RecruitingNAINTERVENTIONAL

Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation

This study is investigating a new tool called the Tran cannula, which is a special irrigation system designed for cleaning the eye during surgery. It's for people who have a specific type of glaucoma called pseudoexfoliative glaucoma, which often makes cataract surgery more complicated. The study aims to compare how effective the Tran cannula is at lowering eye pressure after surgery, compared to a common method called 'augmented irrigation.' Researchers want to find out if using this new tool can lead to better outcomes for patients having cataract surgery who also have this type of glaucoma, by helping to reduce the eye pressure which is a key part of managing glaucoma.

At a glance

Status

Recruiting

Phase

Sponsor

Hôpital Privé de la Baie

Enrolment target

Start

04 Jun 2025

Estimated completion

02 Feb 2029

Glaucoma, Open Angle, Pseudo-exfoliative Cataract

What is this study about?

This study is looking into a new way to help people who have a combination of two eye problems: cataracts and a specific type of glaucoma called pseudoexfoliative glaucoma. Glaucoma is a condition where the pressure inside the eye becomes too high, which can damage the nerve connecting your eye to your brain and affect your vision. Pseudoexfoliative glaucoma happens when tiny, flaky material builds up in the eye, which can block the natural drainage system and raise eye pressure. People with this type of glaucoma often find cataract surgery a bit more challenging, and there can be a higher risk of complications.

The study's main goal is to test a new tool called the Tran cannula. This is a special, single-use system designed to wash the eye during cataract surgery, specifically to help clear out any of that flaky material that might be blocking the eye's drainage. The researchers want to see if using this Tran cannula helps to lower eye pressure more effectively after surgery, compared to simply increasing the amount of fluid used during a standard wash (which they call 'augmented irrigation').

Essentially, the study wants to find out if this new cleaning method can improve the results of cataract surgery for people with pseudoexfoliative glaucoma, by making sure their eye pressure is well-controlled afterwards. Finding better ways to manage eye pressure during and after surgery is very important for protecting vision in people with glaucoma.

Key takeaways

This study is for people with both a cataract and pseudoexfoliative glaucoma.
It tests a new washing tool (Tran cannula) during cataract surgery.
The goal is to see if it helps lower eye pressure better than standard methods.
Controlling eye pressure is key to managing glaucoma and protecting vision.
Participation involves surgery and follow-up visits.
You have the right to stop participating at any time.

Who may be eligible?

To join this study, you would need to have both a cataract and an early to medium stage of pseudoexfoliative glaucoma. Your eye pressure should be higher than normal but not extremely high, and an eye specialist would need to confirm that your glaucoma is causing changes to your vision and the nerve at the back of your eye. You also need to have clear signs of pseudoexfoliation (the flaky material) in your eye.

There are several reasons why someone might not be able to join. For example, if you have other serious eye conditions besides your cataract or mild dry eye, or if you've had eye surgery or laser treatment in the past year. Also, if your eyesight is very poor, if you have very high or very low shortsightedness or longsightedness, or if your eye pressure can't be measured accurately due to other eye issues, you wouldn't be able to participate. Having certain serious health conditions unrelated to your eyes might also prevent you from joining.

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.

Do I have a cataract and also pseudoexfoliative glaucoma?
Is my glaucoma considered early to moderate?
Has my eye pressure been between 21 and 33 mmHg before any treatment?
Have I avoided eye surgery or laser treatment in the last 12 months?
Do I have no other serious eye conditions apart from my cataract or mild dry eye?
Do I have no major health problems that could affect my participation?

Answer every question to see your result.

What does participation involve?

The details of taking part aren't fully described here, but generally, in studies like this, you would have an initial visit to check if you meet all the requirements. If you do, you would then have your cataract surgery where the Tran cannula or augmented irrigation method would be used. After the surgery, you would likely have several follow-up appointments over a period of time to check your eye pressure, vision, and overall eye health. These visits would involve eye exams and possibly more specific tests to see how well the treatment is working and to monitor for any side effects. The total length of your participation would depend on how long the researchers need to follow your progress.

Potential risks and benefits

Participating in this study could potentially offer the benefit of receiving a new, potentially more effective treatment method (the Tran cannula) during your cataract surgery, which might lead to better control of your eye pressure. However, as with any surgery or new procedure, there are always potential risks, such as infection, bleeding, or other surgical complications. The study will carefully monitor for any side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Hôpital Privé de la Baie
Verified postcode
Avranches, France· Recruiting
Fondation Rothschild
Verified postcode
Paris, France· Recruiting
Clinique de la Côte d'Emeraude
Verified postcode
St-Malo, France· Not yet recruiting

Common questions

What is pseudoexfoliative glaucoma?

It's a type of glaucoma where tiny flaky material builds up in the eye, which can block fluid drainage and increase eye pressure, potentially harming your vision.

What is a Tran cannula?

It's a new, single-use tool designed to wash and clean the eye during cataract surgery, especially to clear out the flaky material seen in pseudoexfoliative glaucoma.

Why is this study important for people with cataracts and glaucoma?

Cataract surgery can be more complicated in people with this type of glaucoma. This study hopes to find a better way to do the surgery and control eye pressure afterwards, which is important for protecting your vision.

Will I know which treatment I receive?

The information provided doesn't specify, but often in such studies, you might not know if you're receiving the new treatment or the standard comparison to ensure unbiased results. This is called 'blinding'.

What does 'augmented irrigation' mean?

It means using a bit more fluid than usual to wash the eye during surgery. It's the standard comparison method in this study.

How to find out more

Ana Miguel, MD

myworld_ana@hotmail.com +33 7 87 01 61 87 Official trial record

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