The Belgian Endothelial Surgical Transplant of the Cornea

Last updated: January 10, 2025
Sponsor: University Hospital, Antwerp
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

DSAEK

DMEK

UT-DSAEK

Clinical Study ID

NCT05436665
UZAntwerpen
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Fuchs Endothelial Dystrophy (FED);

  • Bullous Keratopathy (BK);

  • Other miscellaneous causes of endothelial dysfunction including decompensation of aprevious corneal graft;

  • Pseudophakic (post cataract surgery);

  • Patients over 18 with the capacity to read and to understand the study informationand 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-upappointments.

Exclusion

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

Total Participants: 220
Treatment Group(s): 3
Primary Treatment: DSAEK
Phase:
Study Start date:
August 10, 2022
Estimated Completion Date:
July 01, 2026

Study 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.

Connect with a study center

  • Antwerp University Hospital

    Edegem, Antwerp 2650
    Belgium

    Active - Recruiting

  • AZ Maria Middelares

    Gent, Oost-Vlaanderen
    Belgium

    Active - Recruiting

  • AZ Sint-Jan Brugge

    Brugge, West-Vlaanderen
    Belgium

    Active - Recruiting

  • AZ Imelda

    Bonheiden,
    Belgium

    Active - Recruiting

  • Erasmus ziekenhuis Brussel

    Brussel,
    Belgium

    Active - Recruiting

  • UZ Brussel

    Brussel,
    Belgium

    Active - Recruiting

  • AZ Monica (campus Deurne)

    Deurne,
    Belgium

    Active - Recruiting

  • Ziekenhuis Oost-Limburg (ZOL)

    Genk,
    Belgium

    Active - Recruiting

  • UZ Gent

    Gent,
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven,
    Belgium

    Active - Recruiting

  • CHU Liège

    Liège,
    Belgium

    Active - Recruiting

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