European Disease Registry on Retinopathy of Prematurity (ROP)
EU-ROP
1 other identifier
observational
3,000
11 countries
58
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Longer than P75 for all trials
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2021
CompletedFirst Posted
Study publicly available on registry
June 25, 2021
CompletedStudy Start
First participant enrolled
August 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2038
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2039
January 24, 2024
January 1, 2024
17 years
June 1, 2021
January 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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)
Birth to treatment of ROP, an average of 12 weeks
Treatment parameters at initial treatment
Type of treatment
An average of 12 weeks postnatal age
Treatment parameters at re-treatment
Type of treatment
Through study completion, an average of 20 to 30 weeks postnatal age
ROP stage
Stage of ROP at treatment and during follow-up
Through follow-up after treatment, an average of 1 year postnatal age
Secondary Outcomes (2)
Long-term ophthalmic development
Up to 18 years
Long-term neurologic development
Up to 18 years
Study Arms (1)
Preterm born infants treated for ROP
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- ROP requiring treatment according to the respective national ROP screening and treatment guidelines
You may not qualify if:
- Denial or absence of consent for documentation and electronic storage of personal data by parents or legal guardians
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (59)
University Eye Hospital Salzburg
Salzburg, Austria
University Hospital Saint George
Plovdiv, Bulgaria
Acibadem City Clinic Tokuda Hospital
Sofia, Bulgaria
University Eye Hospital Alexandrovska
Sofia, Bulgaria
University Eye Hospital Tartu
Tartu, Estonia
Hospital Rothschild
Paris, France
University Eye Hospital
Aachen, Germany
University Eye Hospital Helios
Berlin, Germany
University Eye Hospital Vivantes
Berlin, Germany
University Eye Hospital Bonn
Bonn, Germany
Braunschweig Muncipal Hospital
Braunschweig, Germany
University Eye Hospital
Chemnitz, Germany
University Eye Hospital
Cologne, Germany
Carl-Thiem University Hospital Cottbus
Cottbus, Germany
University Eye Hospital
Düsseldorf, Germany
University Eye Hospital
Freiburg im Breisgau, Germany
University Eye Hospital Fulda
Fulda, Germany
University Eye Hospital Gießen
Giessen, Germany
University Eye Hospital
Göttingen, Germany
University Eye Hospital
Greifswald, Germany
University Eye Hospital
Hamburg, Germany
University Eye Hospital Hannover
Hanover, Germany
Facharztpraxis für Augenheilkunde
Ludwigshafen, Germany
University Eye Hospital
Lübeck, Germany
Ludwig-Maximilins-University Munich
Munich, Germany
Augenzentrum am St. Franziskus-Hospital
Münster, Germany
University Eye Hospital
Münster, Germany
Nuremberg South Hospital
Nuremberg, Germany
Ernst-von-Bergmann Hospital
Potsdam, Germany
University Eye Hospital
Regensburg, Germany
University Eye Hospital
Tübingen, Germany
University Eye Hospital Ulm
Ulm, Germany
P&A Kyriakou Athens Children Hospital
Athens, Greece
Department of Ophthalmology University Hospital of Larissa
Larissa, Greece
Aristotle University of Thessaloniki
Thessaloniki, Greece
University Clinical Center of Kosovo
Pristina, Kosovo
Medical University of Bialystok Children's Clinical Hospital
Bialystok, Poland
University Hospital in Bydgoszcz
Bydgoszcz, Poland
University Hospital in Zabrze Silesia
Katowice, Poland
Prof. Dr. Stanislaw Popowski Regional Specialized Children's Hospital
Olsztyn, Poland
University of Medical Sciences Poznan
Poznan, Poland
Children's Memorial Health Institute Warsaw
Warsaw, Poland
Biomédica de Málaga y Plataforma en Nanomedicina
Málaga, Spain
University and Polytechnic Hospital La Fe
Valencia, Spain
University Eye Hospital Genève
Geneva, Switzerland
University Eye Hospital Cukurova
Adana, Turkey (Türkiye)
Etlik Zübeyde Hanim Women's Health Education and Research Hospital
Ankara, Turkey (Türkiye)
Hacettepe University Children's Hospital
Ankara, Turkey (Türkiye)
University Eye Hospital Ankara
Ankara, Turkey (Türkiye)
University Eye Hospital Baskent
Ankara, Turkey (Türkiye)
University Eye Hospital Gazi
Ankara, Turkey (Türkiye)
University Eye Hospital Uludag
Bursa, Turkey (Türkiye)
Umraniye Research and Education Hospital
Istanbul, Turkey (Türkiye)
University Eye Hospital Koc
Istanbul, Turkey (Türkiye)
Ordu University Medical Faculty
Ordu, Turkey (Türkiye)
Ondokuz Mayis University Eye Hospital
Samsun, Turkey (Türkiye)
Department of Pediatric Ophthalmology and Eye Microsurgery Perinatal Center Kiev
Kiev, Ukraine
Kyiv Pediatric Hospital Ohmatdyt
Kiev, Ukraine
Filatov Institute of Eye Diseases and Tissue Therapy Odessa
Odesa, Ukraine
Related Publications (2)
Catt C, Pfeil JM, Barthelmes D, Gole GA, Krohne TU, Wu WC, Kusaka S, Zhao P, Dai S, Elder J, Heckmann M, Stack J, Khonyongwa-Fernandez G, Stahl A. Development of a joint set of database parameters for the EU-ROP and Fight Childhood Blindness! ROP Registries. Br J Ophthalmol. 2024 Jun 20;108(7):1030-1037. doi: 10.1136/bjo-2023-323915.
PMID: 37704267BACKGROUNDWinter K, Pfeil JM, Engmann H, Aisenbrey S, Lorenz B, Hufendiek K, Breuss H, Khattab M, Susskind D, Kakkassery V, Lagreze WA, Barth T, Liegl R, Brunder MC, Skevas C, Goldammer I, Glitz B, Michalewicz E, Krohne TU, Bartmann IR, Stahl A; Retina.net ROP and EU-ROP registry study groups. Comparability of input parameters in the German Retina.net ROP registry and the EU-ROP registry - An exemplary comparison between 2011 and 2021. Acta Ophthalmol. 2024 May;102(3):e314-e321. doi: 10.1111/aos.15753. Epub 2023 Sep 19.
PMID: 37725047RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas Stahl, Professor
Department of Ophthalmology, University Medicine Greifswald
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Target Duration
- 18 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2021
First Posted
June 25, 2021
Study Start
August 6, 2021
Primary Completion (Estimated)
August 1, 2038
Study Completion (Estimated)
August 1, 2039
Last Updated
January 24, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share