Belgian endothelial surgical transplant of the cornea (BEST cornea) protocol : clinical and patient-reported outcomes of ultra-thin descemet stripping automated endothelial keratoplasty (UT-DSAEK) versus descemet membrane endothelial keratoplasty (DMEK) - a multicentric, randomised, parallel group pragmatic trial in corneal endothelial decompensation

Barbara de Bruyn, Sorcha Ní Dhubhghaill, Ilse Claerhout, Kim Claes, Ann Deconinck, Heleen Delbeke, Manon Huizing, Iva Krolo, Marc Muijzer, Silke Oellerich, Dimitri Roels, Karolien Termote, Bert Van den Bogerd, Veerle Van Gerwen, Iris Verhaegen, Robert Wisse, Kristien Wouters, The Best Cornea Consortium, Bernard Duchesne, Carina Koppen

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Abstract

OBJECTIVES: Corneal blindness is the third most frequent cause of blindness globally. Damage to the corneal endothelium is a leading indication for corneal transplantation, which is typically performed by lamellar endothelial keratoplasty. There are two conventional surgical techniques: Ultra-Thin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK) and Descemet Membrane Endothelial Keratoplasty (DMEK). The purpose of this study is to compare both techniques.

METHODS AND ANALYSIS: The trial compares UT-DSAEK and DMEK in terms of clinical and patient reported outcomes using a pragmatic, parallel, multicentric, randomised controlled trial with 1:1 allocation with a sample size of 220 participants across 11 surgical centres. The primary outcome is the change in best-corrected visual acuity at 12 months. Secondary outcomes include corrected and uncorrected vision, refraction, proportion of high vision, quality of life (EQ-5D-5L and VFQ25), endothelial cell counts and corneal thickness at 3, 6 and 12 months follow-up appointments. Adverse events will also be compared 12 months postoperatively.

ETHICS AND DISSEMINATION: The protocol was reviewed by ethical committees of 11 participating centres with the sponsor centre issuing the final definitive approval. The results will be disseminated at clinical conferences, by patient partner groups and open access in peer-reviewed journals.

GOVERNANCE OF THE TRIAL: Both, trial management group and trial steering committee, are installed with representatives of all stakeholders involved including surgeons, corneal bankers, patients and external experts.

TRIAL REGISTRATION NUMBER: NCT05436665.

Original languageEnglish
Article numbere072333
JournalBMJ Open
Volume13
Issue number9
Number of pages10
ISSN2044-6055
DOIs
Publication statusPublished - 2023

Keywords

  • Humans
  • Endothelium, Corneal/surgery
  • Belgium
  • Descemet Membrane
  • Quality of Life
  • Corneal Diseases/surgery
  • Corneal Transplantation
  • Cornea
  • Patient Reported Outcome Measures
  • Blindness
  • Randomized Controlled Trials as Topic

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