European Disease Registry on Retinopathy of Prematurity (ROP) (EU-ROP)

January 22, 2024 updated by: University Medicine Greifswald

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Salzburg, Austria
        • Recruiting
        • University Eye Hospital Salzburg
        • Contact:
          • Herbert Reitsamer
  • Bulgaria
      • Plovdiv, Bulgaria
        • Recruiting
        • University Hospital Saint George
        • Contact:
          • Vasil G Marinov
      • Sofia, Bulgaria
        • Recruiting
        • Acibadem City Clinic Tokuda Hospital
        • Contact:
          • Lilyana P Dimitrova
      • Sofia, Bulgaria
        • Recruiting
        • University Eye Hospital Alexandrovska
        • Contact:
          • Alexander H Oscar
  • Estonia
      • Tartu, Estonia
        • Recruiting
        • University Eye Hospital Tartu
        • Contact:
          • Mikk Pauklin
  • France
      • Paris, France
        • Recruiting
        • Hospital Rothschild
        • Contact:
          • Georges Caputo
  • Germany
      • Aachen, Germany
        • Recruiting
        • University Eye Hospital
        • Contact:
          • Peter Walter
      • Berlin, Germany
        • Recruiting
        • University Eye Hospital Helios
        • Contact:
          • Helge Breuss
      • Berlin, Germany
        • Recruiting
        • University Eye Hospital Vivantes
        • Contact:
          • Sabine Aisenbrey
      • Bonn, Germany
        • Recruiting
        • University Eye Hospital Bonn
        • Contact:
          • Raffael Liegl
      • Braunschweig, Germany
        • Recruiting
        • Braunschweig Muncipal Hospital
        • Contact:
          • Erik Chankiewitz
      • Chemnitz, Germany
        • Recruiting
        • University Eye Hospital
        • Contact:
          • Vinodh Kakkassery
      • Cologne, Germany
        • Recruiting
        • University Eye Hospital
        • Contact:
          • Tim U Krohne
      • Cottbus, Germany
        • Recruiting
        • Carl-Thiem University Hospital Cottbus
        • Contact:
          • Lars Geerdts
      • Düsseldorf, Germany
        • Recruiting
        • University Eye Hospital
        • Contact:
          • Rainer Guthoff
      • Freiburg, Germany
        • Recruiting
        • University Eye Hospital
        • Contact:
          • Wolf A Lagrèze
      • Fulda, Germany
        • Recruiting
        • University Eye Hospital Fulda
        • Contact:
          • Iva-Ruth Barthmann
      • Gießen, Germany
        • Recruiting
        • University Eye Hospital Gießen
        • Contact:
          • Monika Andrassi-Darida
      • Greifswald, Germany
        • Recruiting
        • University Eye Hospital
        • Contact:
          • Andreas Stahl
      • Göttingen, Germany
        • Recruiting
        • University Eye Hospital
        • Contact:
          • Mohammed Khattab
      • Hamburg, Germany
        • Recruiting
        • University Eye Hospital
        • Contact:
          • Martin Spitzer
      • Hannover, Germany
        • Recruiting
        • University Eye Hospital Hannover
        • Contact:
          • Karsten Hufendiek
      • Ludwigshafen, Germany
        • Recruiting
        • Facharztpraxis für Augenheilkunde
        • Contact:
          • Waldemar Jendritza
      • Lübeck, Germany
        • Recruiting
        • University Eye Hospital
        • Contact:
          • Salvatore Grisanti
      • Munich, Germany
        • Not yet recruiting
        • Ludwig-Maximilins-University Munich
        • Contact:
          • Oliver Ehrt
      • Münster, Germany
        • Recruiting
        • University Eye Hospital
        • Contact:
          • Barbara Glitz
      • Münster, Germany
        • Recruiting
        • Augenzentrum am St. Franziskus-Hospital
        • Contact:
          • Georg Spital
      • Nuremberg, Germany
        • Recruiting
        • Nuremberg South Hospital
        • Contact:
          • Florian Bauer
      • Potsdam, Germany
        • Recruiting
        • Ernst-von-Bergmann Hospital
        • Contact:
          • Ameli Gabel-Pfisterer
      • Regensburg, Germany
        • Recruiting
        • University Eye Hospital
        • Contact:
          • Teresa Barth
      • Tübingen, Germany
        • Recruiting
        • University Eye Hospital
        • Contact:
          • Daniela Süsskind
      • Ulm, Germany
        • Recruiting
        • University Eye Hospital Ulm
        • Contact:
          • Armin Wolf
  • Greece
      • Athens, Greece
        • Recruiting
        • P&A Kyriakou Athens Children Hospital
        • Contact:
          • Agathi Kouri
      • Larissa, Greece
        • Recruiting
        • Department of Ophthalmology University Hospital of Larissa
        • Contact:
          • Elena Papageorgiou
      • Thessaloníki, Greece
        • Recruiting
        • Aristotle University of Thessaloniki
        • Contact:
          • Asimina Mataftsi
  • Kosovo
      • Pristina, Kosovo
        • Recruiting
        • University Clinical Center of Kosovo
        • Contact:
          • Belinda Pustina
  • Poland
      • Białystok, Poland
        • Recruiting
        • Medical University of Bialystok Children's Clinical Hospital
        • Contact:
          • Monika Ozieblo-Kupczyk
      • Bydgoszcz, Poland
        • Recruiting
        • University Hospital in Bydgoszcz
        • Contact:
          • Magdalena Kaszuba-Modrzejewska
      • Katowice, Poland
        • Recruiting
        • University Hospital in Zabrze Silesia
        • Contact:
          • Bogumila Wójcik-Niklewska
      • Olsztyn, Poland
        • Recruiting
        • Prof. Dr. Stanislaw Popowski Regional Specialized Children's Hospital
        • Contact:
          • Maria Szwajkowska
      • Poznań, Poland
        • Recruiting
        • University of Medical Sciences Poznan
        • Contact:
          • Anna Gotz-Wieckowska
      • Warsaw, Poland
        • Recruiting
        • Children's Memorial Health Institute Warsaw
        • Contact:
          • Wojciech Hautz
  • Spain
      • Málaga, Spain
        • Recruiting
        • Biomédica de Málaga y Plataforma en Nanomedicina
        • Contact:
          • Julia Escudero
      • Valencia, Spain
        • Recruiting
        • University and Polytechnic Hospital La Fe
        • Contact:
          • Isabel Pascual-Camps
  • Switzerland
      • Geneva, Switzerland
        • Recruiting
        • University Eye Hospital Genève
        • Contact:
          • Gabriele Thumann
  • Turkey
      • Adana, Turkey
        • Recruiting
        • University Eye Hospital Cukurova
        • Contact:
          • Hacer Y Yildizdas
      • Ankara, Turkey
        • Recruiting
        • Etlik Zubeyde Hanim Women's Health Education and Research Hospital
        • Contact:
          • Caner Kara
      • Ankara, Turkey
        • Recruiting
        • Hacettepe University Children's Hospital
        • Contact:
          • Irem Iyigün
      • Ankara, Turkey
        • Recruiting
        • University Eye Hospital Ankara
        • Contact:
          • Huban Atilla
      • Ankara, Turkey
        • Recruiting
        • University Eye Hospital Baskent
        • Contact:
          • Imren Akkoyun
      • Ankara, Turkey
        • Recruiting
        • University Eye Hospital Gazi
        • Contact:
          • Sengul Ozdek
      • Bursa, Turkey
        • Recruiting
        • University Eye Hospital Uludag
        • Contact:
          • Nilgun Koksal
      • Istanbul, Turkey
        • Recruiting
        • University Eye Hospital Koc
        • Contact:
          • Ayse Y Tas
      • Istanbul, Turkey
        • Recruiting
        • Umraniye research and education hospital
        • Contact:
          • Gulay Karakus
      • Ordu, Turkey
        • Recruiting
        • Ordu University Medical Faculty
        • Contact:
          • Aslihan Uzun
      • Samsun, Turkey
        • Recruiting
        • Ondokuz Mayis University Eye Hospital
        • Contact:
          • Ozlem E Yucel
  • Ukraine
      • Kiev, Ukraine
        • Recruiting
        • Department of Pediatric Ophthalmology and Eye Microsurgery Perinatal Center Kiev
        • Contact:
          • Lupyr Sergii
      • Kiev, Ukraine
        • Recruiting
        • Kyiv Pediatric Hospital Ohmatdyt
        • Contact:
          • Kateryna Fedchuk
      • Odesa, Ukraine
        • Recruiting
        • Filatov Institute of Eye Diseases and Tissue Therapy Odessa
        • Contact:
          • Katsan S Volodymyrovych

