European Disease Registry on Retinopathy of Prematurity (ROP)

NCT ID: NCT04939571

Last Updated: 2024-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-06

Study Completion Date

2039-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Retinopathy of Prematurity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Preterm born infants treated for ROP

Registry of preterm born infants with treatment-requiring ROP

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ROP requiring treatment according to the respective national ROP screening and treatment guidelines

Exclusion Criteria

* Denial or absence of consent for documentation and electronic storage of personal data by parents or legal guardians
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Stahl, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, University Medicine Greifswald

Locations

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University Eye Hospital Salzburg

Salzburg, , Austria

Site Status RECRUITING

University Hospital Saint George

Plovdiv, , Bulgaria

Site Status RECRUITING

Acibadem City Clinic Tokuda Hospital

Sofia, , Bulgaria

Site Status RECRUITING

University Eye Hospital Alexandrovska

Sofia, , Bulgaria

Site Status RECRUITING

University Eye Hospital Tartu

Tartu, , Estonia

Site Status RECRUITING

Hospital Rothschild

Paris, , France

Site Status RECRUITING

University Eye Hospital

Aachen, , Germany

Site Status RECRUITING

University Eye Hospital Helios

Berlin, , Germany

Site Status RECRUITING

University Eye Hospital Vivantes

Berlin, , Germany

Site Status RECRUITING

University Eye Hospital Bonn

Bonn, , Germany

Site Status RECRUITING

Braunschweig Muncipal Hospital

Braunschweig, , Germany

Site Status RECRUITING

University Eye Hospital

Chemnitz, , Germany

Site Status RECRUITING

University Eye Hospital

Cologne, , Germany

Site Status RECRUITING

Carl-Thiem University Hospital Cottbus

Cottbus, , Germany

Site Status RECRUITING

University Eye Hospital

Düsseldorf, , Germany

Site Status RECRUITING

University Eye Hospital

Freiburg im Breisgau, , Germany

Site Status RECRUITING

University Eye Hospital Fulda

Fulda, , Germany

Site Status RECRUITING

University Eye Hospital Gießen

Giessen, , Germany

Site Status RECRUITING

University Eye Hospital

Göttingen, , Germany

Site Status RECRUITING

University Eye Hospital

Greifswald, , Germany

Site Status RECRUITING

University Eye Hospital

Hamburg, , Germany

Site Status RECRUITING

University Eye Hospital Hannover

Hanover, , Germany

Site Status RECRUITING

Facharztpraxis für Augenheilkunde

Ludwigshafen, , Germany

Site Status RECRUITING

University Eye Hospital

Lübeck, , Germany

Site Status RECRUITING

Ludwig-Maximilins-University Munich

Munich, , Germany

Site Status NOT_YET_RECRUITING

Augenzentrum am St. Franziskus-Hospital

Münster, , Germany

Site Status RECRUITING

University Eye Hospital

Münster, , Germany

Site Status RECRUITING

Nuremberg South Hospital

Nuremberg, , Germany

Site Status RECRUITING

Ernst-von-Bergmann Hospital

Potsdam, , Germany

Site Status RECRUITING

University Eye Hospital

Regensburg, , Germany

Site Status RECRUITING

University Eye Hospital

Tübingen, , Germany

Site Status RECRUITING

University Eye Hospital Ulm

Ulm, , Germany

Site Status RECRUITING

P&A Kyriakou Athens Children Hospital

Athens, , Greece

Site Status RECRUITING

Department of Ophthalmology University Hospital of Larissa

Larissa, , Greece

Site Status RECRUITING

Aristotle University of Thessaloniki

Thessaloniki, , Greece

Site Status RECRUITING

University Clinical Center of Kosovo

Pristina, , Kosovo

Site Status RECRUITING

Medical University of Bialystok Children's Clinical Hospital

Bialystok, , Poland

Site Status RECRUITING

University Hospital in Bydgoszcz

Bydgoszcz, , Poland

Site Status RECRUITING

University Hospital in Zabrze Silesia

Katowice, , Poland

Site Status RECRUITING

Prof. Dr. Stanislaw Popowski Regional Specialized Children's Hospital

Olsztyn, , Poland

Site Status RECRUITING

University of Medical Sciences Poznan

Poznan, , Poland

Site Status RECRUITING

Children's Memorial Health Institute Warsaw

Warsaw, , Poland

Site Status RECRUITING

Biomédica de Málaga y Plataforma en Nanomedicina

Málaga, , Spain

Site Status RECRUITING

University and Polytechnic Hospital La Fe

Valencia, , Spain

Site Status RECRUITING

University Eye Hospital Genève

Geneva, , Switzerland

Site Status RECRUITING

University Eye Hospital Cukurova

Adana, , Turkey (Türkiye)

