All studies
RecruitingPHASE3INTERVENTIONAL

Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal

This study, called COMBAT, is looking into the best way to treat a condition called rhegmatogenous retinal detachment (RRD), where the light-sensitive layer at the back of your eye comes away. RRD can cause vision loss and needs surgery. Many people who have RRD surgery (vitrectomy) later develop cataracts, which also need surgery. The study wants to find out if it's better to: 1) have the retina surgery first and then, if needed, cataract surgery later; or 2) have both the retina surgery and cataract surgery at the same time. Researchers will compare how well people see, how often their retina reattaches successfully, their quality of life, and any complications. This will help doctors understand the most effective approach for people aged 50 and over who have a detached retina and haven't had cataract surgery before.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Queen's University, Belfast
Enrolment target
276
Start
16 May 2025
Estimated completion
08 May 2028

What is this study about?

Imagine the back of your eye like the film in a camera – that's your retina, and it's essential for seeing clearly. Sometimes, this delicate layer can come loose, a condition doctors call rhegmatogenous retinal detachment (RRD). This can cause serious vision loss and almost always needs an operation to fix it.

The most common surgery for a detached retina is called a vitrectomy. However, after this surgery, many people develop cataracts, which is when the natural lens inside your eye becomes cloudy, making your vision blurry. If this happens, you often need another operation to remove the cataract and replace it with a clear artificial lens.

At the moment, doctors aren't sure if it's better to do the retina surgery and cataract removal as two separate operations, or if it's better to do both operations at the same time. The COMBAT study aims to answer this important question. By comparing these two approaches, the study hopes to find out which one leads to better vision, fewer complications, and a better overall experience for patients.

Key takeaways

  • The study compares two ways to treat a detached retina in people who haven't had cataract surgery.
  • It aims to find out if it's better to have retina surgery alone, or retina surgery plus cataract removal at the same time.
  • Participants will be aged 50 or over and have a detached retina needing surgery.
  • The study will look at vision, success of retina reattachment, quality of life, and safety.
  • This research could help improve future treatments for detached retinas.
  • You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To be considered for this study, you need to be an adult aged 50 or older. You should have a detached retina (rhegmatogenous retinal detachment) and be planning to have retina surgery (pars plana vitrectomy) to fix it. It's important that you haven't had cataract surgery before, and your short-sightedness should not be very severe.

There are also some reasons you wouldn't be able to join. For instance, if you already have a very advanced cataract that significantly affects your vision, or if you've already had surgery on the gel in your eye (vitreoretinal surgery), you wouldn't be eligible. Also, if your detached retina is due to a very large tear or a specific type of tear called a retinal dialysis, you wouldn't be able to take part.

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.

  1. Are you 50 years old or older?
  2. Do you have a detached retina that needs surgery?
  3. Have you never had cataract surgery before?
  4. Is your short-sightedness not extremely high?
  5. Do you *not* have a very advanced or visually significant cataract right now?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups, like flipping a coin. One group will have the standard retina surgery first. If you develop a cataract later that needs removing, you would have separate cataract surgery. The other group will have both the retina surgery and cataract removal done together in one operation.

Throughout the study, doctors will check your vision, look at how well your retina has reattached, and ask about your quality of life and how satisfied you are with your vision. They will also keep an eye on any complications, if you need any extra surgeries, and track the costs involved. The study will involve regular follow-up visits and assessments after your surgery to see how you are recovering and how your vision is improving. The exact number and timing of these visits will be explained by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is contributing to valuable knowledge that could improve future care for people with detached retinas. Depending on which group you are in, you might have fewer surgeries overall if both procedures are done at once, or avoid an unnecessary cataract surgery if your lens remains clear after retina repair alone. Potential risks are generally linked to the surgeries themselves, such as infection, bleeding, or other complications, which your surgeon will explain in detail. You are free to withdraw from the study at any time without affecting your medical care.

Locations (27)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Buckinghamshire Healthcare NHS Trust
    Verified postcode
    Aylesbury, United Kingdom· Recruiting
  • Belfast Health and Social Care Trust
    Verified postcode
    Belfast, United Kingdom· Not yet recruiting
  • Sandwell and West Birmingham Hospitals NHS Trust
    Verified postcode
    Birmingham, United Kingdom· Not yet recruiting
  • Bradford Teaching Hospitals NHS Foundation Trust
    Verified postcode
    Bradford, United Kingdom· Not yet recruiting
  • University Hospitals Bristol NHS Foundation Trust
    Verified postcode
    Bristol, United Kingdom· Not yet recruiting
  • County Durham and Darlington NHS Foundation Trust
    Verified postcode
    Darlington, United Kingdom· Not yet recruiting
  • NHS Greater Glasgow & Clyde
    Verified postcode
    Glasgow, United Kingdom· Not yet recruiting
  • Hull University Teaching Hospitals NHS Trust
    Verified postcode
    Hull, United Kingdom· Not yet recruiting
  • The Leeds Teaching Hospitals NHS Trust
    Verified postcode
    Leeds, United Kingdom· Not yet recruiting
  • University Hospitals Leicester NHS Trust
    Verified postcode
    Leicester, United Kingdom· Not yet recruiting
  • Liverpool University Hospitals NHS Foundation Trust
    Verified postcode
    Liverpool, United Kingdom· Not yet recruiting
  • Barts Health NHS Trust
    Verified postcode
    London, United Kingdom· Not yet recruiting

Common questions

What is a detached retina?

It's when the light-sensitive layer at the back of your eye comes away from its normal position, which can cause blurry vision or vision loss.

What is a cataract?

A cataract is when the clear lens inside your eye becomes cloudy, making your vision fuzzy, especially in older age.

What is 'randomly assigned'?

It means you'll be put into one of the treatment groups by chance, like drawing lots, to ensure the study is fair and unbiased.

Will I know which treatment I'm getting?

Yes, you will know if you are having one surgery or both surgeries at the same time.

Can I choose which treatment group I'm in?

No, if you join the study, the treatment group you are in will be decided randomly.

How to find out more

Colette Jackson

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

Interested in taking part?

Register your interest

Share your details and the research team for "Treatment of Retinal Detachment in People Who Have Not Had C…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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