Active not recruitingNAINTERVENTIONAL

Visual Performance of Patients Implanted With a Multifocal IOL

This study is investigating a new type of lens called a multifocal intraocular lens (AT ELANA) for people undergoing cataract surgery or refractive lens exchange. The main goal is to understand how well people can see after getting these lenses and how satisfied they are with their vision. Participants will have the new lens implanted in both eyes. You'll have check-ups after the surgery and share your thoughts on your overall vision. The study aims to find out if this new lens improves sight and is a good option for people needing these eye-care procedures.

At a glance

Status

Active not recruiting

Phase

Sponsor

Carl Zeiss Meditec AG

Enrolment target

Start

31 Oct 2023

Estimated completion

01 Oct 2025

Cataract Refractive Lens Exchange

What is this study about?

When you have a cataract, the natural lens in your eye becomes cloudy, making your vision blurry. In cataract surgery, this cloudy lens is removed and replaced with a clear artificial one. Refractive lens exchange is a similar procedure where a clear lens is replaced to improve vision, often to reduce the need for glasses.

This study is looking at a specific new type of artificial lens called AT ELANA. It's a 'multifocal' lens, which means it’s designed to help you see clearly at different distances – far away, up close, and in between. The researchers want to know how well this new lens works for people having these eye operations. They are especially interested in how sharp people's vision is and how happy they are with their sight twelve months after surgery.

By taking part, you would receive this new lens in both eyes. The study will involve several visits where your vision will be tested, and you'll be asked about your experience and satisfaction with your new sight. The information gathered will help doctors understand if this multifocal lens is a good option for future patients.

Key takeaways

Tests a new type of lens (AT ELANA) for cataract or lens replacement surgery.
Aims to understand vision and patient happiness one year after surgery.
Involves having the new lens in both eyes.
Requires follow-up visits and questionnaires over 12 months.
For individuals 18+ with specific eye health and cataract conditions.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and planning to have cataract surgery or a lens replacement procedure in both eyes. There should be no more than 28 days between the two eye surgeries. You also need to have healthy eyes otherwise, meaning no other major eye problems that could affect your vision, apart from the cataract itself.

Your eye doctor will check if your cataracts are in a specific range and if your eye measurements, like the power of the lens needed and the curve of your eye (astigmatism), fit the study's requirements. Your vision should not be affected by other medical conditions or medicines.

You can't join if you have certain eye conditions like severe astigmatism (a common eye problem causing blurry vision), glaucoma (high pressure in the eye), or macular degeneration (an eye condition affecting central vision). Also, if you've had previous eye trauma, have problems with your pupils, or have difficulty attending follow-up appointments, you might not be able to participate.

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?
Are you scheduled for cataract surgery or refractive lens exchange in both eyes?
Do you have good overall eye health, apart from your cataract?
Is your eye doctor confident your 'astigmatism' (a common curve in the eye) is less than 1.0?
Are you able and willing to come for follow-up appointments?
Do you understand and agree to sign consent forms?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have the new AT ELANA lens implanted in both eyes during your planned cataract or lens replacement surgery. There will be a short time between the surgery on your first and second eye. After your operations, you'll need to attend several follow-up appointments over a period of twelve months. During these visits, your vision will be tested in various ways, and you'll be asked to complete questionnaires about your satisfaction with your new eyesight. You won't need to take any special medication specifically for the study. The total duration of your participation will be twelve months.

Potential risks and benefits

Participating in this study might offer you the potential benefit of receiving a new, potentially advanced multifocal lens designed to improve vision at various distances. However, as with any surgery, there are potential risks, including infection, swelling, or other complications related to eye surgery. The new lens itself might also have different visual outcomes compared to standard lenses, such as glare or halos around lights. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Universitätsklinikum Heidelberg
Verified postcode
Heidelberg, Germany
PVK Precise Vision GmbH
Verified postcode
Rheine, Germany
Ofatlivist Alicante
Verified postcode
Alicante, Spain

Common questions

What is a multifocal lens?

A multifocal lens is an artificial lens designed to help you see clearly at different distances, like close up, far away, and in between, potentially reducing your need for glasses.

Will I have this new lens in both eyes?

Yes, if you participate in this study, the new AT ELANA lens will be implanted in both of your eyes.

How long will I be involved in the study?

You will be part of the study for twelve months after your surgery, with several check-up appointments during that time.

Will I still need to wear glasses?

While multifocal lenses aim to reduce dependence on glasses, some people may still need them for certain tasks or conditions. The study is collecting information on how much people rely on glasses after surgery.

What if I change my mind about participating?

You can decide to leave the study at any point without it affecting your future medical care.