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Preterm born infants treated for ROP
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline data of preterm born infants who develop treatment-requiring retinopathy of prematurity
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)
Birth to treatment of ROP, an average of 12 weeks
Treatment parameters at initial treatment
Time Frame: An average of 12 weeks postnatal age
Type of treatment
An average of 12 weeks postnatal age
Treatment parameters at re-treatment
Time Frame: Through study completion, an average of 20 to 30 weeks postnatal age
Type of treatment
Through study completion, an average of 20 to 30 weeks postnatal age
ROP stage
Time Frame: Through follow-up after treatment, an average of 1 year postnatal age
Stage of ROP at treatment and during follow-up
Through follow-up after treatment, an average of 1 year postnatal age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term ophthalmic development
Time Frame: Up to 18 years
Ophthalmic development (e.g. orthoptic status, visual acuity)
Up to 18 years
Long-term neurologic development
Time Frame: Up to 18 years
Neurological developmental (e.g. assessed by psychometric assessments)
Up to 18 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Investigators

  • Principal Investigator: Andreas Stahl, Professor, Department of Ophthalmology, University Medicine Greifswald

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2021

Primary Completion (Estimated)

August 1, 2038

Study Completion (Estimated)

August 1, 2039

Study Registration Dates

First Submitted

June 1, 2021

First Submitted That Met QC Criteria

June 16, 2021

First Posted (Actual)

June 25, 2021

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EU-ROP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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