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Recruiting NCT07373821

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

No phase Interventional Fuchs Endothelial Corneal Dystrophy Descemet Membrane Endothelial Keratoplasty (DMEK)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Duration of Supine Positioning.
Who it may be relevant to
Registry conditions: Fuchs Endothelial Corneal Dystrophy, Descemet Membrane Endothelial Keratoplasty (DMEK). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Procedure Duration of Supine Positioning
    1 day supine positioning vs 5 days supine positioning

Primary outcome measures

  • Area of Graft Detachment in mm² [Time frame: First two postoperative weeks]

Eligibility criteria

Inclusion criteria

Fuchs Endothelial Corneal Dystrophy Bullous Keratopathy

Exclusion criteria

Comorbidities preventing supine positioning

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Department of Ophthalmology, University Hospital Heidelberg — Heidelberg

Identifiers

NCT: NCT07373821 · S-400/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