The Belgian Endothelial Surgical Transplant of the Cornea

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Antwerp

About this trial

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.

Eligibility criteria

Qualifiers

Fuchs Endothelial Dystrophy (FED);

Bullous Keratopathy (BK);

Other miscellaneous causes of endothelial dysfunction including decompensation of a previous corneal graft;

Pseudophakic (post cataract surgery);

Disqualifiers

Inability to provide informed consent;

Patients unable to attend the proposed follow up;

Inclusion of the fellow eye in the study;

Complex surgery combined with multiple pathologies (i.e., glaucoma surgery);

Trial design

Treatments tested in this trial

  • UT-DSAEK
  • DMEK

Treatment groups

220 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Antwerp

Lead sponsor

Belgium Health Care Knowledge Centre

Collaborator