Lying on your back after DMEK: 1 day versus 5 days
Influence of Supine Positioning on the Outcomes After Descemet Membrane Endothelial Keratoplasty (DMEK)
This trial sees if lying on your back for five days after DMEK surgery helps the transplant stick better than lying on your back for one day for people with Fuchs endothelial corneal dystrophy or corneal failure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Sex | All |
| Sponsor | University Hospital Heidelberg Academic / other |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT07373821 on ClinicalTrials.gov |
What this trial studies
This randomized trial assigns patients who receive Descemet membrane endothelial keratoplasty (DMEK) to lie supine for either 1 day or 5 days after surgery to compare graft attachment and the need for additional procedures. Participants wear a movement sensor that records head position to measure adherence and undergo regular vision tests and anterior-segment OCT imaging to quantify any detachment. Patients also complete symptom questionnaires, keep a diary of comfort and issues, and report any adverse events such as back pain. Primary outcomes include detachment size and rebubbling rates, with safety and tolerability as secondary outcomes.
Who should consider this trial
Good fit: Adults with Fuchs endothelial corneal dystrophy or bullous keratopathy scheduled for DMEK who can tolerate lying on their back are the ideal candidates.
Not a fit: People who cannot lie flat because of back, respiratory, or cardiac conditions, or those with other eye diseases that affect graft outcomes, may not receive benefit from this positioning approach.
Why it matters
Potential benefit: If successful, longer supine positioning could reduce graft detachment and lower the need for rebubbling after DMEK.
How similar studies have performed: Previous case series and small trials suggest supine positioning helps graft attachment, but the optimal duration is unclear and randomized data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Fuchs Endothelial Corneal Dystrophy Bullous Keratopathy Exclusion Criteria: Comorbidities preventing supine positioning
Where this trial is running
Heidelberg
- Department of Ophthalmology, University Hospital Heidelberg — Heidelberg, Germany (Recruiting)
Study contacts
- Study coordinator: Maximilian Friedrich, MD
- Email: maximilian.friedrich@med.uni-heidelberg.de
- Phone: +49 6221 56 37749
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.