Patients showed an appreciable degree of pupillary motion during measurement at all levels of illumination; the motion was largest under low mesopic illumination. The 2 pupils were rarely identical. Multiple-measurement binocular pupillometry is better than single monocular measurement to gain a precise description of pupil behavior before refractive surgery.
PurposeTo 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 methodsRetrospective 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.ResultsOf 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.ConclusioniStent 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.
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.
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