Site Status RECRUITING

Etlik Zübeyde Hanim Women's Health Education and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Hacettepe University Children's Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

University Eye Hospital Ankara

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

University Eye Hospital Baskent

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

University Eye Hospital Gazi

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

University Eye Hospital Uludag

Bursa, , Turkey (Türkiye)

Site Status RECRUITING

Umraniye Research and Education Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

University Eye Hospital Koc

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Ordu University Medical Faculty

Ordu, , Turkey (Türkiye)

Site Status RECRUITING

Ondokuz Mayis University Eye Hospital

Samsun, , Turkey (Türkiye)

Site Status RECRUITING

Department of Pediatric Ophthalmology and Eye Microsurgery Perinatal Center Kiev

Kiev, , Ukraine

Site Status RECRUITING

Kyiv Pediatric Hospital Ohmatdyt

Kiev, , Ukraine

Site Status RECRUITING

Filatov Institute of Eye Diseases and Tissue Therapy Odessa

Odesa, , Ukraine

Site Status RECRUITING

Countries

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Austria Bulgaria Estonia France Germany Greece Kosovo Poland Spain Switzerland Turkey (Türkiye) Ukraine

Central Contacts

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Andreas Stahl, Professor

Role: CONTACT

+49 3834 86 ext. 5900

Johanna M Pfeil, Dr

Role: CONTACT

+49 3834 86 ext. 5900

Facility Contacts

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Herbert Reitsamer

Role: primary

Vasil G Marinov

Role: primary

Lilyana P Dimitrova

Role: primary

Alexander H Oscar

Role: primary

Mikk Pauklin

Role: primary

Georges Caputo

Role: primary

Peter Walter

Role: primary

Helge Breuss

Role: primary

Sabine Aisenbrey

Role: primary

Raffael Liegl

Role: primary

Erik Chankiewitz

Role: primary

Vinodh Kakkassery

Role: primary

Tim U Krohne

Role: primary

Lars Geerdts

Role: primary

Rainer Guthoff

Role: primary

Wolf A Lagrèze

Role: primary

Iva-Ruth Barthmann

Role: primary

Monika Andrassi-Darida

Role: primary

Mohammed Khattab

Role: primary

Andreas Stahl

Role: primary

Martin Spitzer

Role: primary

Karsten Hufendiek

Role: primary

Waldemar Jendritza

Role: primary

Salvatore Grisanti

Role: primary

Oliver Ehrt

Role: primary

Georg Spital

Role: primary

Barbara Glitz

Role: primary

Florian Bauer

Role: primary

Ameli Gabel-Pfisterer

Role: primary

Teresa Barth

Role: primary

Daniela Süsskind

Role: primary

Armin Wolf

Role: primary

Agathi Kouri

Role: primary

Elena Papageorgiou

Role: primary

Asimina Mataftsi

Role: primary

Belinda Pustina

Role: primary

Monika Ozieblo-Kupczyk

Role: primary

Magdalena Kaszuba-Modrzejewska

Role: primary

Bogumila Wójcik-Niklewska

Role: primary

Maria Szwajkowska

Role: primary

Anna Gotz-Wieckowska

Role: primary

Wojciech Hautz

Role: primary

Julia Escudero

Role: primary

Isabel Pascual-Camps

Role: primary

Gabriele Thumann

Role: primary

Hacer Y Yildizdas

Role: primary

Caner Kara

Role: primary

Irem Iyigün

Role: primary

Huban Atilla

Role: primary

Imren Akkoyun

Role: primary

Sengul Ozdek

Role: primary

Nilgun Koksal

Role: primary

Gulay Karakus

Role: primary

Ayse Y Tas

Role: primary

Aslihan Uzun

Role: primary

Ozlem E Yucel

Role: primary

Lupyr Sergii

Role: primary

Kateryna Fedchuk

Role: primary

Katsan S Volodymyrovych

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 37704267 (View on PubMed)

Winter 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.

Reference Type RESULT
PMID: 37725047 (View on PubMed)

Related Links

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http://www.eu-rop.org

Project website

Other Identifiers

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EU-ROP

Identifier Type: -

Identifier Source: org_study_id

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