RecruitingOBSERVATIONAL

European Disease Registry on Retinopathy of Prematurity (ROP)

This study, called the EU-ROP registry, is collecting information about premature babies in many different European countries who have a serious eye condition called Retinopathy of Prematurity (ROP). It's not a study where new treatments are tested; instead, it simply observes and records how ROP affects babies over time and what kinds of treatments they receive. Doctors want to understand the different ways ROP can show up, how it progresses, and what the long-term results are for babies receiving treatment. By gathering this information from many patients, researchers hope to improve care for premature babies with ROP in the future.

At a glance

Status

Recruiting

Sponsor

University Medicine Greifswald

Enrolment target

3,000

Start

06 Aug 2021

Estimated completion

01 Aug 2039

Retinopathy of Prematurity

What is this study about?

Imagine a big, ongoing notebook where doctors in many different hospitals across Europe are writing down important details about babies born too early who develop a serious eye problem called Retinopathy of Prematurity (ROP). That's essentially what the EU-ROP registry is. It's not testing new medicines or treatments; instead, it's observing what's already happening. Doctors are simply recording information from a baby's regular check-ups and treatments, almost like taking a snapshot of their journey with ROP.

The main goal of this 'notebook' is to help doctors get a clearer picture of ROP. They want to understand how the condition affects babies in different ways, how it progresses over time, and what kinds of treatments are being used successfully. They also want to see what happens to these babies' eyes in the long run after their treatment. By collecting information from many babies in many different countries, doctors can compare notes and learn from each other's experiences.

This kind of study is really important because it helps medical professionals learn more about a condition in the real world. This knowledge can then be used to improve how ROP is screened for, treated, and followed up in the future, ultimately leading to better care for premature babies affected by this condition. It's all about gathering facts to make future care even better.

Key takeaways

This study collects information about premature babies with ROP.
It helps doctors understand ROP better across Europe.
Your baby's regular care and visits will not change.
No new treatments or tests are part of this study.
Your consent is important for your baby to participate.
The goal is to improve care for babies with ROP in the future.

Who may be eligible?

This study is looking for premature babies who have Retinopathy of Prematurity (ROP) and need treatment for it. This means their eye condition is serious enough that their doctors have decided treatment is necessary, following the standard guidelines in their country.

It's important that the parents or legal guardians of the baby agree for their child's medical information to be collected and stored electronically for the study. If consent is not given, or if it is withdrawn, then the baby would not be able to participate. This study is open to babies of all ages and both sexes.

Basically, if your premature baby has ROP that needs treatment and you're happy for their routine medical details to be shared anonymously with the study, they could be included.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your baby premature?
Does your baby have Retinopathy of Prematurity (ROP)?
Does your baby's ROP require active treatment?
Are you, as a parent or guardian, happy for your baby's routine medical details to be part of this study?

Answer every question to see your result.

What does participation involve?

If your baby is included in this study, it's important to understand that there will be no extra visits, tests, or treatments. This is not a study where your baby will receive a new or experimental medication. Instead, the doctors will simply collect information from your baby's regular medical records and appointments related to their ROP treatment and follow-up. This information includes details about their eye condition, the treatments they receive, and how their eyes are doing over time. This collection will happen as long as the study is running, but it won't change your baby's routine medical care in any way.

Potential risks and benefits

There are no direct risks or benefits to your baby from taking part in this study, as it only involves collecting information from their routine medical care. Your baby will not undergo any additional tests or procedures. The main benefit is that the information gathered will help doctors and researchers worldwide better understand Retinopathy of Prematurity (ROP) and improve care for other babies in the future. You have the right to withdraw your consent for your baby's data to be included at any time, without affecting their medical care.

Locations (59)

University Eye Hospital Salzburg
Verified postcode
Salzburg, Austria· Recruiting
University Hospital Saint George
Verified postcode
Plovdiv, Bulgaria· Recruiting
Acibadem City Clinic Tokuda Hospital
Verified postcode
Sofia, Bulgaria· Recruiting
University Eye Hospital Alexandrovska
Verified postcode
Sofia, Bulgaria· Recruiting
University Eye Hospital Tartu
Verified postcode
Tartu, Estonia· Recruiting
Hospital Rothschild
Verified postcode
Paris, France· Recruiting
University Eye Hospital
Verified postcode
Aachen, Germany· Recruiting
University Eye Hospital Helios
Verified postcode
Berlin, Germany· Recruiting
University Eye Hospital Vivantes
Verified postcode
Berlin, Germany· Recruiting
University Eye Hospital Bonn
Verified postcode
Bonn, Germany· Recruiting
Braunschweig Muncipal Hospital
Verified postcode
Braunschweig, Germany· Recruiting
University Eye Hospital
Verified postcode
Chemnitz, Germany· Recruiting

Common questions

What is Retinopathy of Prematurity (ROP)?

ROP is an eye condition that can affect premature babies, causing problems with the development of blood vessels in their eyes.

Will my baby get any special treatment in this study?

No, your baby will receive the standard medical care for ROP that their doctor recommends. The study only collects information about this care.

Do I need to take my baby for extra hospital visits?

No, participating in this study does not involve any extra hospital visits or appointments for your baby.

Who will see my baby's information?

The information collected is anonymised where possible and will be used by researchers to understand ROP better. Your baby's personal details will be kept confidential.

Can I change my mind about my baby being in the study?

Yes, you can decide at any point that you no longer want your baby's information to be included in the study, and it will not affect their medical care.

How to find out more

Andreas Stahl, Professor

andreas.stahl@med.uni-greifswald.de +49 3834 86 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.