BEST CORNEA: eine pragmatische randomisierte Multicenter-Studie zum Vergleich der Descemet Stripping Automated Endothelial Keratoplasty mit der Descemet Membrane Endothelial Keratoplasty bei endothelialer Dekompensation der Hornhaut (KCE-201254)

Participants (P)

The target population is patients with endothelial decompensation, due to all causes. Due to the disease's nature, this is an elderly population.
Patients with all forms of endothelial decompensation:

• Fuchs Endothelial Dystrophy (FED);
• Bullous Keratopathy (BK);
• Other miscellaneous causes of endothelial dysfunction including  decompensation of a previous corneal graft and Iridocorneal endothelial syndrome;
• All patients must be pseudophakic for at least 6 weeks (post cataract surgery);
• Only one eye per patient will be deemed eligible for inclusion.

Intervention (I)

Descemet Membrane Endothelial Keratoplasty (DMEK) corneal transplantation where a thin (10-15um) transplant is used to replace the damaged endothelium. In our study, the graft will be prepared by a Belgian corneal bank in advance and will be implanted in participating surgical units

Control (C)

"Usual care" Descemet Stripping Automated Endothelial Keratoplasty (DSAEK), where a thicker graft (70-150um) is used to replace the damaged endothelium. In our study, the graft will be prepared by a Belgian corneal bank in advance and will be implanted in participating surgical units.

Outcome (O)

Change in Best-Corrected Visual Acuity (BCVA) measured in LogMAR units from baseline at 12 months.

Trial Design

A randomised, 1:1, multicentre, parallel group clinical trial

Sample Size

Trial duration

Budget

1,060,000 € 

Sponsor

Antwerp University Hospital (UZA)

Chief Investigator

Prof. Dr. Sorcha Ní Dhubhghaill

External Partners

Corneal Banks: CHU Liege and UZA prepare DSAEK and DMEK grafts UZ Gent and UZ Leuven observing and supporting

11 sites:

• Antwerp University Hospital 
• AZ Sint Jan Brugge 
• Maria Middelares Ziekenhuis 
• Universitair Ziekenhuis Leuven 
• UZ Brussels 
• Ziekenhuis Oost Limburg     
• University Hospital Liège 
• AZ Monica Hospital 
• Imelda Ziekenhuis Bonheiden
• Universitair Ziekenhuis Erasme
• Universitaire Ziekenhuis Gent