NCT05399095

Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty

Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: University Eye Hospital, Freiburg · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial evaluates the efficacy and safety of postoperative supine head positioning on graft attachment after Descemet membrane endothelial keratoplasty in patients with Fuchs' endothelial corneal dystrophy (FECD).

Detailed description

In Descemet membrane endothelial keratoplasty (DMEK), an air or gas bubble is inserted in the anterior chamber of the eye to keep the ultrathin endothelial corneal graft attached to the patients own cornea. Supine positioning is thought to improve attachment by using the tamponade effect of the bubble. At present, it is unclear how long supine positioning is required. Positioning regimens vary between one hour to over one week. In this trial, the investigators will assess if prolonged supine positioning for 5 days improves graft attachment and long-term outcomes compared to supine positioning for 1 day.

Conditions

• Fuchs' Endothelial Dystrophy

Interventions

Type	Name	Description
BEHAVIORAL	Supine positioning: 5 days	Supine positioning for 5 days after DMEK
BEHAVIORAL	Supine positioning: 1 days	Supine positioning for 1 days after DMEK

Timeline

• Start date: 2022-05-23
• Primary completion: 2023-05-23
• Completion: 2023-05-23
• First posted: 2022-06-01
• Last updated: 2023-07-25

Locations

1 site across 1 country: Germany