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Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Comparison of treatment with preservative-free dexamethasone 0.1% (Monofree Dexamethason) and diclofenac 0.1% (Dicloabak) eye drops versus preserved dexamethasone 0.1% (Maxidex) and diclofenac 0.1% (Voltaren Ophtha) eye drops after cataract surgery.

This research is looking at eye drops used after cataract surgery. Cataracts are cloudy areas in the lens of the eye that can make your vision blurry. After surgery to remove a cataract, your eye needs to heal and inflammation needs to be managed. This study is comparing two types of eye drops: one set that doesn't contain preservatives and another set that does. We want to find out if the preservative-free drops are better at reducing swelling and irritation inside the eye, about a month after your operation. We'll also be checking for other things like how comfortable your eyes feel and how healthy the surface of your eye is.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
UZ Leuven
Enrolment target
100
Start
07 Nov 2024

What is this study about?

When you have cataract surgery, the cloudy lens in your eye is removed and replaced with a clear artificial one. After this operation, it's normal for your eye to be a bit inflamed and uncomfortable. Doctors often prescribe eye drops to help reduce this inflammation and pain, helping your eye to heal properly.

This particular study is focusing on comparing two different kinds of eye drops that contain similar medicines (dexamethasone and diclofenac). One type of drop includes preservatives, which are chemicals added to stop germs from growing in the bottle. The other type is preservative-free, meaning it doesn't contain these extra chemicals. Some people might find that preservatives can irritate their eyes, especially with long-term use, so researchers want to understand if preservative-free options are better after surgery.

The main goal of this study is to see if the preservative-free eye drops are superior to the eye drops with preservatives in reducing inflammation inside your eye four weeks after your cataract surgery. They will measure this by checking something called 'aqueous flare,' which is a way of seeing how much inflammation is present in the fluid inside your eye. They will also look at how comfortable your eyes are, how quickly they heal, and other factors related to eye health and comfort.

Key takeaways

  • This study compares preservative-free vs. preserved eye drops after cataract surgery.
  • It aims to find out which drops reduce inflammation better.
  • The main measurement is inflammation level in the eye at four weeks.
  • It's for anyone having cataract surgery, regardless of age or gender.
  • Your eye health would be closely monitored if you take part.

Who may be eligible?

This study is for anyone who is having cataract surgery, regardless of their age or gender. If you are preparing for or have recently had cataract surgery, you might be able to take part.

The doctors and researchers will need to check your medical history to make sure that taking part is safe and appropriate for you. They will explain all the details and answer any questions you have to help you decide if this study is right 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.

  1. Are you planning to have or have you recently had cataract surgery?
  2. Are you willing to use specific eye drops after your surgery?
  3. Are you able to attend follow-up appointments?
  4. Are you comfortable not knowing which type of eye drops you receive during the study?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given either preservative-free eye drops or eye drops with preservatives to use after your cataract surgery. You would use these drops as instructed by the study doctors. You would have several follow-up appointments, including one about four weeks after your surgery, where they will check your eye health and specifically measure the inflammation inside your eye (aqueous flare). Other checks might include how comfortable your eyes feel, your tear film, and the health of the front surface of your eye. The total duration of your participation would likely be several weeks, covering your post-surgery healing period.

Potential risks and benefits

Participating in this study might help improve our understanding of which eye drops are best after cataract surgery, potentially leading to better treatments for future patients. You would receive close monitoring of your eye health, but there's no guarantee that you will personally benefit. As with any medication, there's always a small risk of side effects from the eye drops, such as irritation or blurred vision, which you would be told about. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Belgium

Common questions

What is a cataract?

A cataract is when the natural lens inside your eye becomes cloudy, making your vision blurry or dim. It's often part of getting older.

What are eye drop preservatives?

Preservatives are chemicals added to some eye drops to stop bacteria and fungi from growing in the bottle after it's been opened, keeping the drops safe to use.

What is 'aqueous flare'?

'Aqueous flare' is a way doctors measure how much inflammation is in the fluid inside your eye. More flare means more inflammation.

Will I know which eye drops I'm using?

Often in studies like this, you won't know if you're getting the preservative-free or preserved drops until after the study is complete, to keep the results fair.

Do I have to pay to join the study?

No, you should not have to pay to participate in a clinical trial. All study-related care and medications are usually provided free of charge.

How to find out more

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

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