8 for the iStent inject Study Group* Purpose: Evaluate the safety and effectiveness of an ab interno implanted (iStent inject) Trabecular Micro-Bypass System (Glaukos Corporation, San Clemente, CA) in combination with cataract surgery in subjects with mild to moderate primary open-angle glaucoma (POAG). Design: Prospective, randomized, single-masked, concurrently controlled, multicenter clinical trial. Participants: Eyes with mild to moderate POAG and preoperative intraocular pressure (IOP) 24 mmHg on 1 to 3 medications, unmedicated diurnal IOP (DIOP) 21 to 36 mmHg, and cataract requiring surgery. Methods: After uncomplicated cataract surgery, eyes were randomized 3:1 intraoperatively to ab interno implantation of iStent inject (Model G2-M-IS; treatment group, n ¼ 387) or no stent implantation (control group, n ¼ 118). Subjects were followed through 2 years postoperatively. Annual washout of ocular hypotensive medication was performed. Main Outcome Measures: Effectiveness end points were !20% reduction from baseline in month 24 unmedicated DIOP and change in unmedicated month 24 DIOP from baseline. Safety measures included best spectacle-corrected visual acuity (BSCVA), slit-lamp and fundus examinations, gonioscopy, pachymetry, specular microscopy, visual fields, complications, and adverse events. Results: The groups were well balanced preoperatively, including medicated IOP (17.5 mmHg in both groups) and unmedicated DIOP (24.8AE3.3 mmHg vs. 24.5AE3.1 mmHg in the treatment and control groups, respectively, P ¼ 0.33). At 24 months, 75.8% of treatment eyes versus 61.9% of control eyes experienced !20% reduction from baseline in unmedicated DIOP (P ¼ 0.005), and mean reduction in unmedicated DIOP from baseline was greater in treatment eyes (7.0AE4.0 mmHg) than in control eyes (5.4AE3.7 mmHg; P < 0.001). Of the responders, 84% of treatment eyes and 67% of control eyes were not receiving ocular hypotensive medication at 23 months. Furthermore, 63.2% of treatment eyes versus 50.0% of control eyes had month 24 medication-free DIOP 18 mmHg (difference 13.2%; 95% confidence interval, 2.9e23.4). The overall safety profile of the treatment group was favorable and similar to that in the control group throughout the 2-year follow-up. Conclusions: Clinically and statistically greater reductions in IOP without medication were achieved after iStent inject implantation with cataract surgery versus cataract surgery alone, with excellent safety through 2 years.

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IMPORTANCE Diabetic retinopathy (DR) is a leading cause of blindness in adults worldwide. Early detection and intervention can prevent blindness; however, many patients do not receive their recommended annual diabetic eye examinations, primarily owing to limited access. OBJECTIVETo evaluate the safety and accuracy of an artificial intelligence (AI) system (the EyeArt Automated DR Detection System, version 2.1.0) in detecting both more-than-mild diabetic retinopathy (mtmDR) and vision-threatening diabetic retinopathy (vtDR). DESIGN, SETTING, AND PARTICIPANTSA prospective multicenter cross-sectional diagnostic study was preregistered (NCT03112005) and conducted from April 17, 2017, to May 30, 2018. A total of 942 individuals aged 18 years or older who had diabetes gave consent to participate at 15 primary care and eye care facilities. Data analysis was performed from February 14 to July 10, 2019. INTERVENTIONS Retinal imaging for the autonomous AI system and Early Treatment DiabeticRetinopathy Study (ETDRS) reference standard determination. MAIN OUTCOMES AND MEASURESPrimary outcome measures included the sensitivity and specificity of the AI system in identifying participants' eyes with mtmDR and/or vtDR by 2-field undilated fundus photography vs a rigorous clinical reference standard comprising reading center grading of 4 wide-field dilated images using the ETDRS severity scale. Secondary outcome measures included the evaluation of imageability, dilated-if-needed analysis, enrichment correction analysis, worst-case imputation, and safety outcomes. RESULTSOf 942 consenting individuals, 893 patients (1786 eyes) met the inclusion criteria and completed the study protocol. The population included 449 men (50.3%). Mean (SD) participant age was 53.9 (15.2) years (median, 56; range, 18-88 years), 655 were White (73.3%), and 206 had type 1 diabetes (23.1%). Sensitivity and specificity of the AI system were high in detecting mtmDR