European Disease Registry on Retinopathy of Prematurity (ROP)
University Medicine Greifswald
3,000 participants
Aug 6, 2021
OBSERVATIONAL
Conditions
Summary
The EU-ROP registry is a European wide multicenter non-interventional observational registry study intended to run open-ended in as many countries as possible including infants treated for retinopathy of prematurity irrespective of the used treatment modality. The registry is strictly observational; only clinical routine data is collected, no study-specific examinations or interventions are to be performed. The aim of the EU-ROP registry is to collect information on as many patients as possible treated for ROP in Europe. Both the number of study centers as well as the number of patients to be included into the registry are not limited. The primary objective is to describe the typical clinical features of infants with severe ROP, variations in phenotype, and the clinical progression of the disease over time (natural history) in different European countries as well as to study treatment patterns, follow-up patterns, as well as long-term outcomes.
Eligibility
Inclusion Criteria1
- ROP requiring treatment according to the respective national ROP screening and treatment guidelines
Exclusion Criteria1
- Denial or absence of consent for documentation and electronic storage of personal data by parents or legal guardians
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Interventions
All prematurely born infants who develop treatment requiring ROP and are treated (independent of the kind of treatment modality) at a center that participates in the registry are eligible for database entry.
Locations(59)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04939571