Status:

COMPLETED

Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty

Lead Sponsor:

University Eye Hospital, Freiburg

Conditions:

Fuchs' Endothelial Dystrophy

Eligibility:

All Genders

18-100 years

Phase:

NA

Brief 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'...

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 c...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

May 23 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 23 2023

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT05399095

Start Date

May 23 2022

End Date

May 23 2023

Last Update

July 25 2023

Active Locations (1)

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Medical Center - University of Freiburg, Eye Hospital

Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106