Actively Recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
Led by University Hospital, Antwerp · Updated on 2026-04-03
220
Participants Needed
11
Research Sites
303 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Antwerp
Lead Sponsor
B
Belgium Health Care Knowledge Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Belgian Endothelial Surgical Transplant of the Cornea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Fuchs Endothelial Dystrophy, Bullous Keratopathy, or other endothelial dysfunction including graft decompensation
- Pseudophakic (post cataract surgery) patients
- Age over 18 years
- Ability to read, understand study information, and provide informed consent
- Willingness and ability to attend follow-up visits at 3, 6, and 12 months
You will not qualify if you...
- Unable to provide informed consent
- Unable to attend scheduled follow-ups
- Inclusion of the fellow eye in the study
- Complex surgery with multiple eye conditions (e.g., glaucoma surgery)
- Contraindications to lamellar corneal surgery
- Declined participation
- Under 18 years of age
- Currently pregnant or breastfeeding
- Phakic patients without planned cataract surgery
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
2
AZ Maria Middelares
Ghent, Oost-Vlaanderen, Belgium
Actively Recruiting
3
AZ Sint-Jan Brugge
Bruges, West-Vlaanderen, Belgium
Actively Recruiting
4
AZ Imelda
Bonheiden, Belgium
Actively Recruiting
5
Erasmus ziekenhuis Brussel
Brussels, Belgium
Actively Recruiting
6
UZ Brussel
Brussels, Belgium
Actively Recruiting
7
AZ Monica (campus Deurne)
Deurne, Belgium
Actively Recruiting
8
Ziekenhuis Oost-Limburg (ZOL)
Genk, Belgium
Actively Recruiting
9
UZ Gent
Ghent, Belgium
Actively Recruiting
10
UZ Leuven
Leuven, Belgium
Actively Recruiting
11
CHU Liège
Liège, Belgium
Actively Recruiting
Research Team
V
Veerle Van Gerwen, BSc
CONTACT
A
Axelle Belis, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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