Research Project
9048502
? DESCRIPTION (provided by applicant): Retinopathy of prematurity (ROP) is a treatable eye disease which affects the vision of neonatal infants with a birth weight of <1500g or gestational age of <30 weeks. There are 28,000 infants born each year in the US at risk for developing ROP. Globally, the World Health Organization has declared ROP a leading cause of vision impairment in children, with more than 50,000 babies suffering blindness each year due to this disease. Inad- equate screening of these infants results from the low numbers of pediatric-trained ophthalmologists and ROP diagnostic equipment in neonatal intensive care units (NICUs). Remote digital fundus imaging (RDFI-TM) has, per the American Academy of Pediatrics, high potential for telemedicine based diagnosis and management of ROP. This can alleviate the burden of repeat on-site examina- tions and ensure all infants receive timely screening. However, current technology unfortunately lacks the di- agnostic sensitivity to replace manual physician exam. To overcome this hurdle RetiVue L.L.C. has developed an early prototype of the RetiVue WF, an affordable hand-held imager that can image the entire peripheral retina without the need to reposition the hand-piece, as now required with current devices. Our imager will provide the highest resolution, highest image quality, and widest peripheral field of view of any portable device, allowing it to finally replace the need for direct physician exam. Our technology will also enable for the first time portable wide-field retinal imaging on older children and adult patients. Phase II efforts will be focused on 1) redesigning our interchangeable imaging module to decrease fogging, enhance sterilization, and improve field of view, 2) refining our patented multi-beam optical design to allow im- proved imaging with decreased lens haze, 3) developing alignment and autofocus assist capabilities to im- prove ease of use and 4) validating in clinical trials that our device has improved sensitivity and specificity for detecting ROP with respect to both existing devices and manual physician exam. Work completed during this Phase II application will lay the technical foundation on which we can commercial- ize the world's first simple-to-manufacture, affordable, highly portable, and easy-to-use ROP screening device. We hope that this highly disruptive device can help overcome the primary economic and technological access barriers to establishing successful ROP tele-screening programs within NICUs in developed and developing countries alike.
