Validation Study of i-ROP DL, an Automated Screening Device to Detect More Than Mild Retinopathy of Prematurity (MTMROP)

Retinopathy of prematurity is a disease that develops when babies are born prematurely, before the retina has fully developed. It is a leading cause of childhood blindness worldwide, but blindness is usually avoidable with accurate diagnosis, and timely treatment of babies with treatment-requiring disease. The purpose of diagnostic eye exams therefore (sometimes referred to as "ROP screening" examinations by clinicians) is to identify severe disease that requires treatment, and administer treatment, to reduce the risk of blindness.

Each country has accepted criteria for which babies require eye examinations for ROP. In the United States, all babies born less than 31 weeks post-menstrual age (PMA) or under 1500 grams require diagnostic eye examinations starting at 31 weeks PMA or 4 weeks after birth, whichever is later. Exams are repeated at 1-2 week intervals depending on the level of disease identified on examination.

Diagnosis of ROP is made using either ophthalmoscopy (in person examination at the bedside) or using telemedicine with remote digital fundus imaging. Telemedicine has become an acceptable standard of care for ROP diagnostic examinations, and in most telemedicine workflows, exams are repeated weekly to minimize the risk of missing ROP. Whether exams occur in person or via telemedicine, the ophthalmologist is responsible for documenting the presence or absence of ROP using the International Classification of ROP (ICROP) guidelines, including documenting the presence and degree of zone, stage, and plus disease.

The zone, stage and plus disease classifications lead to overall disease severity categories, as defined by the Early Treatment for ROP (ETROP) study (see Table). The ETROP study determined that urgent treatment (within 48 hours) should occur when babies develop "type 1" ROP, but was not indicated for babies with type 2 ROP or less. Follow-up guidelines are determined by the responsible physician based on the level of disease, although in telemedicine these typically occur weekly.

ROP "screening" criteria are designed to be highly sensitive so that babies with any risk of developing type 1 ROP are captured in the screening population and receive diagnostic eye examinations. As a result, most babies who receive examinations do not have severe ROP on examination. ROP examinations (especially in person ophthalmoscopic examinations where scleral depression is utilized) are stressful to the neonates, and time consuming to the ophthalmologist, and thus the current system is inefficient and exposes neonates to added stress, which can have significant short and long-term consequences . The ideal solution would be to reduce the number of in person examinations a baby receives without missing any cases of type 1 ROP, and limit the number of diagnostic eye examinations an ophthalmologist needs to perform to those babies with more than mild ROP (type 2 or worse).