Development of a joint set of database parameters for the EU-ROP and Fight Childhood Blindness! ROP Registries.
Caroline Catt, Johanna M Pfeil, Daniel Barthelmes...
https://pubmed.ncbi.nlm.nih.gov/37704267Actively Recruiting
All Genders
ID04939571
European Disease Registry on Retinopathy of Prematurity (ROP)
Led by University Medicine Greifswald · Updated on 2024-01-24
3000
Participants Needed
59
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to collect comprehensive information on infants treated for retinopathy of prematurity (ROP) across multiple European countries. It is an observational registry study designed to gather data on the natural history of severe ROP, including variations in the disease's clinical features and progression, as well as treatment and follow-up patterns. The study is open-ended and includes infants regardless of the treatment method used at participating centers. The study involves enrolling preterm infants who require treatment for ROP according to national guidelines. No additional examinations or interventions are performed beyond routine clinical care. Data collected include baseline characteristics, treatment details at initial therapy and any re-treatments, and the stage of ROP through follow-up. Long-term ophthalmic and neurological development will also be tracked for up to 18 years. Participants' clinical routine data are collected and documented electronically, focusing on treatment timing, disease progression, and outcomes. The primary outcomes include baseline data from birth to treatment, treatment parameters, and ROP stage through follow-up, typically spanning from birth to about one year. Secondary outcomes assess long-term eye and neurological health. This registry does not involve active treatment assignment and continues collecting data from infants treated at participating centers.
CONDITIONS
Brief Title
European Disease Registry on Retinopathy of Prematurity (ROP)
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Retinopathy of prematurity requiring treatment according to national screening and treatment guidelines
You will not qualify if you...
- Denial or absence of consent for documentation and electronic storage of personal data by parents or legal guardians
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Monitoring
Duration - From birth to approximately 18 years postnatal age
Participants who undergo routine care for treatment-requiring retinopathy of prematurity are observed and their treatment parameters and disease progression are documented.
Trial Site Locations
Total: 59 locations
1
University Eye Hospital Salzburg
Salzburg, Austria
Actively Recruiting
2
University Hospital Saint George
Plovdiv, Bulgaria
Actively Recruiting
3
Acibadem City Clinic Tokuda Hospital
Sofia, Bulgaria
Actively Recruiting
4
University Eye Hospital Alexandrovska
Sofia, Bulgaria
Actively Recruiting
5
University Eye Hospital Tartu
Tartu, Estonia
Actively Recruiting
6
Hospital Rothschild
Paris, France
Actively Recruiting
7
University Eye Hospital
Aachen, Germany
Actively Recruiting
8
University Eye Hospital Helios
Berlin, Germany
Actively Recruiting
9
University Eye Hospital Vivantes
Berlin, Germany
Actively Recruiting
10
University Eye Hospital Bonn
Bonn, Germany
Actively Recruiting
11
Braunschweig Muncipal Hospital
Braunschweig, Germany
Actively Recruiting
12
University Eye Hospital
Chemnitz, Germany
Actively Recruiting
13
University Eye Hospital
Cologne, Germany
Actively Recruiting
14
Carl-Thiem University Hospital Cottbus
Cottbus, Germany
Actively Recruiting
15
University Eye Hospital
Düsseldorf, Germany
Actively Recruiting
16
University Eye Hospital
Freiburg im Breisgau, Germany
Actively Recruiting
17
University Eye Hospital Fulda
Fulda, Germany
