Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty (SUPER-DMEK)

University Eye Hospital, Freiburg

Status: Completed

Conditions: Fuchs' Endothelial Dystrophy

Treatments: Behavioral: Supine positioning: 1 days; Behavioral: Supine positioning: 5 days

Study type: Interventional

Funder types: Other

Identifiers

NCT05399095

ETK 22-1101

Details and patient eligibility

About

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).

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of advanced Fuchs' endothelial corneal dystrophy (FECD)
• Indication for corneal endothelial transplantation (Descemet Membrane Endothelial Keratoplasty - DMEK)

Exclusion criteria

• Other corneal diseases (i.e. corneal scars, corneal dystrophies except FECD, corneal inflammation / infection)
• Regular use of drugs potentially affecting the cornea (i.e. amiodarone, chloroquine, triptan, isotretinoin, use of contact lenses in past four weeks, anesthetic eye drops)
• Diabetes mellitus with endorgan complications)
• Lack of fixation during corneal tomography
• Bedridden

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups

5 days supine positioning

Experimental group

Description:

Supine positioning for 5 days after DMEK with upright positioning for only 10 min every hour.

Treatment:

Behavioral: Supine positioning: 5 days

1 day supine positioning followed by usual physical activity for 4 days

Active Comparator group

Description:

Supine positioning for 1 days after DMEK with upright positioning for only 10 min every hour.

Treatment:

Behavioral: Supine positioning: 1 days