RecruitingInterventional

Treatment of retinal detachment in people who have not had cataract surgery and are not very short-sighted with either vitrectomy surgery alone or with vitrectomy and removal of the cataract at the same time

This study is about finding the best way to treat a detached retina, which is a serious eye condition that can affect your vision. If your retina, the light-sensitive layer at the back of your eye, comes away from its normal position, you'll need an operation. The most common operation is called a vitrectomy. Sometimes, this surgery can lead to cataracts, making your vision cloudy. Researchers want to know if it's better to: 1) have only the vitrectomy, and deal with cataracts later if they come up, or 2) have both the vitrectomy and cataract surgery done in one go. The study will compare how well both options work, looking at things like your vision, how healthy your retina stays, and your overall satisfaction. It aims to help doctors decide the best approach for future patients.

At a glance

Status

Recruiting

Sponsor

Queen's University Belfast

Enrolment target

276

Start

09 May 2025

Estimated completion

30 Apr 2027

Rhegmatogenous retinal detachment

What is this study about?

Imagine the back of your eye has a special layer called the retina, which is like the film in a camera. It sees the world and sends messages to your brain so you can see. Sometimes, this delicate layer can come loose, or ‘detach’, from the back of your eye. This is called a rhegmatogenous retinal detachment (RRD), and it can make your vision blurry or even cause you to lose sight if not treated quickly.

The main surgery to fix a detached retina is called a vitrectomy. During this operation, the surgeon removes a jelly-like substance from the middle of your eye to help reattach the retina. A common side effect of this surgery is that it can make you more likely to develop cataracts, which are cloudy areas in the eye's natural lens that blur your vision. If you get a cataract, you might need another operation later to replace the cloudy lens with a clear artificial one.

Doctors are currently unsure whether it's better to do the vitrectomy on its own, and then treat any cataracts later if they develop, or if it's better to do both the vitrectomy and the cataract surgery at the same time. This study, called COMBAT, aims to answer this important question. By comparing these two approaches, researchers hope to find out which one leads to better vision, fewer problems, and happier patients overall. The results will help doctors make the best decisions for people needing treatment for a detached retina in the future.

Key takeaways

This study compares two ways to fix a detached retina.
It checks if having cataract surgery at the same time as retina surgery is better than having it separately.
Participants will be aged 50 or over, without very strong glasses for short-sightedness or existing cataracts.
You will be assigned to a treatment group by chance.
The study aims to improve treatments for future patients with a detached retina.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 50 years or older who have a detached retina. You should not have had cataract surgery before, and you shouldn't be very short-sighted (meaning your glasses prescription is not stronger than minus 6, or your eyeball is not overly long).

Also, you can join if you haven't had previous surgery on the inside of your eye (vitreoretinal surgery) and your doctor has already decided you need a vitrectomy for your detached retina.

However, you can't join if you already have a very noticeable cataract that covers your central vision, or if you've already had your natural eye lens replaced with an artificial one. You also can't take part if you are very short-sighted, have a very large tear in your retina, or if you're already in another study involving a new medicine.

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 50 years old or older?
Do you have a detached retina that needs surgery?
Have you not had previous cataract surgery?
Are you not very short-sighted (e.g., your glasses prescription is less than -6)?
Have you not had other eye surgery inside your eye before?
Do you not have a very noticeable cataract already?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first meet with the study team and your surgeon to discuss everything and make sure you understand. After you give your permission, you'll be assigned by chance (like flipping a coin) to one of two groups. One group will have the standard vitrectomy surgery to fix your detached retina. If you develop cataracts later, you'll have a separate surgery for those. The other group will have both the vitrectomy for your retina and cataract surgery at the same time.

After your surgery, the study team will keep track of your vision, how well your retina stays attached, any problems you might have, and your satisfaction with the outcome. This will involve regular check-ups at the hospital. The study will run until October 2028, and your participation will involve follow-up appointments over a period of time, though the exact number of visits will depend on your individual recovery and the group you are in.

Potential risks and benefits

Taking part in this study offers potential benefits, as it could lead to better vision and help us understand the safest and most effective way to treat a detached retina for yourself and future patients. You might also receive closer monitoring of your eye health. However, like all surgeries, both vitrectomy and cataract surgery carry risks, such as infection, bleeding, or other complications, though these are rare. If you decide to join, you can withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (32)

Belfast Health and Social Care Trust
City only
Belfast, Northern Ireland
Barts Health NHS Trust
City only
London, England
Bradford Teaching Hospitals NHS Foundation Trust
City only
Bradford, England
Guys and St Thomas' NHS Foundation Trust
City only
London, England
Kings College Hospital
Approximate
London, England
Liverpool University Hospitals NHS Foundation Trust
Unverified
Liverpool, England
Buckinghamshire Healthcare NHS Trust
Unverified
Amersham, England
County Durham and Darlington NHS Foundation Trust
Unverified
Darlington, England
Hull University Teaching Hospitals NHS Trust
Unverified
Hull, England
Manchester University NHS Foundation Trust
Unverified
Manchester, England
Moorfields Eye Hospital NHS Foundation Trust
Unverified
London, England
Oxford University Hospitals NHS Foundation Trust
Unverified
Oxford, England

Common questions

What is a detached retina?

A detached retina is when the special seeing-layer at the back of your eye comes loose from its normal position, which can blur your vision or make you lose sight if not treated.

What is a vitrectomy?

A vitrectomy is an eye surgery where a jelly-like substance is removed from inside your eye to help reattach your retina when it's detached.

What is a cataract?

A cataract is a common eye condition where the natural lens inside your eye becomes cloudy, making your vision blurry or misty.

Will I get to choose which surgery I have?

No, if you join the study, you'll be randomly assigned to one of the two surgery groups, like drawing lots, to make sure the study results are fair and unbiased.

Who is paying for this study?

Queen's University Belfast in the UK is providing the funding for this research study.

How to find out more

Colette Jackson

colette.jackson@nictu.hscni.net - Official trial record

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