Influence of Supine Positioning on the Outcomes After Descemet Membrane Endothelial Keratoplasty (DMEK)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity Hospital Heidelberg
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Duration of Supine Positioning
Procedure/Surgery1 day supine positioning vs 5 days supine positioning
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: 1 day supine positioningExperimental treatment 1 intervention
Group B: 5 day supine positioningActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Area of Graft Detachment in mm²
The area of graft detachment will be measured in mm² using anterior segment optical coherence tomography and a custom-built segmentation tool
Time frame
First two postoperative weeksSponsors and contacts
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Source ClinicalTrials.gov