Objective: Diabetic retinopathy (DR) is a neurodegenerative disease characterized by the presence of microcirculatory lesions. Among them, microaneurysms (MAs) are the first observable hallmark of early ophthalmological changes. The present work aims at studying whether the quantification of MA, haemorrhages (Hmas) and hard exudates (HEs) in the central retinal field (CRF) could have a predictive value on DR severity. Research Design and Methods: Retinal lesions (MAs, Hmas and HEs) were quantified in the CRF of 160 retinographies from diabetic patients from the IOBA reading center, previously classified by two expert readers with the 3 fields-Joslin system. Samples included different disease severity levels and excluded proliferating forms: no DR (n=30), mild non-proliferative (n=30), moderate (n=50) and severe (n=50). Results: Quantification of MAs, Hmas, and HEs revealed an increase trend of these lesions as DR severity progresses. Differences between severity levels were statistically significant, suggesting that the analysis of the CRF provides valuable information on severity level and could be used as a valuable tool to assess DR grading in the clinical practice. Conclusions: Even though further validation is needed, the counting of microvascular lesions in the central retinal field can be proposed as a rapid screening system to classify DR patients with different stages of severity according to the international classification.

BCN Peptides sponsored this research in the framework of a collaborative agreement with IOBA

This study was funded by BCN Peptides

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Ethics Committee named 'Comite de Etica de la Investigacion con Medicamentos del Area de Salud Valladolid Este' gave ethical approval for this research project and accepted that the project was carried out by the principal investigator and her team in the East Valladolid Health Area-HCUV. Ethical Committee Members: President Dr. Jose Vicente Esteban Velasco (MD, Deputy Director) Vice-President Dr. Cristina Hernan Garcia (MD, Preventive Medicine and Public Health - HCUV) Technical Secretary Dr. Francisco Javier Alvarez Gonzalez (MD, Pharmacology, Faculty of Medicine, Valladolid) Board Members Dra. Marta Velasco Gonzalez (Clinical Pharmacologist) Dr. Vicente Molina Rodriguez (MD, Phsychiatrist) Mr Jose Maria Revuelta Bueno (Lawyer) Ms Julia Garcia Miguel (Lawyer, Senior Technician in Health Administration, data protection officer) Ms Mercedes Hernando Verdugo (Pharmacist from the HCUV Pharmacy) Ms Mercedes Fernandez de Castro (Nurse, HUCV Research Support Unit) Dr. Hortensia Marcos Sanchez (MD, Laboratory HCUV) Dr. Angel Luis Guerrero Peral (MD, Neurology HCUV) Dr. Enrique San Norberto Garcia (MD, Vascular Surgery HCUV) Ms Ana M. Ruiz San Pedro (Pharmacist, Primary Care - Pharmacy) Dr. M. Cristina Garcia-Loygorri Jordan de Urries (MD, Microbiology Hospital Medina del Campo) Dr. Rafael Lopez Castro (MD Oncology HUCV) Dr. Juan Bustamante Munguira (MD Heart Surgery HCUV)

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

The Color Fundus Photography images were provided by the Instituto de Oftalmobiologia Aplicada (IOBA) of the University of Valladolid (IOBA-UVA) reading centre (Valladolid, Spain) from their image data set. IOBA-UVA reading centre holds a CFP database, from the DR blindness prevention program of the Junta de Castilla y Leon (Regional Government), with images captured and read by certified personnel using the JVN system.