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

NCT07373821 | Recruiting

• 1 other identifier: S-400/2025
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

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

  First two postoperative weeks

Study Arms (2)

1 day supine positioning

EXPERIMENTAL

Procedure: Duration of Supine Positioning

5 day supine positioning

ACTIVE COMPARATOR

Procedure: Duration of Supine Positioning

Interventions

Duration of Supine Positioning PROCEDURE

1 day supine positioning vs 5 days supine positioning

1 day supine positioning; 5 day supine positioning

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Fuchs Endothelial Corneal Dystrophy Bullous Keratopathy

You may not qualify if:

• Comorbidities preventing supine positioning

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

Department of Ophthalmology, University Hospital Heidelberg

Heidelberg, 69120, Germany

RECRUITING

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Maximilian Friedrich, MD

CONTACT

+49 6221 56 37749; maximilian.friedrich@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: January 28, 2026
• Study Start: October 2, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)