ClinicalTrials.gg
Sign In
RecruitingNCT07373821SUPINEUpdated Jan 28, 2026

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

An interventional study of Duration of Supine Positioning in Fuchs Endothelial Corneal Dystrophy and Descemet Membrane Endothelial Keratoplasty (DMEK), sponsored by University Hospital Heidelberg. Recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2026-01-28.

Sponsored by University Hospital Heidelberg · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Sex
All
01

Study summary

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
02

Conditions studied

  • Fuchs Endothelial Corneal Dystrophy
  • Descemet Membrane Endothelial Keratoplasty (DMEK)
03

In context

Fuchs' Endothelial Dystrophy

92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 27 are open to participants now.

This study's planned enrollment of 102 is above the median of 50 across 62 interventional studies indexed under Fuchs' Endothelial Dystrophy.

Browse Fuchs' Endothelial Dystrophy studies →

Lead sponsor

University Hospital Heidelberg is the lead sponsor of 177 studies on the registry; 48 are open to participants now.

Browse University Hospital Heidelberg studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Fuchs Endothelial Corneal Dystrophy Bullous Keratopathy

Exclusion criteria

Exclusion Criteria:

Comorbidities preventing supine positioning

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
102 participants (estimated)

Study arms

  • Experimental
    1 day supine positioning

    Procedure: Duration of Supine Positioning

  • Active comparator
    5 day supine positioning

    Procedure: Duration of Supine Positioning

Interventions

  • ProcedureDuration of Supine Positioning

    1 day supine positioning vs 5 days supine positioning

06

What researchers measure

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 weeks

07

Study locations

1 of 1 sites recruiting
  • Department of Ophthalmology, University Hospital Heidelberg
    Heidelberg, 69120, Germany
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07373821
Lead sponsor
University Hospital Heidelberg
Responsible party
Maximilian Friedrich (Principal Investigator, University Hospital Heidelberg) — Principal investigator
First posted
Jan 28, 2026
Start date
Oct 2, 2025
Primary completion
Oct 2026 (estimated)
Completion
Mar 2027 (estimated)
Last update
Jan 28, 2026

Study contacts

Maximilian Friedrich, MD
Contact
maximilian.friedrich@med.uni-heidelberg.de
+49 6221 56 37749

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Fuchs' Endothelial Dystrophy →

Other studies from this sponsor

University Hospital Heidelberg →

Start the discussion