An observational study in Retinopathy of Prematurity, sponsored by University Medicine Greifswald. Recruiting at 59 sites in 12 countries. Per ClinicalTrials.gov, last updated 2024-01-24.
Sponsored by University Medicine Greifswald · Observational
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.
169 studies on the registry are indexed under Retinopathy of Prematurity; 27 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 175 across 57 observational studies indexed under Retinopathy of Prematurity.
Browse Retinopathy of Prematurity studies →University Medicine Greifswald is the lead sponsor of 152 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: Registry of preterm born infants with treatment-requiring ROP
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.
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
Plan to share: No
Started Aug 2021 (actual). Primary completion is estimated for Aug 2038, 204 months after the start.
Of 25 observational studies under Retinopathy of Prematurity, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 53. This study's planned 204 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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