Robotic RVO Trial: Robot-assisted Retinal Vein Cannulation in Patients With Retinal Vein Occlusions
This study is investigating a new treatment for Retinal Vein Occlusion (RVO), a common cause of lasting vision loss in the UK. Current treatments help manage the problem but don't fix the blocked blood vessel itself. This trial uses a special robot to very precisely inject a clot-dissolving medicine, called tPA, directly into the tiny blocked vein in the eye. The goal is to clear the blockage and restore normal blood flow, which could lead to better vision. We are comparing this new robotic treatment combined with standard care against standard care alone. The robot helps make the injection very steady and accurate. If successful, this could offer a new way to help people with RVO. Forty people with RVO will take part.
At a glance
What is this study about?
Retinal Vein Occlusion (RVO) is an eye condition where a small blood vessel (a vein) in the back of your eye gets blocked, much like a tiny stroke in the eye. This blockage stops blood from flowing properly, which can damage your vision. It's a common cause of sight loss in the UK.
Currently, treatments mainly focus on dealing with the problems caused by the blockage, like swelling at the back of the eye. However, these treatments don't actually clear the blockage itself. This study is exploring a new approach: using a special medicine called tPA (which dissolves blood clots) and injecting it directly into the blocked vein. Because these veins are very small and delicate, a special robot is used to make sure the injection is incredibly precise and steady. The aim is to dissolve the clot, clear the blockage, and help restore blood flow to your eye.
This study will compare people who receive the new robot-assisted treatment (along with the usual care) with those who only receive the usual care. Doctors will carefully monitor everyone for 12 months to see how safe the new treatment is and how well it helps improve vision and the health of the eye. If this new method works well, it could become a significant new treatment option for people with RVO.
Key takeaways
- This study explores a new robotic method to treat RVO by directly dissolving blood clots.
- The treatment involves a robot-assisted injection of clot-dissolving medicine (tPA) into the eye.
- It aims to improve vision by clearing the blocked vein, not just managing symptoms.
- Participation lasts 12 months and involves regular eye check-ups.
- The study compares the new treatment with standard care for RVO.
- Your safety and potential benefits are carefully considered during the trial.
Who may be eligible?
To be considered for this study, you would need to be 18 years old or older and have been recently diagnosed with a central Retinal Vein Occlusion (RVO) within the last four weeks. Your doctor will also need to confirm that you are generally well enough for eye surgery and able to follow all the study's instructions. Your vision in the affected eye would need to be below a certain level (like 6/12 or worse) to qualify.
There are some reasons why you might not be able to join. For example, if you have other serious eye conditions, or health problems that would make eye surgery risky (like uncontrollable shaking), or if you're allergic to certain dyes used in eye tests. Also, if you're already taking part in another research study that involves a new treatment or surgery, or if you have certain health issues or are on medications that don't mix well with the clot-dissolving medicine (tPA), then this study might not be suitable for you.
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.
- Are you 18 years old or older?
- Have you been diagnosed with central RVO in the last 4 weeks?
- Is your vision in the affected eye 6/12 or worse?
- Are you able and willing to attend all study appointments for 12 months?
- Do you have any other eye conditions or health issues that might prevent surgery?
What does participation involve?
If you decide to take part, you'll be randomly assigned to one of two groups: either you'll receive the usual care for RVO, or you'll receive the usual care plus the new robot-assisted injection of clot-dissolving medicine. The specific number of visits and assessments will be explained by the study team, but you can expect regular check-ups. You'll be carefully monitored for 12 months to see how you're doing. This will involve eye examinations, tests to check your vision, and other assessments to monitor the health of your eye.
Potential risks and benefits
Locations (1)
- Eye Research Group Oxford, Oxford Eye Hospital, LG1, West Wing of the John Radcliffe HospitalVerified postcodeOxford, United Kingdom
Common questions
What is Retinal Vein Occlusion (RVO)?
It's an eye condition where a blood vessel in the back of your eye gets blocked, causing vision problems.
What is tPA?
tPA is a medicine that helps dissolve blood clots. It's used in this study to try and clear the blocked vein in the eye.
Why use a robot?
The robot helps make the injection of tPA very precise and steady, which is important because the veins in your eye are tiny and delicate.
How long will the study last?
Participants will be monitored for 12 months after the treatment.
Will I definitely get the new treatment?
No, participants are randomly assigned to either receive the new treatment plus standard care, or just standard 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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