SBIR-STTR Award

This SBIR is to develop a pediatric widefield fundus camera (WFC) for non-mydriatic examination of retinopathy of prematurity (ROP). In coordination with unique eye speculum based trans-pars planar illuminator, this pediatric WFC will be a low-cost and portable device with 1500 fundus view in single-shot images. It is known that ROP can affect periphery of the retina, and thus widefield fundus examination is essential for ROP screening, diagnosis and treatment management. However, it is technically difficult and financially expensive to construct WFCs, due to the complications of illumination and imaging mechanisms. We have recently employed trans- palpebral and trans-pars planar illumination to demonstrate widefield fundus photography (PCT/US2017/020449). The novel illumination approaches deliver illuminating light through pars plana (i.e., area outside of the pupil), freeing the whole pupil for image purpose only. Therefore, optical design of WFC can be significantly simplified. The trans-pars planar illumination provides one unique opportunity to develop pediatric WFC for affordable and non-mydriatic ROP screening. We have experimentally demonstrated the feasibility of widefield fundus photography with trans-palpebral illumination. However, image quality of trans-palpebral illumination is dependent on reliable localization of the pars plana. Because infants cannot provide voluntary cooperation, accurate localization of the pars plana is time-consuming and image quality is not well repeatable among different tests. To tackle the problem of pars planar localization, we propose here to develop an eye speculum based illuminator for accurate trans-pars planar illumination. The first aim of this project is to construct a pediatric WFC, with 150o fundus view and 20 pixels/degree resolution. An eye speculum based fiber bundle illuminator will be developed to enable easy and reliable trans-pars planar illumination. The second aim is functional validation of the pediatric WFC. We will conduct quantitative evaluation of field of view, spatial resolution, and image contrast of the pediatric WFC using a model eye first. For clinical validation, we will recruit 12 ROP infant subjects. Fundus images will be acquired using both prototype WFC and RetCam 3 at UIC Lions of Illinois Eye Research Institute. Success criterion of the Phase I study is to validate single-shot 150° fundus images with spatial resolution, image contrast and performance repeatability comparable to that of Retcam, and demonstrate the potential of using the prototype WFC for ROP screening. Following Phase II is to refine system design for a user-friendly pediatric WFC product, and develop algorithms for automated classification of ROP using the proposed pediatric WFC.

Public Health Relevance Statement:
Project Narrative This SBIR is to develop a pediatric widefield fundus camera (WFC) for retinopathy of prematurity (ROP) screening. In coordination with unique eye speculum based trans-para planar illuminator, this pediatric WFC will be a low-cost, portable and non-mydriatic device with 1500 fundus view in single-shot images.

Project Terms:
Adverse effects; Affect; Algorithms; Area; base; Blindness; Blood Vessels; Childhood; Classification; Clinical; Clinical Research; contrast imaging; cost; density; design; Development; Devices; Diagnosis; Ensure; Evaluation; Eye; Fiber; Foundations; Fundus; fundus imaging; Fundus photography; Illinois; Image; Individual; Infant; innovation; instrument; Light; Lighting; Modeling; Mydriasis; Newborn Infant; novel; Ophthalmologist; Ophthalmology; Optics; Panthera leo; Performance; Peripheral; Phase; phase 1 study; Pigments; portability; Premature Infant; prevent; prototype; Pupil; Quantitative Evaluations; recruit; Research Institute; Resolution; Retina; Retinopathy of Prematurity; rural underserved; screening; Small Business Innovation Research Grant; Solid; Speculums; success; System; Testing; Time; Tissues; user-friendly; Validation; Visual impairment; Work

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.

Public Health Relevance Statement:
Project Narrative This SBIR is to develop a 2200 pediatric camera (PedCam) for retinopathy of prematurity (ROP) screening. In coordination with unique trans-para planar illuminator, the 2200 PedCam will be a low-cost, portable and non- mydriatic device to foster clinical deployments of digital fundus photography for ROP management.

Project Terms:
Affect; Age; Area; Blindness; Childhood; Classification; Clinic; Clinical; comparative; Consumption; cost; design; Development; Devices; Diagnosis; digital; Evaluation; experience; Exposure to; Eye; Eye diseases; Fostering; Fundus; fundus imaging; Fundus photography; Image; imaging platform; Light Coagulation; Lighting; low income country; Morphologic artifacts; Mydriatics; Newborn Infant; Ophthalmic examination and evaluation; Ophthalmologist; Ophthalmoscopy; Optics; Outcome; Pain; Patients; Performance; Peripheral; Pharmacology; Phase; phase 2 study; portability; Premature Infant; Preparation; prevent; Price; Procedures; Process; prototype; Pupil; Reading; Resolution; Retina; Retinopathy of Prematurity; rural underserved; screening; Small Business Innovation Research Grant; Standardization; Structure; success; Time; Validation; Visible Radiation; Visual impairment