Ongoing, recruitingTherapeutic use (Phase IV)Interventional

MyKid-study: efficacy and systemic side effects of intracameral Mydrane® injections in children undergoing cataract surgery.

This study, called 'MyKid-study', is investigating a specific injection called Mydrane. Children having cataract surgery will receive this injection directly into their eye. Cataracts are cloudy areas in the eye's lens that can blur vision. The main goal of the study is to see if Mydrane successfully makes the pupil (the black circle in the middle of your eye) wide enough for the surgeon to perform the operation easily, without needing other tools to hold it open. Researchers will also be checking for any effects on the child's heart rate and blood pressure. This is a Phase 4 study, meaning the treatment is already approved but researchers are gathering more information on its use. All children needing cataract surgery can potentially be included in this study.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Antwerp University Hospital

Enrolment target

Start

30 Jun 2023

pediatric cataract

What is this study about?

Cataracts can affect children, making their vision blurry. To remove a cataract, surgeons need to make the pupil – the black centre of your eye that lets light in – wide enough to work. Often, they use special tools to keep the pupil open during surgery. This study is looking at a medicine called Mydrane, which is given as an injection directly into the eye at the start of cataract surgery.

The main aim is to see if this Mydrane injection can make the pupil open wide enough on its own, so surgeons don't need those extra tools. This could potentially make the surgery smoother and perhaps reduce the time it takes. Researchers will carefully check how well Mydrane works to dilate the pupil and also keep an eye on how it affects children during surgery.

This is a 'Phase 4' study, which means Mydrane is already a medicine that doctors can use. However, this study specifically focuses on its use in children during cataract surgery to gather more information, particularly on its effectiveness and any effects it might have on the body, like changes in heart rate or blood pressure.

Key takeaways

This study explores a new way to widen the pupil during children's cataract surgery.
A medicine called Mydrane is injected directly into the eye at the start of surgery.
The main goal is to see if Mydrane helps avoid using extra tools to keep the pupil open.
Researchers will check heart rate and blood pressure during the surgery.
The study aims to gather more safety and effectiveness information for children.
Participation includes standard surgery and follow-up care.

Who may be eligible?

This study is open to all children who need to have cataract surgery. There are no specific age limits, meaning babies, younger children, and teenagers could all be considered.

Both boys and girls are welcome to take part in this study. The most important factor for joining is that a child has a cataract requiring surgical treatment.

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.

Is your child having cataract surgery?
Is your child of any age?
Is your child either a boy or a girl?

Answer every question to see your result.

What does participation involve?

If your child decides to take part in this study, the Mydrane injection would be given at the very start of their cataract surgery, into the eye that is being operated on. This is done during the surgery itself, so there wouldn't be extra hospital visits just for the injection.

During and immediately after the surgery, the medical team would carefully monitor your child's heart rate and blood pressure, as is standard for any surgery, but also specifically for this study. The doctors will also observe how well the pupil opens up during the operation. After the surgery, your child would have their usual follow-up appointments with their eye doctor, and these appointments would also be used to gather any necessary study information. The total duration of participation would align with the child's typical surgical and post-surgical care pathway.

Potential risks and benefits

Taking part in this study might offer the benefit of a potentially smoother surgical experience if Mydrane effectively dilates the pupil without needing additional devices. As with any medication and surgery, there are potential risks, though Mydrane is an approved medicine. Some possible effects could include changes in heart rate or blood pressure, which would be closely monitored. You are free to withdraw your child from the study at any time without giving a reason, and this will not affect their medical care.

Locations (1)

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

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Unverified
Belgium

Common questions

What is a cataract?

A cataract is when the normally clear lens inside the eye becomes cloudy, making vision blurry.

What is Mydrane?

Mydrane is a medicine given as an injection into the eye during surgery, designed to help widen the pupil.

Will my child have extra injections?

The Mydrane injection is given during the cataract surgery itself, so it's not an extra injection outside of the normal surgical process.

What does 'pupil dilatation' mean?

Pupil dilatation means making the dark circle in the middle of your eye (the pupil) larger, which helps the surgeon see better.

Will taking part change my child's usual care?

Participation is integrated into the existing cataract surgery and follow-up care. It aims to gather more information about safety and effectiveness during this specific procedure.