European Disease Registry on Retinopathy of Prematurity (ROP)

Overview

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.

Interventions

• 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.

Primary outcome measures

• 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]
• Treatment parameters at initial treatment [Time frame: 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]
• ROP stage [Time frame: Through follow-up after treatment, an average of 1 year postnatal age]

Secondary outcome measures (2)

• Long-term ophthalmic development [Time frame: Up to 18 years]
• Long-term neurologic development [Time frame: Up to 18 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Germany · 26 centers

• University Eye Hospital — Aachen
• University Eye Hospital Helios — Berlin
• University Eye Hospital Vivantes — Berlin
• University Eye Hospital Bonn — Bonn
• Braunschweig Muncipal Hospital — Braunschweig
• University Eye Hospital — Chemnitz
• University Eye Hospital — Cologne
• Carl-Thiem University Hospital Cottbus — Cottbus
• … and 18 more centers

Turkey (Türkiye) · 11 centers

• University Eye Hospital Cukurova — Adana
• Etlik Zübeyde Hanim Women's Health Education and Research Hospital — Ankara
• Hacettepe University Children's Hospital — Ankara
• University Eye Hospital Ankara — Ankara
• University Eye Hospital Baskent — Ankara
• University Eye Hospital Gazi — Ankara
• University Eye Hospital Uludag — Bursa
• Umraniye Research and Education Hospital — Istanbul
• … and 3 more centers

Poland · 6 centers

• Medical University of Bialystok Children's Clinical Hospital — Bialystok
• University Hospital in Bydgoszcz — Bydgoszcz
• University Hospital in Zabrze Silesia — Katowice
• Prof. Dr. Stanislaw Popowski Regional Specialized Children's Hospital — Olsztyn
• University of Medical Sciences Poznan — Poznan
• Children's Memorial Health Institute Warsaw — Warsaw

Bulgaria · 3 centers

• University Hospital Saint George — Plovdiv
• Acibadem City Clinic Tokuda Hospital — Sofia
• University Eye Hospital Alexandrovska — Sofia

Greece · 3 centers

• P&A Kyriakou Athens Children Hospital — Athens
• Department of Ophthalmology University Hospital of Larissa — Larissa
• Aristotle University of Thessaloniki — Thessaloniki

Ukraine · 3 centers

• Department of Pediatric Ophthalmology and Eye Microsurgery Perinatal Center Kiev — Kiev
• Kyiv Pediatric Hospital Ohmatdyt — Kiev
• Filatov Institute of Eye Diseases and Tissue Therapy Odessa — Odesa

Spain · 2 centers

• Biomédica de Málaga y Plataforma en Nanomedicina — Málaga
• University and Polytechnic Hospital La Fe — Valencia

Austria · 1 center

• University Eye Hospital Salzburg — Salzburg

Estonia · 1 center

• University Eye Hospital Tartu — Tartu

France · 1 center

• Hospital Rothschild — Paris

Kosovo · 1 center

• University Clinical Center of Kosovo — Pristina

Switzerland · 1 center

• University Eye Hospital Genève — Geneva

Publications

• 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 37704267
• 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 comp PMID 37725047

Identifiers

NCT: NCT04939571 · EU-ROP

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