European Disease Registry on Retinopathy of Prematurity (ROP)
ConditionRetinopathy of Prematurity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity Medicine Greifswald
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
ROP requiring treatment according to the respective national ROP screening and treatment guidelines
Disqualifiers
Denial or absence of consent for documentation and electronic storage of personal data by parents or legal guardians
Trial population
All infants Europe wide with ROP requiring treatment can be entered into the registry. 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.
Trial design
Design model
Case-only
Time perspective
Other
Treatments tested in this trial
Registry of preterm born infants with treatment-requiring ROP
Other interventionAll 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.
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: Preterm born infants treated for ROP1 intervention
Trial outcomes
Primary outcomes
1
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 weeks2
Treatment parameters at initial treatment
Type of treatment
Time frame
An average of 12 weeks postnatal age3
Treatment parameters at re-treatment
Type of treatment
Time frame
Through study completion, an average of 20 to 30 weeks postnatal age4
ROP stage
Stage of ROP at treatment and during follow-up
Time frame
Through follow-up after treatment, an average of 1 year postnatal ageSecondary outcomes
1
Long-term ophthalmic development
Ophthalmic development (e.g. orthoptic status, visual acuity)
Time frame
Up to 18 years2
Long-term neurologic development
Neurological developmental (e.g. assessed by psychometric assessments)
Time frame
Up to 18 yearsSponsors and contacts
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Source ClinicalTrials.gov