Assessing and monitoring abnormal retinal blood circulation for early detection of pre-structural damage and enhanced diabetic retinopathy staging using non-invasive, high-resolution biophotonic imaging technology

Biophotonic imaging technology offers a non-invasive solution for objectively and quantitatively staging diabetic retinopathy (DR) and detecting pre-DR before structural damage occurs. Integrating this technology into clinical practice enables more accurate staging, early risk management, and prediction of treatment outcomes, ultimately reducing DR-related structural damage. The platform featured a novel physics-based retinal oximetry algorithm, built on Saccadic-Phase Spatial Frequency Domain Imaging (SP-SFDI). This technology measured an oxygen saturation analogue (αSO₂) in tissue with high resolution, detecting oxygenation changes <3% using two snapshots capturing phase shifts in spatially modulated light. Its first application, BioxyDR™, focused on measuring αSO₂ in the superficial retinal vasculature for accurate DR staging and early detection. For clinical validation, the study included 63 DR patients, 60 diabetes mellitus (DM) patients without DR (DM no DR), and 18 controls (no DM, no known ocular diseases). Retinal venous αSO₂ significantly differed (p = 0.007) between controls and patient groups, including proliferative (PDR) and non-proliferative DR (NPDR). 100% of controls and DR patients were correctly classified per standard-of-care (SOC) criteria. Among DM no DR patients, 8 were classified as pre-DR, and 7 (87%) developed DR within 18 months. Notably, all patients classified as not pre-DR (100%) remained DR-free. Initial studies across various ocular diseases showed distinct classifications based on venous and arterial αSO₂. Taken together, these findings suggest that venous αSO₂ measured with SP-SFDI may serve as a biomarker for DR progression, with higher αSO₂ levels indicating greater disease severity. αSO₂ also shows promise as a metric for staging pre-DR.