Actively Recruiting

Phase Not Applicable
All Genders
ID07373821

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

Led by University Hospital Heidelberg · Updated on 2026-01-28

102

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This clinical trial studies people with Fuchs Endothelial Corneal Dystrophy undergoing Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. It aims to find out if spending more time lying on the back after surgery helps the corneal transplant stick better and reduces complications. Researchers also want to understand side effects like back pain from different durations of back positioning. Participants will be randomly assigned to one of two groups: lying on the back for 1 day or for 5 days after the transplant surgery. Both groups will wear a movement sensor to record head position. Researchers will regularly check participants' eyes using vision tests and anterior segment optical coherence tomography (AS-OCT) imaging. Participants will also answer questions about their vision and comfort and keep a diary of any back positioning-related complaints. During the first two weeks after surgery, researchers will measure the area of graft detachment to compare outcomes between groups. They will also monitor how many additional procedures, like rebubbling, are needed. Participants’ symptoms and comfort related to different back positioning durations will be assessed throughout the study. This trial is sponsored by University Hospital Heidelberg and plans to continue until March 2027.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Fuchs Endothelial Corneal Dystrophy Bullous Keratopathy
Not Eligible

You will not qualify if you...

  • Health conditions that prevent lying on the back after surgery

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - 1 to 5 days

Participants undergo Descemet Membrane Endothelial Keratoplasty (DMEK) surgery and receive assigned supine positioning for recovery.

1 surgery visit plus daily supine positioning

Post-operative Follow-up

Duration - 2 weeks

Participants are monitored for graft detachment and recovery over the first two weeks after surgery.

Approximately 3 to 4 follow-up visits

Trial Site Locations

Total: 1 location

1

Department of Ophthalmology, University Hospital Heidelberg

Heidelberg, Germany, 69120

Actively Recruiting

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Research Team

M

Maximilian Friedrich, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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