Artificial intelligence-based prediction of diabetic retinopathy evolution (EviRed): protocol for a prospective cohort.

INTRODUCTION: An important obstacle in the fight against diabetic retinopathy (DR) is the use of a classification system based on old imaging techniques and insufficient data to accurately predict its evolution. New imaging techniques generate new valuable data, but we lack an adapted classification based on these data. The main objective of the Evaluation Intelligente de la Rétinopathie Diabétique, Intelligent evaluation of DR (EviRed) project is to develop and validate a system assisting the ophthalmologist in decision-making during DR follow-up by improving the prediction of its evolution. METHODS AND ANALYSIS: A cohort of up to 5000 patients with diabetes will be recruited from 18 diabetology departments and 14 ophthalmology departments, in public or private hospitals in France and followed for an average of 2 years. Each year, systemic health data as well as ophthalmological data will be collected. Both eyes will be imaged by using different imaging modalities including widefield photography, optical coherence tomography (OCT) and OCT-angiography. The EviRed cohort will be divided into two groups: one group will be randomly selected in each stratum during the inclusion period to be representative of the general diabetic population. Their data will be used for validating the algorithms (validation cohort). The data for the remaining patients (training cohort) will be used to train the algorithms. ETHICS AND DISSEMINATION: The study protocol was approved by the French South-West and Overseas Ethics Committee 4 on 28 August 2020 (CPP2020-07-060b/2020-A01725-34/20.06.16.41433). Prior to the start of the study, each patient will provide a written informed consent documenting his or her agreement to participate in the clinical trial. Results of this research will be disseminated in peer-reviewed publications and conference presentations. The database will also be available for further study or development that could benefit patients. TRIAL REGISTRATION NUMBER: NCT04624737.

Hybrid Fusion of High-Resolution and Ultra-Widefield OCTA Acquisitions for the Automatic Diagnosis of Diabetic Retinopathy.

Optical coherence tomography angiography (OCTA) can deliver enhanced diagnosis for diabetic retinopathy (DR). This study evaluated a deep learning (DL) algorithm for automatic DR severity assessment using high-resolution and ultra-widefield (UWF) OCTA. Diabetic patients were examined with 6×6 mm2 high-resolution OCTA and 15×15 mm2 UWF-OCTA using PLEX®Elite 9000. A novel DL algorithm was trained for automatic DR severity inference using both OCTA acquisitions. The algorithm employed a unique hybrid fusion framework, integrating structural and flow information from both acquisitions. It was trained on data from 875 eyes of 444 patients. Tested on 53 patients (97 eyes), the algorithm achieved a good area under the receiver operating characteristic curve (AUC) for detecting DR (0.8868), moderate non-proliferative DR (0.8276), severe non-proliferative DR (0.8376), and proliferative/treated DR (0.9070). These results significantly outperformed detection with the 6×6 mm2 (AUC = 0.8462, 0.7793, 0.7889, and 0.8104, respectively) or 15×15 mm2 (AUC = 0.8251, 0.7745, 0.7967, and 0.8786, respectively) acquisitions alone. Thus, combining high-resolution and UWF-OCTA acquisitions holds the potential for improved early and late-stage DR detection, offering a foundation for enhancing DR management and a clear path for future works involving expanded datasets and integrating additional imaging modalities.

Towards population-independent, multi-disease detection in fundus photographs.

Independent validation studies of automatic diabetic retinopathy screening systems have recently shown a drop of screening performance on external data. Beyond diabetic retinopathy, this study investigates the generalizability of deep learning (DL) algorithms for screening various ocular anomalies in fundus photographs, across heterogeneous populations and imaging protocols. The following datasets are considered: OPHDIAT (France, diabetic population), OphtaMaine (France, general population), RIADD (India, general population) and ODIR (China, general population). Two multi-disease DL algorithms were developed: a Single-Dataset (SD) network, trained on the largest dataset (OPHDIAT), and a Multiple-Dataset (MD) network, trained on multiple datasets simultaneously. To assess their generalizability, both algorithms were evaluated whenever training and test data originate from overlapping datasets or from disjoint datasets. The SD network achieved a mean per-disease area under the receiver operating characteristic curve (mAUC) of 0.9571 on OPHDIAT. However, it generalized poorly to the other three datasets (mAUC < 0.9). When all four datasets were involved in training, the MD network significantly outperformed the SD network (p = 0.0058), indicating improved generality. However, in leave-one-dataset-out experiments, performance of the MD network was significantly lower on populations unseen during training than on populations involved in training (p < 0.0001), indicating imperfect generalizability.

Automatic Screening for Ocular Anomalies Using Fundus Photographs.

SIGNIFICANCE: Screening for ocular anomalies using fundus photography is key to prevent vision impairment and blindness. With the growing and aging population, automated algorithms that can triage fundus photographs and provide instant referral decisions are relevant to scale-up screening and face the shortage of ophthalmic expertise. PURPOSE: This study aimed to develop a deep learning algorithm that detects any ocular anomaly in fundus photographs and to evaluate this algorithm for "normal versus anomalous" eye examination classification in the diabetic and general populations. METHODS: The deep learning algorithm was developed and evaluated in two populations: the diabetic and general populations. Our patient cohorts consist of 37,129 diabetic patients from the OPHDIAT diabetic retinopathy screening network in Paris, France, and 7356 general patients from the OphtaMaine private screening network, in Le Mans, France. Each data set was divided into a development subset and a test subset of more than 4000 examinations each. For ophthalmologist/algorithm comparison, a subset of 2014 examinations from the OphtaMaine test subset was labeled by a second ophthalmologist. First, the algorithm was trained on the OPHDIAT development subset. Then, it was fine-tuned on the OphtaMaine development subset. RESULTS: On the OPHDIAT test subset, the area under the receiver operating characteristic curve for normal versus anomalous classification was 0.9592. On the OphtaMaine test subset, the area under the receiver operating characteristic curve was 0.8347 before fine-tuning and 0.9108 after fine-tuning. On the ophthalmologist/algorithm comparison subset, the second ophthalmologist achieved a specificity of 0.8648 and a sensitivity of 0.6682. For the same specificity, the fine-tuned algorithm achieved a sensitivity of 0.8248. CONCLUSIONS: The proposed algorithm compares favorably with human performance for normal versus anomalous eye examination classification using fundus photography. Artificial intelligence, which previously targeted a few retinal pathologies, can be used to screen for ocular anomalies comprehensively.