENTS AND METHODS: Retrospective study of iStent®inject trabecular micro-bypass implantation with cataract surgery by five surgeons at five sites in Australia. Eyes had mild to advanced glaucoma (predominantly primary open-angle, appositional angle-closure, or pseudoexfoliative glaucoma) or OHT and cataract requiring surgery. Effectiveness measures included intraocular pressure (IOP); medication burden; and proportions of eyes with no medications, ≥2 medications, stable or decreased medications vs preoperative, and IOP ≤18 mmHg. Safety measures included visual acuity, cup-to-disc ratio (CDR), visual field (VF), complications, adverse events, and secondary surgical interventions. Patients have been followed for 12 months, and follow-up is ongoing. RESULTS: Of the 290 total eyes that underwent surgery, 165 eyes had 12-month outcomes at the time of data collection and are included in this report. In these eyes, mean Month 12 IOP reduced by 23.2% from 18.27±5.41 mmHg preoperatively to 14.04±2.98 mmHg (P<0.001), with 95.8% of eyes achieving Month 12 IOP of ≤18 mmHg vs 60.6% preoperatively. Mean number of medications at 12 months decreased by 71.5%, 0.47±0.95 vs 1.65±1.28 preoperatively; 76.4% of eyes were on zero medications vs 17.6% preoperatively (P<0.001); 14.5% of eyes were on ≥2 medications vs 46.7% preoperatively (P<0.001); and 98.2% of eyes maintained or reduced medications vs their preoperative regimen. Favorable safety included no stent-related intraoperative complications; limited and transient postoperative adverse events; and stable CDR, VF, and visual acuity. Three eyes with more advanced disease underwent additional glaucoma surgeries. CONCLUSION: iStent inject implantation with cataract surgery significantly and safely reduced medications and IOP in eyes with various types and severities of glaucoma within a multicenter, multi-provider, real-life setting.