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.
Study Type
OBSERVATIONAL
Enrollment
3,000
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.
University Eye Hospital Salzburg
Salzburg, Austria
RECRUITINGUniversity Hospital Saint George
Plovdiv, Bulgaria
RECRUITINGAcibadem City Clinic Tokuda Hospital
Sofia, Bulgaria
RECRUITINGUniversity Eye Hospital Alexandrovska
Sofia, Bulgaria
Baseline data of preterm born infants who develop treatment-requiring retinopathy of prematurity
Birth weight, gestational age, weight at treatment, comorbidities (e.g. sepsis, necrotizing enterocolitis)
Time frame: Birth to treatment of ROP, an average of 12 weeks
Treatment parameters at initial treatment
Type of treatment
Time frame: An average of 12 weeks postnatal age
Treatment parameters at re-treatment
Type of treatment
Time frame: Through study completion, an average of 20 to 30 weeks postnatal age
ROP stage
Stage of ROP at treatment and during follow-up
Time frame: Through follow-up after treatment, an average of 1 year postnatal age
Long-term ophthalmic development
Ophthalmic development (e.g. orthoptic status, visual acuity)
Time frame: Up to 18 years
Long-term neurologic development
Neurological developmental (e.g. assessed by psychometric assessments)
Time frame: Up to 18 years
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University Eye Hospital Tartu
Tartu, Estonia
RECRUITINGHospital Rothschild
Paris, France
RECRUITINGUniversity Eye Hospital
Aachen, Germany
RECRUITINGUniversity Eye Hospital Helios
Berlin, Germany
RECRUITINGUniversity Eye Hospital Vivantes
Berlin, Germany
RECRUITINGUniversity Eye Hospital Bonn
Bonn, Germany
RECRUITING...and 49 more locations