Loading clinical trials...
Loading clinical trials...
The Belgian Endothelial Surgical Transplant of the Cornea:Clinical and Patient-reported Outcomes of Descemet Stripping Automated Endothelial Keratoplasty(DSAEK) Versus Descemet Membrane Endothelial Keratoplasty(DMEK)
This study is designed as a randomised multicentric parallel group pragmatic trial of Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) versus Descemet Membrane Endothelial Keratoplasty (DMEK) in corneal endothelial decompensation. the purpose is to compare the clinical and patient reported outcomes of both therapies across a broad range of indications.
The current problem concerns variability in the provision of corneal endothelial keratoplasties available to patients in Belgium. Some patients receive DSAEK and some (albeit fewer) receive DMEK. Currently the type of corneal graft that a patient receives depends on the treating surgeon opinions. In this study 220 patients in 11 surgical centres will be recruited and allocated to one of the two surgical options. Both the Ultrathin DSAEK and DMEK grafts will be prepared by corneal banks in the University Hospital of Liege and University Hospital of Antwerp respectively. Patients will be examined preoperatively and postoperatively at 3, 6 and 12 months. Clinical information such as best-corrected visual acuity and refraction will be collected as well as quality of life information based on the EQ-5D-5L and the VFQ 25 assessment tools. These data be used to compare the interventions both on the clinical level as well as from the patient perspective.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Antwerp University Hospital
Edegem, Antwerp, Belgium
AZ Maria Middelares
Ghent, Oost-Vlaanderen, Belgium
AZ Sint-Jan Brugge
Bruges, West-Vlaanderen, Belgium
AZ Imelda
Bonheiden, Belgium
Erasmus ziekenhuis Brussel
Brussels, Belgium
UZ Brussel
Brussels, Belgium
AZ Monica (campus Deurne)
Deurne, Belgium
Ziekenhuis Oost-Limburg (ZOL)
Genk, Belgium
UZ Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Start Date
August 10, 2022
Primary Completion Date
March 1, 2027
Completion Date
December 1, 2027
Last Updated
November 25, 2025
220
ESTIMATED participants
UT-DSAEK
PROCEDURE
DMEK
PROCEDURE
Lead Sponsor
University Hospital, Antwerp
Collaborators
NCT02118922
NCT06983652
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions