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

NCT07373821 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-01-28

No results posted yet for this 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

Conditions

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

Interventions

PROCEDURE

Duration of Supine Positioning

1 day supine positioning vs 5 days supine positioning

Sponsors & Collaborators

  • University Hospital Heidelberg

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-02
Primary Completion
2026-10-31
Completion
2027-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07373821 on ClinicalTrials.gov