European Disease Registry on Retinopathy of Prematurity (ROP) (EU-ROP)

University Medicine Greifswald

Status: Enrolling

Conditions: Retinopathy of Prematurity

Treatments: Other: Registry of preterm born infants with treatment-requiring ROP

Study type: Observational

Funder types: Other

Identifiers

NCT04939571

EU-ROP

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• ROP requiring treatment according to the respective national ROP screening and treatment guidelines

Exclusion criteria

• Denial or absence of consent for documentation and electronic storage of personal data by parents or legal guardians

Trial design

3,000 participants in 1 patient group

Preterm born infants treated for ROP

Treatment:

Other: Registry of preterm born infants with treatment-requiring ROP