European Disease Registry on Retinopathy of Prematurity (ROP)

Study Overview
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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.

Official Title
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European Disease Registry on Retinopathy of Prematurity (ROP)

Conditions
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Retinopathy of Prematurity

Intervention / Treatment
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* Other: Registry of preterm born infants with treatment-requiring ROP


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preterm born infants treated for ROP<br> | Other: Registry of preterm born infants with treatment-requiring ROP<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | Up to 18 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ROP, anti-VEGF, laser coagulation, epidemiology, non-interventional study