A portable ultra-widefield fundus camera for nonmydriatic examination of retinopathy of prematurity

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Title: A portable ultra-widefield fundus camera for nonmydriatic examination of retinopathy of prematurity Summary: Prompt screening is an essential step to prevent visual impairment and blindness due to retinopathy of prematurity (ROP). It is known that widefield fundus examination is essential for ROP screening, diagnosis and treatment evaluation. However, existing pediatric fundus cameras have three major limits: limited field of view (FOV), high cost, and mydriatic imaging. This SBIR is to develop a pediatric camera (PedCam) which is an ultra-widefield (220o), low-cost ($25K), and non-mydriatic device to overcome all three limits of existing fundus cameras. In Phase I, we have constructed a lab prototype for proof-of-concept validation, and demonstrated the feasibility of using trans-pars-planar illumination for ultra-widefield fundus photography. By freeing the whole available pupil for imaging purpose only, the trans-pars-planar illumination significantly simplifies optical design of the PedCam. During the Phase II, we propose to optimize the optical design, standardize the fabrication process of key components, develop an easy-to-use imaging platform, and validate the PedCam for ROP screening. The first aim is prototype development of a 220° PedCam. Key specifications of the proposed device are: 220° FOV in a single-shot image; 20 µm resolution for central retina; and 40 µm for peripheral retina. In coordination with a near infrared guidance to minimize the visible light exposure to the retina, a three-channel illuminator will allow easy identification of the pars plana to enable high illumination efficiency with optimal image quality. The second aim is clinical validation of the 220° PedCam for ROP screening. For quantitative comparison, fundus images will be acquired using both the prototype PedCam and a clinical RetCam3 at UIC Retina Clinic. Binocular indirect ophthalmoscopy (BIO) will be used for standard ROP examination. Success criterion of the Phase II study is to verify that the non-mydriatic PedCam can provide performance superior to that of the mydriatic Retcam; and to demonstrate the potential of using the 220° PedCam for comprehensive pediatric fundus examination up to the ora serrata, which is not currently possible with the 130° Retcam. By the end of the phase II, technical specification of the 220o PedCam will be finalized for the 510(k) preparation required for FDA clearance.