The Belgian Endothelial Surgical Transplant of the Cornea

Not Applicable

Recruiting

• Conditions: Fuchs' Endothelial Dystrophy; Bullous Keratopathy; Corneal Edema; Pseudophakic Bullous Keratopathy; Corneal Endothelial Disorder
• Interventions: Procedure: DSAEK; Procedure: DMEK

• Registration Number: NCT05436665
• Lead Sponsor: University Hospital, Antwerp

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 (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.

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. Currently the type of corneal graft that a patient receives depends on the treating surgeon opinions.

In this study 220 patients in 11 surgical centres will be recruited and allocated to one of the two surgical options. Both the Ultrathin DSAEK and DMEK grafts will be prepared by corneal banks in the University Hospital of Liege and University Hospital of Antwerp respectively. Patients will be examined preoperatively and postoperatively at 3, 6 and 12 months. Clinical information such as best-corrected visual acuity and refraction will be collected as well as quality of life information based on the EQ-5D-5L and the VFQ 25 assessment tools. These data be used to compare the interventions both on the clinical level as well as from the patient perspective.

Study Timeline

• Study First Submitted: 2022-06-23
• Study First Submitted QC: 2022-06-23
• Study First Posted: 2022-06-29
• Study Start: 2022-08-10
• Status Verified: 2024-06
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-14
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UT-DSAEK	DSAEK	Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK) refers to the use of a corneal endothelial/Descemet graft with a thin layer of stroma (\<110um) attached. The cornea is made up of 5 layers, all of which work to provide a clear image on the retina. The innermost layer of cells, the endothelium, is responsible for pumping fluid out of the cornea and keeping it transparent: a normal endothelium is essential to keeping the cornea clear. The endothelium lies on a membrane called the Descemet membrane. The thickest layer of the cornea is called the stroma and this provides rigidity and strength to the cornea. When the corneal endothelium fails, it cannot regrow and the best treatment is to replace the cells with healthy donor cells. This is called a corneal endothelial transplantation or endothelial keratoplasty. In the DSAEK technique, a piece of the donor's endothelium is transplanted with a supporting layer of donor stroma.
DMEK	DMEK	Descemet membrane endothelial keratoplasty refers to the use of a corneal endothelial/Descemet graft with no layer of associated stroma (15-20um thick). The cornea is made up of 5 layers, all of which work to provide a clear image on the retina. The innermost layer of cells, the endothelium, is responsible for pumping fluid out of the cornea and keeping it transparent: a normal endothelium is essential to keeping the cornea clear. The endothelium lies on a membrane called the Descemet membrane. The thickest layer of the cornea is called the stroma and this provides rigidity and strength to the cornea. When the corneal endothelium fails, it cannot regrow and the best treatment is to replace the cells with healthy donor cells. This is called a corneal endothelial transplantation or endothelial keratoplasty. In the DMEK technique only a piece of donor endothelium layer is together with its supporting membrane (the Descemet membrane), is transplanted.

Primary Outcome Measures

Name	Time	Method
BCVA 12m	12 months	Best-corrected visual acuity expressed in LogMAR

Secondary Outcome Measures

Name	Time	Method
BCVA 3 and 6m	3 and 6 months	Best-corrected visual acuity expressed in LogMAR
VFQ 25	3, 6 and 12 months	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.
ECC	3, 6 and 12 months	Endothelial cell count
Complications	12 months	Complications associated with the intervention
UCVA 3,6 and12m	3, 6 and 12 months	Uncorrected visual acuity expressed in LogMAR
Proportion of high vision	12 months	Proportion of patients to achieve 0.2 LogMAR visual acuity or less
CCT	3, 6 and 12 months	Central corneal thickness
Change in refraction	3, 6 and 12 months	Change in objective refraction - spectacle correction
EQ-5D-5L	3, 6 and 12 months	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

Trial Locations

Locations (11)

UZ Gent; 🇧🇪 Gent, Belgium

Ziekenhuis Oost-Limburg (ZOL); 🇧🇪 Genk, Belgium

AZ Monica (campus Deurne); 🇧🇪 Deurne, Belgium

CHU Liège; 🇧🇪 Liège, Belgium

AZ Imelda; 🇧🇪 Bonheiden, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

Antwerp University Hospital; 🇧🇪 Edegem, Antwerp, Belgium

UZ Brussel; 🇧🇪 Brussel, Belgium

AZ Maria Middelares; 🇧🇪 Gent, Oost-Vlaanderen, Belgium

AZ Sint-Jan Brugge; 🇧🇪 Brugge, West-Vlaanderen, Belgium

Erasmus ziekenhuis Brussel; 🇧🇪 Brussel, Belgium