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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preterm born infants treated for ROP |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Registry of preterm born infants with treatment-requiring ROP | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term ophthalmic development | Ophthalmic development (e.g. orthoptic status, visual acuity) | Up to 18 years |
| Long-term neurologic development | Neurological developmental (e.g. assessed by psychometric assessments) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas Stahl, Professor | Contact | +49 3834 86 | 5900 | andreas.stahl@med.uni-greifswald.de |
| Johanna M Pfeil, Dr | Contact | +49 3834 86 | 5900 | johanna.pfeil@med.uni-greifswald.de |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Stahl, Professor | Department of Ophthalmology, University Medicine Greifswald | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Eye Hospital Salzburg | Recruiting | Salzburg | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37704267 | Background | 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. | |
| 37725047 |
| Label | URL |
|---|---|
| Project website | View source |
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| Up to 18 years |
| University Hospital Saint George | Recruiting | Plovdiv | Bulgaria |
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| Acibadem City Clinic Tokuda Hospital | Recruiting | Sofia | Bulgaria |
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| University Eye Hospital Alexandrovska | Recruiting | Sofia | Bulgaria |
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| University Eye Hospital Tartu | Recruiting | Tartu | Estonia |
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| Hospital Rothschild | Recruiting | Paris | France |
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| University Eye Hospital | Recruiting | Aachen | Germany |
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| University Eye Hospital Helios | Recruiting | Berlin | Germany |
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| University Eye Hospital Vivantes | Recruiting | Berlin | Germany |
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| University Eye Hospital Bonn | Recruiting | Bonn | Germany |
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| Braunschweig Muncipal Hospital | Recruiting | Braunschweig | Germany |
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| University Eye Hospital | Recruiting | Chemnitz | Germany |
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| University Eye Hospital | Recruiting | Cologne | Germany |
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| Carl-Thiem University Hospital Cottbus | Recruiting | Cottbus | Germany |
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| University Eye Hospital | Recruiting | Düsseldorf | Germany |
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| University Eye Hospital | Recruiting | Freiburg im Breisgau | Germany |
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| University Eye Hospital Fulda | Recruiting | Fulda | Germany |
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| University Eye Hospital Gießen | Recruiting | Giessen | Germany |
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| University Eye Hospital | Recruiting | Göttingen | Germany |
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| University Eye Hospital | Recruiting | Greifswald | Germany |
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| University Eye Hospital | Recruiting | Hamburg | Germany |
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| University Eye Hospital Hannover | Recruiting | Hanover | Germany |
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| Facharztpraxis für Augenheilkunde | Recruiting | Ludwigshafen | Germany |
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| University Eye Hospital | Recruiting | Lübeck | Germany |
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| Ludwig-Maximilins-University Munich | Not yet recruiting | Munich | Germany |
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| Augenzentrum am St. Franziskus-Hospital | Recruiting | Münster | Germany |
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| University Eye Hospital | Recruiting | Münster | Germany |
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| Nuremberg South Hospital | Recruiting | Nuremberg | Germany |
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| Ernst-von-Bergmann Hospital | Recruiting | Potsdam | Germany |
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| University Eye Hospital | Recruiting | Regensburg | Germany |
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| University Eye Hospital | Recruiting | Tübingen | Germany |
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| University Eye Hospital Ulm | Recruiting | Ulm | Germany |
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| P&A Kyriakou Athens Children Hospital | Recruiting | Athens | Greece |
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| Department of Ophthalmology University Hospital of Larissa | Recruiting | Larissa | Greece |
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| Aristotle University of Thessaloniki | Recruiting | Thessaloniki | Greece |
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| University Clinical Center of Kosovo | Recruiting | Pristina | Kosovo |
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| Medical University of Bialystok Children's Clinical Hospital | Recruiting | Bialystok | Poland |
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| University Hospital in Bydgoszcz | Recruiting | Bydgoszcz | Poland |
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| University Hospital in Zabrze Silesia | Recruiting | Katowice | Poland |
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| Prof. Dr. Stanislaw Popowski Regional Specialized Children's Hospital | Recruiting | Olsztyn | Poland |
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| University of Medical Sciences Poznan | Recruiting | Poznan | Poland |
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| Children's Memorial Health Institute Warsaw | Recruiting | Warsaw | Poland |
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| Biomédica de Málaga y Plataforma en Nanomedicina | Recruiting | Málaga | Spain |
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| University and Polytechnic Hospital La Fe | Recruiting | Valencia | Spain |
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| University Eye Hospital Genève | Recruiting | Geneva | Switzerland |
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| University Eye Hospital Cukurova | Recruiting | Adana | Turkey (Türkiye) |
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| Etlik Zübeyde Hanim Women's Health Education and Research Hospital | Recruiting | Ankara | Turkey (Türkiye) |
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| Hacettepe University Children's Hospital | Recruiting | Ankara | Turkey (Türkiye) |
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| University Eye Hospital Ankara | Recruiting | Ankara | Turkey (Türkiye) |
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| University Eye Hospital Baskent | Recruiting | Ankara | Turkey (Türkiye) |
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| University Eye Hospital Gazi | Recruiting | Ankara | Turkey (Türkiye) |
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| University Eye Hospital Uludag | Recruiting | Bursa | Turkey (Türkiye) |
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| Umraniye Research and Education Hospital | Recruiting | Istanbul | Turkey (Türkiye) |
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| University Eye Hospital Koc | Recruiting | Istanbul | Turkey (Türkiye) |
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| Ordu University Medical Faculty | Recruiting | Ordu | Turkey (Türkiye) |
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| Ondokuz Mayis University Eye Hospital | Recruiting | Samsun | Turkey (Türkiye) |
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| Department of Pediatric Ophthalmology and Eye Microsurgery Perinatal Center Kiev | Recruiting | Kiev | Ukraine |
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| Kyiv Pediatric Hospital Ohmatdyt | Recruiting | Kiev | Ukraine |
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| Filatov Institute of Eye Diseases and Tissue Therapy Odessa | Recruiting | Odesa | Ukraine |
|
| 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. |
| ID | Term |
|---|---|
| D012178 | Retinopathy of Prematurity |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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