Status:
RECRUITING
The Belgian Endothelial Surgical Transplant of the Cornea
Lead Sponsor:
University Hospital, Antwerp
Collaborating Sponsors:
Belgium Health Care Knowledge Centre
Conditions:
Corneal Edema
Corneal Endothelial Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 (D...
Detailed Description
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. Curr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT05436665
Start Date
August 10 2022
End Date
December 1 2027
Last Update
November 25 2025
Active Locations (11)
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1
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
2
AZ Maria Middelares
Ghent, Oost-Vlaanderen, Belgium
3
AZ Sint-Jan Brugge
Bruges, West-Vlaanderen, Belgium
4
AZ Imelda
Bonheiden, Belgium