Actively Recruiting
18
University Eye Hospital Gießen
Giessen, Germany
Actively Recruiting
19
University Eye Hospital
Göttingen, Germany
Actively Recruiting
20
University Eye Hospital
Greifswald, Germany
Actively Recruiting
21
University Eye Hospital
Hamburg, Germany
Actively Recruiting
22
University Eye Hospital Hannover
Hanover, Germany
Actively Recruiting
23
Facharztpraxis für Augenheilkunde
Ludwigshafen, Germany
Actively Recruiting
24
University Eye Hospital
Lübeck, Germany
Actively Recruiting
25
Ludwig-Maximilins-University Munich
Munich, Germany
Not Yet Recruiting
26
Augenzentrum am St. Franziskus-Hospital
Münster, Germany
Actively Recruiting
27
University Eye Hospital
Münster, Germany
Actively Recruiting
28
Nuremberg South Hospital
Nuremberg, Germany
Actively Recruiting
29
Ernst-von-Bergmann Hospital
Potsdam, Germany
Actively Recruiting
30
University Eye Hospital
Regensburg, Germany
Actively Recruiting
31
University Eye Hospital
Tübingen, Germany
Actively Recruiting
32
University Eye Hospital Ulm
Ulm, Germany
Actively Recruiting
33
P&A Kyriakou Athens Children Hospital
Athens, Greece
Actively Recruiting
34
Department of Ophthalmology University Hospital of Larissa
Larissa, Greece
Actively Recruiting
35
Aristotle University of Thessaloniki
Thessaloniki, Greece
Actively Recruiting
36
University Clinical Center of Kosovo
Pristina, Kosovo
Actively Recruiting
37
Medical University of Bialystok Children's Clinical Hospital
Bialystok, Poland
Actively Recruiting
38
University Hospital in Bydgoszcz
Bydgoszcz, Poland
Actively Recruiting
39
University Hospital in Zabrze Silesia
Katowice, Poland
Actively Recruiting
40
Prof. Dr. Stanislaw Popowski Regional Specialized Children's Hospital
Olsztyn, Poland
Actively Recruiting
41
University of Medical Sciences Poznan
Poznan, Poland
Actively Recruiting
42
Children's Memorial Health Institute Warsaw
Warsaw, Poland
Actively Recruiting
43
Biomédica de Málaga y Plataforma en Nanomedicina
Málaga, Spain
Actively Recruiting
44
University and Polytechnic Hospital La Fe
Valencia, Spain
Actively Recruiting
45
University Eye Hospital Genève
Geneva, Switzerland
Actively Recruiting
46
University Eye Hospital Cukurova
Adana, Turkey (Türkiye)
Actively Recruiting
47
Etlik Zübeyde Hanim Women's Health Education and Research Hospital
Ankara, Turkey (Türkiye)
Actively Recruiting
48
Hacettepe University Children's Hospital
Ankara, Turkey (Türkiye)
Actively Recruiting
49
University Eye Hospital Ankara
Ankara, Turkey (Türkiye)
Actively Recruiting
50
University Eye Hospital Baskent
Ankara, Turkey (Türkiye)
Actively Recruiting
51
University Eye Hospital Gazi
Ankara, Turkey (Türkiye)
Actively Recruiting
52
University Eye Hospital Uludag
Bursa, Turkey (Türkiye)
Actively Recruiting
53
Umraniye Research and Education Hospital
Istanbul, Turkey (Türkiye)
Actively Recruiting
54
University Eye Hospital Koc
Istanbul, Turkey (Türkiye)
Actively Recruiting
55
Ordu University Medical Faculty
Ordu, Turkey (Türkiye)
Actively Recruiting
56
Ondokuz Mayis University Eye Hospital
Samsun, Turkey (Türkiye)
Actively Recruiting
57
Department of Pediatric Ophthalmology and Eye Microsurgery Perinatal Center Kiev
Kiev, Ukraine
Actively Recruiting
58
Kyiv Pediatric Hospital Ohmatdyt
Kiev, Ukraine
Actively Recruiting
59
Filatov Institute of Eye Diseases and Tissue Therapy Odessa
Odesa, Ukraine
Actively Recruiting
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Research Team
A
Andreas Stahl, Professor
J
Johanna M Pfeil, Dr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Comparability of input parameters in the German Retina.net ROP registry and the EU-ROP registry - An exemplary comparison between 2011 and 2021.
K Winter, J M Pfeil, H Engmann...
https://pubmed.ncbi.nlm.nih.gov/37725047