Retinopathy of prematurity (ROP) is a disease that affects premature infants. It is the leading cause of childhood blindness. Although effective treatments exist, many infants are still at-risk due to the small window of time for detection. The current standard of care consists of in-person, manual screening by a pediatric ophthalmologist. Unfortunately, the number of infants in need of screening far surpasses the availability of specifically trained ophthalmologists. Consequently, fewer than 30 percent of neonatal intensive care units (NICUs) worldwide have fully compliant ROP screening programs.
Telemedicine has been proposed as a possible solution to the screening deficit, but equipment and training costs present two major barriers to adoption. The current telemedicine standard is the RetCam, which is prohibitive due to high cost, complicated controls, and lack of any telemedicine pipeline. RetCam is not designed for NICU incubators, and its large and heavy form factor poses a risk of crushing infants if misused. Other imagers fail to address the two greatest barriers to telemedicine adoption: cost and ease of use.
In response, a team of researchers developed the Kaleyedos Imaging Device (KID). The KID streamlines the infant retinal imaging process, providing a low-cost, deskilled telemedicine solution for ROP. The hardware component is a compact, wireless device specifically designed to be maneuverable in an infant incubator. The device itself contains a high-resolution camera; a noncontact, wide-field optical system with a specialized noncontact lens; and a novel illumination schema that works with a software suite to allow the user to obtain high-quality retinal images at a much lower cost than currently available infant retinal imagers. Factoring in labor, production costs are less than $500 per unit, 10–20 times cheaper than production costs of competitors.
The proprietary software component consists of a cloud server and an image processing suite. Images taken by the device are automatically uploaded to a cloud server where the software processes them, stores them, and makes them remotely accessible for grading from anywhere in the world. The image processing suite uses computer vision concepts to aggregate images from a specialized optical system. The system increases image quality and retinal field of view without additional hardware costs.
The device has been validated on medically relevant phantoms. A pilot human study is under way at the Johns Hopkins Hospital.
The team will begin marketing in the United States where telemedicine provides an inexpensive and efficient solution for ROP screening. KID units are priced at $5,000 to undercut competition (priced at $30,000–$75,000) and to bypass administrative hospital purchasing boards, allowing them to market directly to end-user NICU clinicians and nurses through departmental purchasing channels. Another source of income will be software subscriptions, priced at $10,000 per hospital per year.
Globally, up to 40 percent of premature infants develop ROP and around 10 percent of premature infants become blind within the first month, while 490,000 infants are born blind each year. The solution will not only drastically reduce the downstream costs of screening, but also prevent childhood blindness worldwide.