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)

Overview

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.

Interventions

• Procedure UT-DSAEK
  The main incision (3.5-5mm) is created at the corneal limbus or via a cornea-scleral tunnel with 2-3 smaller (approx. 1mm) paracentesis incisions. An ophthalmic viscosurgical device (OVD) or a continuous infusion of water or air can be used to maintain the stability of the anterior chamber, according to the surgeon's preference. The corneal endothelium is scored using a scoring instrument and the central diseased corneal endothelium is removed. Once the anterior chamber is prepared, OVD or air h
• Procedure DMEK
  The main incision (2.8-3mm) is created superior or temporally at the corneal limbus and is accompanied by 2-3 smaller paracentesis incisions. An ophthalmic viscosurgical device (OVD) or a continuous infusion of water or air can be used to maintain the stability of the anterior chamber. The corneal endothelium is scored using a scoring instrument and the central diseased corneal endothelium is removed. The DMEK roll is poured into a basin and rinsed. The graft is then stained with 0.06% trypan b

Primary outcome measures

• BCVA 12m [Time frame: 12 months]

Secondary outcome measures (9)

• BCVA 3 and 6m [Time frame: 3 and 6 months]
• UCVA 3,6 and12m [Time frame: 3, 6 and 12 months]
• Change in refraction [Time frame: 3, 6 and 12 months]
• Proportion of high vision [Time frame: 12 months]
• EQ-5D-5L [Time frame: 3, 6 and 12 months]
• VFQ 25 [Time frame: 3, 6 and 12 months]
• ECC [Time frame: 3, 6 and 12 months]
• CCT [Time frame: 3, 6 and 12 months]
• Complications [Time frame: 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Belgium · 11 centers

• Antwerp University Hospital — Edegem
• AZ Maria Middelares — Ghent
• AZ Sint-Jan Brugge — Bruges
• AZ Imelda — Bonheiden
• Erasmus ziekenhuis Brussel — Brussels
• UZ Brussel — Brussels
• AZ Monica (campus Deurne) — Deurne
• Ziekenhuis Oost-Limburg (ZOL) — Genk
• … and 3 more centers

Publications

• de Bruyn B, Ni Dhubhghaill S, Claerhout I, Claes K, Deconinck A, Delbeke H, Huizing M, Krolo I, Muijzer M, Oellerich S, Roels D, Termote K, Van den Bogerd B, Van Gerwen V, Verhaegen I, Wisse R, Wouters K, Consortium TBC, Duchesne B, Koppen C. Belgian Endothelial Surgical Transplant of the Cornea (BEST cornea) protocol: clinical and patient-reported outcomes of Ultra-Thin Descemet Stripping Automat PMID 37714670

Identifiers

NCT: NCT05436665 · UZAntwerpen

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