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. However, even with advanced treatments available 400 to 600 of these infants be- come blind each year. Globally, there are more than 50,000 documented cases of preventable childhood blindness due to ROP. The World Health Organizataion has thus declared ROP a leading cause of vision im- pairment in children. These high numbers can be primarily attributed to inadequate screening of these infants due in part to the low numbers of pediatric-trained ophthalmologists and ROP diagnostic equipment in neonatal intensive care units (NICUs). Recent studies suggest that tele-screening with wide-angle retinal photography in combination with early treatment practices may be an economically feasible, cost-saving measure for im- proving the current standard of care for ROP, preventing many cases of needless blindness. In this application, RetiVue LLC proposes to develop the Atlas, a low cost (<$5,000 market cost), high resolu- tion, hand-held device capable of wide-field imaging of the retina for easily diagnosing and screening for ROP. Our unique design approach leverages novel retinal imaging technology developed at the University of Virginia that enables an extremely low cost device capable of capturing a 120? retinal field which may find use in tele- retinal ROP screening programs. Using this technology, we will first engineer a wide-angle objective lens module capable of providing a continuously illuminated 120? view of the infant retina. This lens module will be designed such that the contacting surface will be physically compatible with the unique anatomical structure of the infant eye and surrounding facial bone structure. An alpha-prototype will then be constructed which inte- grates the objective lens module with a common consumer digital camera with customized firmware for image capture. The Atlas prototype will emphasize a lightweight (<1.25lbs) design with a compact, hand-held form factor. Work completed during this Phase I application in addition to subsequent clinical testing will lay the technical foundation onto which the world's first simple-to-manufacture, affordable, highly portable, and easy-to-use ROP screening device can be commercialized. We hope that this highly disruptive device can help overcome the primary economic and technological access barriers to establishing successful ROP tele-screening pro- grams within NICUs in developed and developing countries alike.

Public Health Relevance

Retinopathy of Prematurity (ROP) is a potentially blinding eye disease that affects preterm babies with very low birth weight. Each year in the US, 28,000 babies are at-risk for developing ROP, with more than 500 babies becoming blind from this disease. Proper screening and early treatment of ROP is cost-effective and can greatly reduce vision loss due to ROP, but it is not readily available at many hospitals. At RetiVue LLC, we are de- signing the Atlas, an affordable, portable camera that can accurately detect ROP. We believe the Atlas will for the first time enable widespread telemedicine screening programs for this disease throughout the US and abroad, and thereby greatly reduce the risk and cost of unnecessary blindness in these infants.

National Institute of Health (NIH)
National Eye Institute (NEI)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1-SBIB-T (10))
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Wujek, Jerome R
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United States
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