Comparing Two Corneal Transplant Methods for Corneal Endothelial Problems
Descemet Stripping Automated Endothelial Keratoplasty DSAEK versus Descemet Membrane Endothelial Keratoplasty DMEK
Led by University Hospital, Antwerp · Updated on 2026-04-03
220
Participants Needed
11
Research Sites
21 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are comparing two types of corneal transplant surgeries, Descemet Stripping Automated Endothelial Keratoplasty DSAEK and Descemet Membrane Endothelial Keratoplasty DMEK, for patients with corneal endothelial failure. The study aims to evaluate both clinical outcomes and patient-reported quality of life across various conditions causing endothelial dysfunction. This trial involves multiple centers in Belgium and seeks to address variability in how these surgeries are currently offered to patients.
Participants will be randomly assigned to receive either an ultra-thin DSAEK graft, which includes a thin layer of supporting tissue, or a DMEK graft that transplants only the endothelial layer with its membrane. Both grafts are prepared by specialized corneal banks. The surgeries involve precise techniques to remove diseased corneal tissue and insert the donor graft, with specific approaches for each type. Follow-up examinations occur at 3, 6, and 12 months after surgery.
Throughout the study, participants will undergo assessments of vision clarity, refraction, and corneal thickness, along with quality of life questionnaires like EQ-5D-5L and VFQ 25. Researchers will monitor complications and measure endothelial cell counts at each follow-up. The main outcome focuses on best-corrected visual acuity at 12 months. This comprehensive evaluation helps understand how each surgery impacts both eye health and patient experience over time.
CONDITIONS
Brief Title
The Belgian Endothelial Surgical Transplant of the Cornea
Research Team
V
Veerle Van Gerwen, BSc
A
Axelle Belis, BSc
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Diagnosis of Fuchs Endothelial Dystrophy, Bullous Keratopathy, or other causes of endothelial dysfunction including previous corneal graft failure
Pseudophakic (post cataract surgery) status
Age 18 years or older
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 proposed follow-up visits
Inclusion of the fellow eye in the study
Complex surgery combined with multiple eye diseases (e.g., glaucoma surgery)
Other contraindications to lamellar corneal surgery
Declined to participate
Under 18 years of age
Currently pregnant or breastfeeding
Phakic patients without planned cataract surgery
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery
Participants undergo one of two types of corneal endothelial transplant surgery: Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK) or Descemet Membrane Endothelial Keratoplasty (DMEK). This includes the surgical procedure and immediate care following surgery.
1 visit (in-person)
Post-operative Follow-up
Duration - 12 months
Participants are followed up post-surgery to monitor clinical outcomes and quality of life. Assessments include visual acuity, refraction, endothelial cell count, corneal thickness, and patient-reported outcomes.
Follow-up visits at 3, 6, and 12 months (in-person)
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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Published Research Related To This Trial
Belgian Endothelial Surgical Transplant of the Cornea (BEST cornea) protocol: clinical and patient-reported outcomes of Ultra-Thin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK) versus Descemet Membrane Endothelial Keratoplasty (DMEK) - a multicentric, randomised, parallel group pragmatic trial in corneal endothelial decompensation.
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