Not yet recruitingPHASE4INTERVENTIONAL

Toric Performance And Constant Evaluation

This study, called "Toric Performance And Constant Evaluation," is designed to understand more about a specific type of lens used during cataract surgery. This lens, called a monofocal toric IOL, is for people who have cataracts and also a common eye problem called astigmatism. We are checking how safe and effective this lens is. The main goal is to improve the way doctors calculate the exact power of this lens, so patients get the best possible vision after their cataract operation. This is important to make sure the lens works as well as it can for people needing this type of surgery.

At a glance

Status

Not yet recruiting

Phase

PHASE4

Sponsor

Carl Zeiss Meditec AG

Enrolment target

130

Start

01 May 2026

Estimated completion

28 Feb 2028

Cataract

What is this study about?

Imagine your eye like a camera, and the lens inside it helps focus light so you can see clearly. Sometimes, this natural lens gets cloudy, which is called a cataract. When this happens, surgery can replace the cloudy lens with a new, clear artificial one. This particular study is about a special type of artificial lens called a 'monofocal toric IOL'.

This special lens is designed for people who have both cataracts and another common eye problem called astigmatism. Astigmatism means the front surface of your eye (the cornea) isn't perfectly round, which can make your vision blurry or distorted at all distances. The 'toric' part of the lens helps correct this astigmatism at the same time as removing the cataract.

The main aim of this study is to closely watch how well this special lens works in real patients and to make sure it's safe. Specifically, researchers want to fine-tune how doctors choose the power of these lenses for different people. By getting these measurements and calculations just right, eye doctors can help even more people achieve clearer vision after their cataract surgery. This type of research helps improve cataract treatment for everyone.

Key takeaways

Tests a special lens for cataracts and astigmatism.
Aims to improve vision after surgery.
Aims to refine lens calculation methods.
Participation includes regular eye check-ups.
Designed for people with both cataracts and astigmatism.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a cataract that needs surgery. You must also have a common eye condition called astigmatism (where the front of your eye isn't perfectly round) that is at least a certain level. It's important that you can come to all the eye check-ups planned for the study.

There are also some reasons why you might not be able to join. For example, if you've already had eye surgery that could affect the results, or if you have certain other serious eye conditions. People who are pregnant or breastfeeding, or who have irregular astigmatism, also can't take part. The study also can't include you if you've recently been part of another medical study.

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 18 years old or older?
Do you have a cataract that needs surgery?
Do you have common astigmatism in at least one eye?
Can you attend all required eye appointments?
Have you not had previous eye surgery that might affect results?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the clinic for eye examinations both before and after your cataract surgery. Your doctor will perform the surgery to replace your cloudy eye lens with the special study lens. These visits will help the doctors check how well the new lens is working and how your vision is improving. You won't be given any extra medication for this study, as it focuses on the lens itself. The total duration of your participation, including all follow-up appointments, will be explained fully by the study team.

Potential risks and benefits

Taking part in this study may offer a potential benefit if the special lens used helps to improve both your cataract and astigmatism, possibly leading to clearer vision. However, as with any surgery, there are potential risks associated with cataract surgery, such as infection or other complications, although these are rare. The study is designed to assess the safety and performance of the lens. You are free to withdraw from the study at any time without affecting your standard medical care.

Locations (6)

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

Oční klinikaO
Verified postcode
Prague, Czechia
Oční Centrum Praha
Verified postcode
Prague, Czechia
Ústřední vojenská nemocnice - Vojenská fakultní nemocnice Praha
Verified postcode
Prague, Czechia
Universitätsklinikum Heidelberg
Verified postcode
Heidelberg, Germany
Ofatlivist Alicante
Verified postcode
Alicante, Spain
Ayrshire Eye Clinic
Verified postcode
Ayr, United Kingdom

Common questions

What is a 'monofocal toric IOL'?

It's a special artificial lens used in cataract surgery that corrects both cataracts and a common eye problem called astigmatism.

What is astigmatism?

Astigmatism is when the front surface of your eye (the cornea) isn't perfectly round, causing blurry or distorted vision.

Who can join this study?

You need to be over 18, have a cataract needing surgery, and also have a certain level of astigmatism in at least one eye.

What will happen if I join?

You'll have regular eye check-ups before and after your cataract surgery, which will use the study lens. Your vision will be monitored.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without it affecting your usual medical care or treatment.

How to find out more

Grant Sharpe

grant.sharpe@zeiss.com +447918937014 Official trial record

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