Validation of an autonomous artificial intelligence-based diagnostic system for holistic maculopathy screening in a routine occupational health checkup context

Acord transformatiu CRUE-CSICPurpose: This study aims to evaluate the ability of an autonomous artificial intelligence (AI) system for detection of the most common central retinal pathologies in fundus photography. Methods: Retrospective diagnostic test evaluation on a raw dataset of 5918 images (2839 individuals) evaluated with non-mydriatic cameras during routine occupational health checkups. Three camera models were employed: Optomed Aurora (field of view - FOV 50º, 88% of the dataset), ZEISS VISUSCOUT 100 (FOV 40º, 9%), and Optomed SmartScope M5 (FOV 40º, 3%). Image acquisition took 2 min per patient. Ground truth for each image of the dataset was determined by 2 masked retina specialists, and disagreements were resolved by a 3rd retina specialist. The specific pathologies considered for evaluation were "diabetic retinopathy" (DR), "Age-related macular degeneration" (AMD), "glaucomatous optic neuropathy" (GON), and "Nevus." Images with maculopathy signs that did not match the described taxonomy were classified as "Other." Results: The combination of algorithms to detect any abnormalities had an area under the curve (AUC) of 0.963 with a sensitivity of 92.9% and a specificity of 86.8%. The algorithms individually obtained are as follows: AMD AUC 0.980 (sensitivity 93.8%; specificity 95.7%), DR AUC 0.950 (sensitivity 81.1%; specificity 94.8%), GON AUC 0.889 (sensitivity 53.6% specificity 95.7%), Nevus AUC 0.931 (sensitivity 86.7%; specificity 90.7%). Conclusion: Our holistic AI approach reaches high diagnostic accuracy at simultaneous detection of DR, AMD, and Nevus. The integration of pathology-specific algorithms permits higher sensitivities with minimal impact on its specificity. It also reduces the risk of missing incidental findings. Deep learning may facilitate wider screenings of eye diseases

Efficacy and safety of Intravitreal Aflibercept Vs Verteporfin Photodynamic Therapy in a Caucasian Population with Polypoidal Choroidal Vasculopathy: A Randomized Clinical Trial

Importance: Polypoidal choroidal vasculopathy (PCV) is far less common and studied in a Caucasian population than in an Asian population, and the optimal treatment approach remains to be confirmed. Methods: A 52-week, double-masked, sham-controlled, phase 4, investigator-initiated randomized clinical trial (RCT) in naive symptomatic Caucasian patients with PCV treated with aflibercept in a treat-and-extend regimen (T&E) (intravitreal aflibercept injection [IVAI] T&E). Patients were randomized at week 16 to receive IVAI T&E plus either sham photodynamic therapy (PDT) or standard fluence PDT with verteporfin. The main outcome measures were changes in best-corrected visual acuity (BCVA) from baseline to 52 weeks and polyp occlusion at week 52. Data are presented as median (interquartile range [IQR]) for BCVA, number of IVAI, and change in central retinal thickness (CRT). Results: Of the 50 patients included in the study, 48 patients completed the 52 weeks of follow-up. During this period, a significant median (IQR) BCVA gain of 6 [2-12] Early Treatment Diabetic Retinopathy Study letters was observed for all patients (p < 0.001), after 8 (7-9) injections, with a significant reduction of -93.0 [-154.0, -44.0] mu m in central macular thickness (p < 0.001). Using indocyanine green angiography, a complete occlusion of polypoidal lesions was documented in 72% of the cases. Still, no significant difference was detected between the sham PDT and the aflibercept PDT arms, at week 52, for BCVA change (6.5 [2-11] vs. 5 [2-13] letters (p = 0.98)), number of IVAIs (8.5 [7-9] vs. 8 [7-9] (p = 0.21)), change in CRT (-143 [-184; -47] vs. -89 [-123; -41.5] mu m [p = 0.23]), and rates of complete polyp occlusion: 77 versus 68% (p = 0.53) or presence of fluid: 68 versus 57% (p = 0.56). No serious ocular adverse events were registered in the 2 arms. Conclusions and Relevance: To our knowledge, this is the first RCT to compare aflibercept T&E monotherapy with aflibercept T&E plus verteporfin PDT in a Caucasian population with PCV. Aflibercept monotherapy in a T&E showed to be effective and safe with a significant median BCVA improvement of 6 letters and a complete occlusion of polypoidal lesions in near 3 quarters of the eyes, at 1 year. As only 22% of the eyes underwent PDT treatment, the benefit of combined treatment for PCV in Caucasian patients could not be definitively elucidated from this study