RecruitingNAINTERVENTIONAL

Influence of Supine Positioning on the Outcomes After Descemet Membrane Endothelial Keratoplasty (DMEK)

This study is looking into the best way to recover after a specific eye operation called Descemet Membrane Endothelial Keratoplasty (DMEK). This surgery helps people with a condition called Fuchs' dystrophy. The main question is whether lying on your back for 5 days after surgery helps the new corneal tissue stay in place better compared to lying on your back for just 1 day. Researchers will also look at whether longer back-lying means fewer follow-up procedures are needed and what uncomfortable side effects, like back pain, might occur for participants in both groups. By understanding this, doctors hope to improve recovery and reduce further treatments for patients undergoing this eye surgery.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital Heidelberg

Enrolment target

102

Start

02 Oct 2025

Estimated completion

01 Mar 2027

Fuchs Endothelial Corneal Dystrophy Descemet Membrane Endothelial Keratoplasty (DMEK)

What is this study about?

This research is looking at an important part of recovery after a particular type of eye surgery called Descemet Membrane Endothelial Keratoplasty (DMEK). This operation is often done for people who have a condition called Fuchs Endothelial Corneal Dystrophy, which affects the clear front window of the eye (the cornea). During the surgery, a very thin layer of new tissue is put into the eye to help improve vision.

After DMEK surgery, it’s common for patients to be asked to lie on their back for a period. This is thought to help the new tissue stick correctly in place. However, the exact amount of time needed for this back-lying isn't clear, and spending a lot of time on your back can be uncomfortable or painful.

This study aims to figure out if lying on your back for 5 days is better for the success of the transplant than lying on your back for only 1 day. They also want to understand any discomfort or problems, such as back pain, that people might have with either approach. The results could help doctors give clearer instructions after surgery, making recovery more comfortable and effective for future patients.

Key takeaways

This study compares 1 day vs. 5 days of back-lying after DMEK eye surgery.
It aims to see if longer back-lying helps the new eye tissue stick better.
Researchers will also track side effects like back pain.
Participants will wear a head movement sensor and have regular eye checks.
The study is for people with Fuchs Endothelial Corneal Dystrophy undergoing DMEK.

Who may be eligible?

This study is looking for people who have a specific eye condition called Fuchs Endothelial Corneal Dystrophy, which is causing problems with their vision and making their cornea cloudy. You would need to be undergoing a DMEK eye surgery for this condition to be considered for the study.

It’s important that you are generally healthy enough to lie on your back for a period of time. If you have other health issues that would make lying on your back difficult or unsafe, you might not be able to join the study. The study is open to both men and women of all adult ages.

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 Fuchs Endothelial Corneal Dystrophy?
Am I having DMEK surgery?
Am I able to lie on my back for 1 to 5 days without major health problems?
Am I willing to be randomly placed into a group for recovery instructions?
Will I be able to attend follow-up appointments and keep a simple diary?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly placed into one of two groups. One group will be asked to lie on their back for 1 day after surgery, and the other group will be asked to lie on their back for 5 days. You won't get to choose which group you're in; it's decided by chance, like flipping a coin.

During your time in the study, you would wear a special sensor that records your head position to ensure you're following the instructions. You'll have regular eye check-ups, which include vision tests and special scans of your eye (called AS-OCT). You’ll also answer questions about your vision and how comfortable you feel. Additionally, you’ll keep a simple diary to note down any complaints related to your positioning, such as back pain. The total duration of your participation, including follow-up appointments, will be explained fully by the study team.

Potential risks and benefits

By taking part in this study, you could help doctors understand the best recovery methods after DMEK surgery, which might improve outcomes for future patients. There's also a chance that following the specific positioning instructions could help your own transplant heal better, although this is what the study aims to find out. Potential risks include discomfort or back pain from lying on your back, especially for the group asked to do so for 5 days. There's also the time commitment for appointments and wearing the sensor. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Department of Ophthalmology, University Hospital Heidelberg
Verified postcode
Heidelberg, Germany· Recruiting

Common questions

What is DMEK surgery?

DMEK is a type of eye surgery where a very thin, healthy layer of tissue is transplanted onto the clear front part of your eye (the cornea) to improve vision, often for conditions like Fuchs’ dystrophy.

Why do I need to lie on my back after the surgery?

Doctors believe lying on your back helps the newly transplanted tissue stick properly to your eye. This study is trying to find out the best amount of time to do this.

Are there other health problems that would stop me from joining?

Yes, if you have other health conditions that would make lying on your back difficult, unsafe, or particularly uncomfortable, you might not be able to participate.

What is 'rebubbling'?

Rebubbling is a follow-up procedure where a small air bubble is injected into the eye to help the transplanted tissue reattach if it hasn't stuck properly after the initial surgery.

Will I know which group I’m in?

Yes, once you are randomly assigned to either the 1-day or 5-day back-lying group, you will be informed so you can follow the instructions.

How to find out more

Maximilian Friedrich, MD

maximilian.friedrich@med.uni-heidelberg.de +49 6221 56 37749 Official trial record

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