Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Diagnosis of Fuchs Endothelial Corneal Dystrophy Bullous Keratopathy
You will not qualify if you...
- Health conditions that prevent lying on the back after surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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
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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