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

January 23, 2026 updated by: Maximilian Friedrich, University Hospital Heidelberg

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Fuchs Endothelial Corneal Dystrophy Bullous Keratopathy

Exclusion Criteria:

Comorbidities preventing supine positioning

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 day supine positioning
Procedure: Duration of Supine Positioning
1 day supine positioning vs 5 days supine positioning
Active Comparator: 5 day supine positioning
Procedure: Duration of Supine Positioning
1 day supine positioning vs 5 days supine positioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area of Graft Detachment in mm²
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
First two postoperative weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Heidelberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

October 2, 2025

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-400/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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