Comparing two surgical methods for corneal endothelial disorders
The Belgian Endothelial Surgical Transplant of the Cornea:Clinical and Patient-reported Outcomes of Descemet Stripping Automated Endothelial Keratoplasty(DSAEK) Versus Descemet Membrane Endothelial Keratoplasty(DMEK)
This study is testing which of two eye surgeries, DSAEK or DMEK, works better for people with corneal problems and how satisfied they are with the results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 11 sites (Edegem, Antwerp and 10 other locations) |
| Trial ID | NCT05436665 on ClinicalTrials.gov |
What this trial studies
This study is a randomized multicentric trial comparing Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) and Descemet Membrane Endothelial Keratoplasty (DMEK) for patients with corneal endothelial decompensation. A total of 220 patients will be recruited from 11 surgical centers in Belgium and randomly assigned to receive either DSAEK or DMEK. The study will assess clinical outcomes, such as best-corrected visual acuity, and patient-reported outcomes using quality of life assessment tools at 3, 6, and 12 months post-surgery. The aim is to determine the effectiveness and patient satisfaction associated with each surgical option.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with Fuchs Endothelial Dystrophy, Bullous Keratopathy, or other causes of endothelial dysfunction who can provide informed consent.
Not a fit: Patients under 18, those unable to provide informed consent, or individuals with complex surgical needs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidance on the most effective surgical approach for treating corneal endothelial disorders, improving patient outcomes.
How similar studies have performed: Previous studies have shown varying success with DSAEK and DMEK, but this study aims to provide a direct comparison in a pragmatic setting, making it a valuable addition to existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Edegem, Antwerp and 10 other locations
- Antwerp University Hospital — Edegem, Antwerp, Belgium (Recruiting)
- AZ Maria Middelares — Ghent, Oost-Vlaanderen, Belgium (Recruiting)
- AZ Sint-Jan Brugge — Bruges, West-Vlaanderen, Belgium (Recruiting)
- AZ Imelda — Bonheiden, Belgium (Recruiting)
- Erasmus ziekenhuis Brussel — Brussels, Belgium (Recruiting)
- UZ Brussel — Brussels, Belgium (Recruiting)
- AZ Monica (campus Deurne) — Deurne, Belgium (Recruiting)
- Ziekenhuis Oost-Limburg (ZOL) — Genk, Belgium (Recruiting)
- UZ Gent — Ghent, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- CHU Liège — Liège, Belgium (Recruiting)
Study contacts
- Study coordinator: Veerle Van Gerwen, BSc
- Email: bestcornea@uza.be
- Phone: +3238210000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.