Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM
This study looks at a common eye problem called epiretinal membrane, or ERM. This is a thin layer that grows over the retina at the back of the eye and can make your vision blurry or distorted. Many people have surgery to remove it, but doctors are often unsure whether it's best to operate straight away or to wait and see if vision gets worse over time. This research aims to understand if delaying surgery makes a difference to how well you see afterwards. We also want to find out what factors might predict who gets better after surgery and who might get worse if they wait. Lastly, we're testing new ways to measure vision distortion, which is a common symptom of ERM.
At a glance
What is this study about?
Imagine the back of your eye has a delicate film, like cling film, growing over it. This is called an epiretinal membrane, or ERM. It can make straight lines look wavy, or your vision a bit blurry. Surgery to remove this film is very common, and it's usually successful in improving vision.
However, doctors often face a dilemma: should they operate as soon as an ERM is found, especially if your vision is still quite good? Or is it better to wait until your vision gets worse? Some believe waiting might lead to a less good outcome in the long run because the membrane is still affecting the eye. On the other hand, avoiding surgery when it's not immediately necessary also has its benefits. This study wants to get to the bottom of this by comparing people who have surgery right away with those who wait.
We also want to understand who benefits most from surgery and who might be able to wait without their vision getting significantly worse. This will help doctors make clearer recommendations in the future. Furthermore, this study will explore new ways to measure how much distortion people experience, as this is a common problem with ERM, and we want to see if these new tests can help us understand the condition better.
Key takeaways
- The study compares early surgery versus waiting for an eye condition called ERM.
- It aims to find the best time for surgery to get the best vision results.
- Researchers also want to predict who will benefit most from treatment.
- New ways to measure vision distortion are being tested.
- Participation involves regular eye check-ups and potentially surgery.
Who may be eligible?
To join this study, you need to be aged 45 or older. Your vision should still be reasonably good, but your doctor believes the ERM is causing your symptoms, which could be blurry vision or distortion, and that these symptoms have appeared or worsened in the last two years. The ERM itself needs to be affecting the central part of your vision, and your doctor thinks you don't need immediate surgery, meaning you and your doctor are happy to wait at least four weeks before having an operation.
There are also reasons why you might not be able to join. For example, if you have certain other eye conditions like a history of problems with blood vessels in your eye, or if you've had previous eye surgery (apart from standard cataract removal more than three months ago). Also, if your ERM is caused by another specific eye problem, or if you have an active serious eye condition like a retinal tear or a macular hole, you likely won't be eligible. The study will carefully check your medical history to ensure it's safe for you to participate.
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 45 years old or older?
- Is your vision still fairly good (e.g., you can read many letters on an eye chart)?
- Does your doctor think an ERM is causing your blurry or distorted vision?
- Are you able to wait at least 4 weeks for surgery if advised?
- Have you not had certain other serious eye conditions or surgeries (besides standard cataract removal)?
- Are you generally healthy enough for eye surgery?
What does participation involve?
Information about what taking part involves is not detailed in the provided summary. Typically, clinical trials like this would involve: regular eye examinations with specialist equipment (like OCT scans), vision tests (including tests for distortion and reading speed), and discussions with the study doctor and nurses. If you are in the 'immediate surgery' group, you would have your operation soon after joining. If you are in the 'deferred surgery' group, you would be monitored regularly and might have surgery later if your vision worsens. Follow-up appointments would be scheduled over a period to track your vision and eye health. The total duration of participation and specific visit schedules would be explained in full detail by the research team.
Potential risks and benefits
Locations (46)
- Mayo Clinic ArizonaVerified postcodeScottsdale, United States· Recruiting
- Kent W. Small, MD, AMCVerified postcodeGlendale, United States· Recruiting
- Salehi Retina Institute Inc.Verified postcodeHuntington Beach, United States· Recruiting
- Loma Linda UniversityVerified postcodeLoma Linda, United States· Recruiting
- Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc.Verified postcodeMountain View, United States· Recruiting
- East Bay Retina Consultants, Inc.Verified postcodeOakland, United States· Recruiting
- Regents of the University of California, Davis, DBA University of California, DavisVerified postcodeSacramento, United States· Recruiting
- Macula Retina Vitreous InstituteVerified postcodeTorrance, United States· Recruiting
- Florida Retina Institute, James A. Staman, MD, PA- JacksonvilleVerified postcodeJacksonville, United States· Recruiting
- Sarasota Retina InstituteVerified postcodeSarasota, United States· Recruiting
- SEASHORE RETINA LLC DBA Retina Specialists of TampaVerified postcodeWesley Chapel, United States· Recruiting
- Southeast Retina Center, P.C.Verified postcodeAugusta, United States· Recruiting
Common questions
What is an epiretinal membrane (ERM)?
It's a thin layer of tissue that grows over the retina at the back of your eye, which can make your vision blurry or distorted.
Will I definitely have surgery if I join this study?
No, you might be in a group that has surgery straight away, or a group that waits to see if surgery becomes necessary later. Everyone will be monitored closely.
What does 'deferred surgery' mean?
It means waiting to have surgery. Doctors and you would decide to watch your eye condition and only do surgery if your vision gets worse.
Are there any alternative treatments to surgery?
For epiretinal membranes, surgery is currently the only known way to remove the membrane and improve vision. This study explores the best timing for this surgery.
Will I get to choose which group I'm in?
This is a 'randomised' study, meaning you would be put into one of the groups by chance, like flipping a coin. This helps make the study fair.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.