(20275) An extension study to evaluate the long-term outcomes of subjects who received treatment for retinopathy of prematurity in Study 20090
This research is a follow-up study for children who were treated for a serious eye condition called retinopathy of prematurity, or ROP. ROP affects babies born very early and can cause vision problems. This study aims to understand the long-term effects of the treatment and how these children are developing up to five years of age. Researchers will be looking closely at their vision, checking both eyes, to see how clear it is. They will also be monitoring for any eye problems or other health issues. In addition, the study includes tests to assess their overall development, making sure they are reaching important milestones as they grow. This helps doctors learn more about the best ways to care for babies with ROP.
At a glance
What is this study about?
This study is a follow-up for children who previously received treatment for an eye condition called retinopathy of prematurity (ROP). ROP is a disease that can affect babies who are born very prematurely, meaning many weeks before their due date. In ROP, abnormal blood vessels grow in the retina, which is the light-sensitive layer at the back of the eye. This can sometimes lead to serious vision problems or blindness if not treated.
The main purpose of this study is to see how children are doing in the long term, specifically up to five years of age, after receiving treatment for ROP. Doctors want to understand if the treatment they received had lasting positive effects on their vision and overall development. They will be measuring the children's eyesight and checking for any ongoing eye problems. They will also use standard tests to see if the children are developing normally.
By carefully checking these children over several years, doctors hope to gain a better understanding of how ROP and its treatments affect development and vision in the long run. This information can help improve how babies with ROP are cared for in the future, ensuring they receive the most effective treatments and support.
Key takeaways
- This is a follow-up study for children who had treatment for Retinopathy of Prematurity (ROP).
- It aims to check their vision and overall development up to age five.
- No new medication will be given; it's about monitoring long-term effects.
- Participation involves eye exams and developmental assessments.
- The information gathered will help improve future care for babies with ROP.
Who may be eligible?
This study is open to any child who previously received treatment during a specific earlier study (Study 20090) for retinopathy of prematurity (ROP). There are no restrictions based on a child's age or gender; if they participated in the previous treatment study, they may be able to join this follow-up.
The research team will have a full list of all the children who took part in the earlier treatment study. If your child was one of them, the study team will be able to check if they are suitable to participate in this long-term follow-up.
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.
- Did my child receive treatment for ROP in Study 20090?
- Is my child currently under 5 years old?
- Am I willing for my child to have regular eye checks?
- Am I willing for my child to have regular developmental assessments?
What does participation involve?
If your child takes part in this study, they will have regular check-ups and tests until they are 5 years old. These will include eye exams to check their eyesight and to look for any new or ongoing eye problems. They will not receive any new medication as part of this study; it's purely to observe their progress.
Children will also have special tests to assess their overall development, such as how they learn, play, and interact with others. These tests use well-known methods, like the Bayley Scales for infants and toddlers. The study will involve several visits over time, likely at ages 1, 2, 3, and 5 years old, to monitor these various aspects of their health and development. The total duration of participation depends on their current age and would last until their fifth birthday.
Potential risks and benefits
Locations (10)
- —UnverifiedSweden
- —UnverifiedItaly
- —UnverifiedPortugal
- —UnverifiedBulgaria
- —UnverifiedRomania
- —UnverifiedBelgium
- —UnverifiedCzechia
- —UnverifiedSpain
- —UnverifiedSlovakia
- —UnverifiedGreece
Common questions
What is Retinopathy of Prematurity (ROP)?
ROP is an eye condition that can affect babies born very early. It happens when abnormal blood vessels grow in the eye, which can sometimes lead to vision problems if not treated.
Will my child receive new treatment in this study?
No, this study is a follow-up to see how children are doing after the treatment they already received in a previous study. No new medication will be given as part of this research, but your child will continue to receive any standard medical care needed.
What kind of tests will my child have?
Your child will have regular eye exams to check their vision and eye health. They will also have special tests to look at their overall development, like how they are learning and growing.
How long will my child be in the study?
Your child will be in the study until they reach 5 years of age. The exact length depends on how old they are when they join the follow-up.
Can I take my child out of the study if I change my mind?
Yes, you can choose to withdraw your child from the study at any time, for any reason. This will not affect their regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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