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OBJECTIVE: To validate a vascular severity score as an appropriate output for artificial intelligence (AI) Software as a Medical Device (SaMD) for retinopathy of prematurity (ROP) through comparison with ordinal disease severity labels for stage and plus disease assigned by the International Classification of ROP, 3rd edition (ICROP3) committee. DESIGN: Validation study of an AI-based ROP vascular severity score SUBJECTS, PARTICIPANTS, AND/OR CONTROLS: 34 ROP experts from the ICROP3 committee. METHODS: Two separate datasets of 30 fundus photographs each for stage (0–5) and plus disease (plus, pre-plus, neither) were labeled by members of the ICROP3 committee using an open-source platform. Averaging these results produced a continuous label for plus (1–9) and stage (1–3) for each image. Experts were also asked to compare each image to each other in terms of relative severity for plus disease. Each image was also labelled with a vascular severity score from the Imaging and Informatics in ROP deep learning (i-ROP DL) system, which was compared with each grader’s diagnostic labels for correlation, as well as the ophthalmoscopic diagnosis of stage. MAIN OUTCOME MEASURES: Weighted kappa and Pearson correlation coefficients (CC) were calculated between each pair of grader classification labels for stage and plus disease. The Elo algorithm was also used to convert pairwise comparisons for each expert into an ordered set of images from least to most severe. RESULTS: The mean weighted kappa and CC for all inter-observer pairs for plus disease image comparison was 0.67 and 0.88 respectively. The vascular severity score was found to be highly correlated with both the average plus disease classification (CC = 0.90, p < 0.001) and the ophthalmoscopic diagnosis of stage (p < 0.001 by ANOVA) among all experts. CONCLUSIONS: The ROP vascular severity score correlates well with the ICROP committee member’s labels for plus disease and stage, which had significant inter-grader variability. Generation of a consensus for a validated scoring system for ROP SaMD can facilitate global innovation and regulatory authorization of these technologies.

PURPOSE: Aggressive posterior retinopathy of prematurity (AP-ROP) is a vision-threatening disease with a significant rate of progression to retinal detachment. The purpose of this study was to quantitatively characterize AP-ROP by demographics, rate of disease progression, and a deep learning based vascular severity score. DESIGN: Retrospective analysis SUBJECTS: The Imaging and Informatics in ROP (i-ROP) cohort from 8 North American centers, consisting of 947 total patients and 5945 clinical eye exams with fundus images, was used. Pre-treatment eyes were categorized by disease severity: None, Mild, Type 2 or Pre-Plus, Treatment-Requiring (TR) without AP-ROP, TR with AP-ROP. Analyses compared TR with AP-ROP to TR without AP-ROP to investigate differences between AP-ROP and other TR disease. METHODS: A reference standard diagnosis was generated for each eye exam using previously-published methods combining three independent image-based and one ophthalmoscopic gradings. All fundus images were analyzed using a previously-published deep learning system (i-ROP DL) and assigned a score from 1-9. Demographic data, systemic comorbidities, and post-menstrual age were evaluated for each category. MAIN OUTCOME MEASURES: Birth weight, gestational age, post-menstrual age, vascular severity score RESULTS: Infants who developed AP-ROP were more premature by birth weight (617 g vs 679 g, p=0.01) and gestational age (24.3 weeks vs 25.0 weeks, p

To determine the feasibility and safety of bilateral simultaneous vitreoretinal surgery in pediatric patients.International, multicenter, interventional, retrospective case series.Patients 17 years of age or younger from 24 centers worldwide who underwent immediate sequential bilateral vitreoretinal surgery (ISBVS)-defined as vitrectomy, scleral buckle, or lensectomy using the vitreous cutter-performed in both eyes sequentially during the same anesthesia session.Clinical history, surgical details and indications, time under anesthesia, and intraoperative and postoperative ophthalmic and systemic adverse events were reviewed.Ocular and systemic adverse events.A total of 344 surgeries from 172 ISBVS procedures in 167 patients were included in the study. The mean age of the cohort was 1.3±2.6 years. Nonexclusive indications for ISBVS were rapidly progressive disease (74.6%), systemic morbidity placing the child at high anesthesia risk (76.0%), and residence remote from surgery location (30.2%). The most common diagnoses were retinopathy of prematurity (ROP; 72.7% [P0.01]; stage 3, 4.8%; stage 4A, 44.4%; stage 4B, 22.4%; stage 5, 26.4%), familial exudative vitreoretinopathy (7.0%), abusive head trauma (4.1%), persistent fetal vasculature (3.5%), congenital cataract (1.7%), posterior capsular opacification (1.7%), rhegmatogenous retinal detachment (1.7%), congenital X-linked retinoschisis (1.2%), Norrie disease (2.3%), and viral retinitis (1.2%). Mean surgical time was 143±59 minutes for both eyes. Higher ROP stage correlated with longer surgical time (P = 0.02). There were no reported intraoperative ocular complications. During the immediate postoperative period, 2 eyes from different patients demonstrated unilateral vitreous hemorrhage (0.6%). No cases of endophthalmitis, choroidal hemorrhage, or hypotony occurred. Mean total anesthesia time was 203±87 minutes. There were no cases of anesthesia-related death, malignant hyperthermia, anaphylaxis, or cardiac event. There was 1 case of reintubation (0.6%) and 1 case of prolonged oxygen desaturation (0.6%). Mean follow-up after surgery was 103 weeks, and anatomic success and globe salvage rates were 89.8% and 98.0%, respectively.This study found ISBVS to be a feasible and safe treatment paradigm for pediatric patients with bilateral vitreoretinal pathologic features when repeated general anesthesia is undesirable or impractical.

Tele-education systems are increasingly being utilized in medical education worldwide. Due to limited human resources in healthcare in low and middle-income countries, developing online systems that are accessible to medical trainees in underserved areas potentially represents a highly efficient and effective method of improving the quantity and quality of the health care workforce. We developed, implemented, and evaluated an interactive web-based tele-education system (based on internationally accepted, image-based guidelines) for the diagnosis of retinopathy of prematurity among ophthalmologists-in-training in Brazil, Mexico, and the Philippines. We demonstrate that participation in this tele-education program improved diagnostic accuracy and reliability, and was preferred to standard pedagogical methods. This system may be employed not only in training, but also in international certification programs, and the process may be generalizable to other image-based specialties, such as dermatology and radiology.