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

University Hospital Heidelberg

Status: Enrolling

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

Treatments: Procedure: Duration of Supine Positioning

Study type: Interventional

Funder types: Other

Identifiers

NCT07373821

S-400/2025

Details and patient eligibility

About

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

Enrollment: 102 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Fuchs Endothelial Corneal Dystrophy Bullous Keratopathy

Exclusion criteria

Comorbidities preventing supine positioning

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 2 patient groups

1 day supine positioning

Experimental group

Treatment:

Procedure: Duration of Supine Positioning

5 day supine positioning

Active Comparator group

Treatment:

Procedure: Duration of Supine Positioning