European Registry Collecting Data on Premature Infants Treated for Retinopathy of Prematurity Across Europe

What this Trial Is About

This research aims to collect comprehensive information on infants treated for retinopathy of prematurity ROP across multiple European countries. It is an observational registry study designed to gather data on the natural history of severe ROP, including variations in the diseases clinical features and progression, as well as treatment and follow-up patterns. The study is open-ended and includes infants regardless of the treatment method used at participating centers. The study involves enrolling preterm infants who require treatment for ROP according to national guidelines. No additional examinations or interventions are performed beyond routine clinical care. Data collected include baseline characteristics, treatment details at initial therapy and any re-treatments, and the stage of ROP through follow-up. Long-term ophthalmic and neurological development will also be tracked for up to 18 years. Participants clinical routine data are collected and documented electronically, focusing on treatment timing, disease progression, and outcomes. The primary outcomes include baseline data from birth to treatment, treatment parameters, and ROP stage through follow-up, typically spanning from birth to about one year. Secondary outcomes assess long-term eye and neurological health. This registry does not involve active treatment assignment and continues collecting data from infants treated at participating centers.

European Disease Registry on Retinopathy of Prematurity (ROP)