The Belgian Endothelial Surgical Transplant of the Cornea (NCT05436665) | Clinical Trial Compass
RecruitingNot Applicable
The Belgian Endothelial Surgical Transplant of the Cornea
Belgium220 participantsStarted 2022-08-10
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Fuchs Endothelial Dystrophy (FED);
* Bullous Keratopathy (BK);
* Other miscellaneous causes of endothelial dysfunction including decompensation of a previous corneal graft;
* Pseudophakic (post cataract surgery);
* Patients over 18 with the capacity to read and to understand the study information and to give informed consent, as well as study quality of life questionnaires;
* Patients willing and capable to attend the 3, 6, and 12-month follow-up appointments.
Exclusion Criteria:
* 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);
* Other contraindications to lamellar corneas surgery;
* Patients who elect not to participate;
* Patients under 18 years of age;
* Patients that are currently pregnant or breastfeeding;
* Phakic patients with no direct plan to perform cataract surgery.