Department of Ophthalmology, University Hospital Heidelberg
Heidelberg, 69120, Germany
Location status: Recruiting
NCT Number: NCT07373821
The goal of this clinical trial is to learn if a longer period of lying on the back after corneal transplant surgery (Descemet Membrane Endothelial Keratoplasty, DMEK) helps the transplant stick better in the eye. It will also learn about side effects, such as back pain.
The main questions it aims to answer are:
* Does lying on the back for 5 days reduce the size of transplant detachment compared to lying on the back for only 1 day? * Do participants who lie on their back longer need fewer additional procedures (rebubbling)? * What symptoms or problems do participants experience with short vs. long back positioning?
Researchers will compare two groups:
* 1 day of back positioning * 5 days of back positioning
Participants will:
* Be randomly assigned to one of the two positioning groups * Wear a movement sensor that records head position * Have their eyes checked regularly with vision tests and imaging (AS-OCT) * Answer questions about their vision and comfort * Keep a diary of any positioning-related complaints, such as back pain
Interested in participating?
Request InfoAll sexes
Interventional
Not applicable
Heidelberg, 69120, Germany
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Fuchs Endothelial Corneal Dystrophy Bullous Keratopathy
Exclusion criteria
Comorbidities preventing supine positioning
1 day supine positioning vs 5 days supine positioning
Time frame: First two postoperative weeks
The area of graft detachment will be measured in mm² using anterior segment optical coherence tomography and a custom-built segmentation tool
Contact information is provided by the study sponsor or research team.
University Hospital Heidelberg
Other
Acronym: SUPINE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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