Clinical trial NCT05436665: The Belgian Endothelial Surgical Transplant of the Cornea
Official 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Corneal Edema
Corneal Endothelial Disorder
Fuchs' Endothelial Dystrophy
Bullous Keratopathy
Pseudophakic Bullous Keratopathy
Keywords: DMEK
DSAEK
UT-DSAEK
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Belgium Health Care Knowledge Centre
First posted: 2022-06-29
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After the patient has been screened and deemed eligible for participation, and the informed consent of the patient has been obtained, the patients will be included in the study. Once the inclusion data is entered by a member of the study personnel into the trial software, allocation of the patient to a treatment arm will take place using minimisation.

The allocation will be performed with an equal 1:1 allocation to DSAEK or DMEK with minimisation using the following stratification of participant factors:

* Surgical Indication (i.e., Fuchs' endothelial dystrophy and non Fuch's endothelial dystrophy);
* Surgical site;
* Preoperative visual acuity (Patients with 0.6 LogMAR BCVA or lower (i.e., better vision) and patients with LogMAR BCVA higher than 0.6 LogMAR (i.e., worse vision).

The minimisation will be performed by the study team using the online allocation software QMinim.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: BCVA 12m
timeFrame: 12 months
Secondary outcomes:
measure: BCVA 3 and 6m
timeFrame: 3 and 6 months
measure: UCVA 3,6 and12m
timeFrame: 3, 6 and 12 months
measure: Change in refraction
timeFrame: 3, 6 and 12 months
measure: Proportion of high vision
timeFrame: 12 months
measure: EQ-5D-5L
timeFrame: 3, 6 and 12 months
measure: VFQ 25
timeFrame: 3, 6 and 12 months
measure: ECC
timeFrame: 3, 6 and 12 months
measure: CCT
timeFrame: 3, 6 and 12 months
measure: Complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
city: Gent
country: Belgium
facility: AZ Maria Middelares
state: Oost-Vlaanderen
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge
state: West-Vlaanderen
city: Bonheiden
country: Belgium
facility: AZ Imelda
city: Brussel
country: Belgium
facility: Erasmus ziekenhuis Brussel
city: Brussel
country: Belgium
facility: UZ Brussel
city: Deurne
country: Belgium
facility: AZ Monica (campus Deurne)
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg (ZOL)
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHU Liège
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Sorcha Ni Dhubhghaill, MBBCh, PhD
role: STUDY_DIRECTOR
affiliation: University Hospital, Antwerp
name: Carina Koppen, MD, PhD
role: STUDY_CHAIR
affiliation: University Hospital Liege
name: Bernard Duchesne, MD, PhD
role: STUDY_CHAIR
References: