NCT Number: NCT04939571
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.
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Observational
University Eye Hospital Salzburg, Salzburg, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Birth to treatment of ROP, an average of 12 weeks
Birth weight, gestational age, weight at treatment, comorbidities (e.g. sepsis, necrotizing enterocolitis)
Time frame: An average of 12 weeks postnatal age
Type of treatment
Time frame: Through study completion, an average of 20 to 30 weeks postnatal age
Type of treatment
Time frame: Through follow-up after treatment, an average of 1 year postnatal age
Stage of ROP at treatment and during follow-up
Time frame: Up to 18 years
Ophthalmic development (e.g. orthoptic status, visual acuity)
Time frame: Up to 18 years
Neurological developmental (e.g. assessed by psychometric assessments)
Contact information is provided by the study sponsor or research team.
Andreas Stahl, Professor
CONTACT
+49 3834 86 ext. 5900
Johanna M Pfeil, Dr
CONTACT
+49 3834 86 ext. 5900
University Medicine Greifswald
Other
Acronym: EU-ROP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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