A Low-Cost, Ultra-Widefield, Nonmydriatic Retinal Imager for Pediatric Eye Care and ROP Screening

About This Grant

Project summary Biolight Engineering LLC, in collaboration with the University of Illinois Chicago (UIC), the University of Chicago and Children’s Hospital Los Angeles, proposes to commercialize an ultra-widefield pediatric fundus camera (PedCam) for nonmydriatic imaging of retinopathy of prematurity (ROP) and other pediatric retinal diseases. Premature infants, comprising approximately 10% of newborns, are at risk for ROP, a leading cause of visual impairment and childhood blindness. Because ROP and related diseases often involve the peripheral retina, widefield fundus imaging is essential for diagnosis and management. However, existing pediatric fundus cameras suffer from significant limitations, including restricted field of view (≤130°), high cost (>$70,000), the need for pharmacologic pupil dilation, and poor adaptability to variable ocular anatomy in newborns. These barriers hinder access to timely eye care, especially in underserved and resource-limited regions. To address these challenges, we have developed PedCam, a novel imaging platform that employs patented trans-pars-planar illumination to enable low-cost, ultra-widefield (200°), nonmydriatic retinal imaging. Our preliminary studies have demonstrated feasibility using both handheld and smartphone-based PedCam prototypes, achieving full retinal coverage with high image fidelity. In this Direct-to-Phase II SBIR project, we aim to (1) finalize and fabricate five minimal viable product (MVP) PedCam systems with integrated pupil-matching control, adjustable illumination, autofocusing, and HDR imaging; (2) validate clinical performance at UIC, the University of Chicago, and Children’s Hospital Los Angeles, collecting over 360 sets of images from more than 180 patients to compare PedCam with RetCam and traditional indirect ophthalmoscopy; and (3) complete safety testing and regulatory documentation necessary for FDA 510(k) submission. In parallel, PedCam images will be evaluated for use in deep learning classification of ROP severity and plus disease, supporting future telemedicine deployment. The project’s success criterion is submission of the 510(k) application by the project’s conclusion. PedCam’s low-cost (<$25,000), nonmydriatic, ultra-widefield design is uniquely positioned to reduce disparities in pediatric eye care by enabling point-of-care imaging and remote screening of premature infants at risk for blindness.