Fuchs' Endothelial Dystrophy Clinical Trial
— BESTCorneaOfficial title:
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 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.
Status | Recruiting |
Enrollment | 220 |
Est. completion date | July 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | AZ Imelda | Bonheiden | |
Belgium | AZ Sint-Jan Brugge | Brugge | West-Vlaanderen |
Belgium | Erasmus ziekenhuis Brussel | Brussel | |
Belgium | UZ Brussel | Brussel | |
Belgium | AZ Monica (campus Deurne) | Deurne | |
Belgium | Antwerp University Hospital | Edegem | Antwerp |
Belgium | Ziekenhuis Oost-Limburg (ZOL) | Genk | |
Belgium | AZ Maria Middelares | Gent | Oost-Vlaanderen |
Belgium | UZ Gent | Gent | |
Belgium | UZ Leuven | Leuven | |
Belgium | CHU Liège | Liège |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Antwerp | Belgium Health Care Knowledge Centre |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | BCVA 12m | Best-corrected visual acuity expressed in LogMAR | 12 months | |
Secondary | BCVA 3 and 6m | Best-corrected visual acuity expressed in LogMAR | 3 and 6 months | |
Secondary | UCVA 3,6 and12m | Uncorrected visual acuity expressed in LogMAR | 3, 6 and 12 months | |
Secondary | Change in refraction | Change in objective refraction - spectacle correction | 3, 6 and 12 months | |
Secondary | Proportion of high vision | Proportion of patients to achieve 0.2 LogMAR visual acuity or less | 12 months | |
Secondary | EQ-5D-5L | Quality of life measured by the fifth level EuroQol (EQ-5L) instrument where five dimensions are scored at 5 levels - the higher the level, the worse the health state. The digits for the five dimensions can be combined to a 5-digit number to describe the patient's health state | 3, 6 and 12 months | |
Secondary | VFQ 25 | Vision related quality of life measured by the Visual Function Questionnaire(VFQ-25) scored on a scale of 0-100, with a higher score reporesenting higher quality of vision related quality of life. | 3, 6 and 12 months | |
Secondary | ECC | Endothelial cell count | 3, 6 and 12 months | |
Secondary | CCT | Central corneal thickness | 3, 6 and 12 months | |
Secondary | Complications | Complications associated with the intervention | 12 months |
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