RecruitingNAINTERVENTIONAL

Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy

This study compares two types of surgery for people who have both cataracts and a specific eye condition called Fuchs' endothelial corneal dystrophy. One group of patients will have cataract surgery only. The other group will have cataract surgery combined with a special type of corneal transplant, called Triple-DMEK. This transplant involves replacing damaged cells at the back of the cornea. Researchers want to see if combining these two surgeries (Triple-DMEK) leads to better vision than cataract surgery alone. They will also look at other aspects of vision, eye health, and how the surgery affects a person's quality of life. The goal is to find the best way to help people with these conditions see more clearly.

At a glance

Status

Recruiting

Phase

Sponsor

University of Cologne

Enrolment target

120

Start

24 Jan 2025

Estimated completion

01 Jun 2026

Cataract Surgery Cataract and Fuchs Endothelial Corneal Dystrophy

What is this study about?

If you have both a cataract and an eye condition called Fuchs' endothelial corneal dystrophy, this study might be of interest to you. A cataract is like a cloudy lens in your eye that blurs your vision. Fuchs' dystrophy affects the very thin, inner layer of your cornea (the clear front part of your eye), which can also make your vision foggy or hazy, especially in the mornings, though in this study, people with morning fogginess that makes their vision worse are not included.

This study is looking at two ways to improve vision for people with both these conditions. One option is just to have cataract surgery, which replaces the cloudy lens with a new clear one. The other option is to have cataract surgery combined with a procedure called Triple-DMEK. Triple-DMEK is a type of corneal transplant where only the very thin, damaged inner layer of your cornea is replaced with a healthy donor layer. The aim is to see if adding this special corneal transplant (Triple-DMEK) makes a bigger difference to your vision and overall eye health compared to having only cataract surgery.

The main goal of the study is to compare how well people can see after each type of surgery. But the researchers will also be looking at other important things, like how the surgeries affect your day-to-day vision, the health of your eyes, and your general quality of life. They want to understand which approach offers the best outcomes for patients.

Key takeaways

Compares two surgical approaches for cataract and Fuchs' dystrophy.
One group gets cataract surgery, other gets cataract surgery plus corneal transplant (Triple-DMEK).
Main goal is to see which surgery improves vision more.
Also examines other vision factors, quality of life, and safety.
Participation involves eye exams, questionnaires, and follow-up after surgery.

Who may be eligible?

To join this study, you need to be at least 18 years old and have both a cataract and Fuchs' endothelial corneal dystrophy in the eye being studied. Your cataract should be moderate, and your Fuchs' dystrophy should be at a certain stage without noticeable swelling of the cornea. You also need to understand and be able to read English, and provide your written agreement to take part.

There are several reasons why someone might not be able to join. For example, if you have other eye problems or health conditions that could affect your vision, or if you've had certain eye surgeries or injuries before. Your pupil also needs to widen enough for the surgery, and your eye can't have certain features like a very shallow front chamber.

Pregnant or breastfeeding women, as well as women under 60 who are pregnant, cannot participate. You also can't be taking certain medications or be involved in other medical studies at the same time. If you meet these general requirements, the study team will do specific checks to see 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.

Are you at least 18 years old?
Do you have both a cataract and Fuchs' endothelial corneal dystrophy?
Can you read and understand English?
Are you able to agree to take part in the study in writing?
Are you not pregnant or breastfeeding, and not pregnant if you are under 60?
Do you have any other serious eye or health conditions that aren't expected to clear up?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening appointment. This involves a thorough eye check-up, including looking at the front and back of your eye, measuring your eye pressure and vision, and taking special scans of your eye. If you're a woman under 60, you'll also need a pregnancy test. If you meet all the criteria, you'll officially join the study.

Before your surgery, you'll have a 'baseline' visit, where more tests are done, including specific photos of your cornea and questionnaires about your vision and quality of life. You'll then be randomly assigned to one of the two surgery groups – either cataract surgery alone or cataract surgery combined with the special corneal transplant (Triple-DMEK). This means you won't get to choose which surgery you have.

After your surgery, you'll have regular follow-up appointments with your eye doctor, just like you would with standard care. There will also be a specific follow-up visit about 22 weeks (roughly 5 months) after your surgery to check your progress and conduct more tests.

Potential risks and benefits

Taking part in this study may offer the potential benefit of improved vision and a better understanding of which surgery is most effective for your condition. However, as with any surgery, there are potential risks, such as infection, bleeding, or other complications. The specific risks for each surgery will be fully explained by your doctor. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Department of Ophthalmology, Aarhus University Hospital
Verified postcode
Aarhus N, Denmark· Not yet recruiting
Klinik für Ophthalmologie des Universitätsklinikums Köln
Verified postcode
Cologne, Germany· Recruiting
Radboud-Universität Nijmegen
Verified postcode
Nijmegen, Netherlands· Not yet recruiting
Instituto de microcirugía ocular; Departamento de Cornea y Cirugia Refractiva
Verified postcode
Barcelona, Spain· Not yet recruiting

Common questions

What is Fuchs' endothelial corneal dystrophy?

It's an inherited eye condition where the cells at the very back of the cornea (the clear front window of your eye) gradually become unhealthy. This can lead to corneal swelling and hazy vision.

What is Triple-DMEK surgery?

Triple-DMEK is a combined surgery that involves removing a cloudy cataract and, at the same time, transplanting a very thin, healthy layer of corneal tissue to replace the damaged layer affected by Fuchs' dystrophy.

Will I get to choose which surgery I have?

No, you won't choose. You'll be randomly assigned to either receive cataract surgery alone or the combined Triple-DMEK surgery. This is done to ensure the study results are fair and unbiased.

How long will I be in the study?

After your surgery, you'll have standard post-operative care, and then a specific follow-up study visit about 22 weeks (around 5 months) later.

What is the main thing the study wants to find out?

The study primarily aims to see if combining cataract surgery with the special corneal transplant (Triple-DMEK) leads to better vision for patients compared to just having cataract surgery alone.

How to find out more

Björn Bachmann, Prof.

bjoern.bachmann@uk-koeln.de 0049-221 478-87476 Official trial record

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