BEST CORNEA: A randomised multicentric parallel group pragmatic trial of Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) versus Descemet Membrane Endothelial Keratoplasty (DMEK) in corneal endothelial decompensation (KCE-201254)

Summary (French or Dutch)

Losing vision at an older age can have a major impact on our ability to look after ourselves, to manage our medical needs, and to preserve our independence and dignity. One of the eye's structures that can become affected is the inner layer of the cornea known as the endothelium. Corneal endothelial dysfunction is a disease that usually affects the elderly. It gradually blurs vision and, if left untreated, can result in a painful and blind eye. Corneal transplantation is the only way to treat this disease. Thankfully, surgical techniques have made major leaps forward in the past decade by replacing the classic thick corneal graft with very thin layers in order to selectively replace the diseased tissue through minimally invasive microsurgery.
Some surgeons believe that the thinner the graft, the better the result. However, this belief has not yet been proven conclusively. It has also been proposed that thinner DMEK grafts might result in better vision retention, faster recovery, and are more resistant to 'transplant rejection'. On the other hand, these thinner grafts could lead to more complications or might require re-operations, so they may not be worth it in the long run. There are currently two type of grafts commonly used, the DSAEK (the standard of care) and extremely thin DMEK (the most recent development).
Who performs which graft depends largely on the surgeons' discretion and both techniques have arguments in favour and against. No study has been undertaken to date to clarify this issue and to put it to bed as the go-to, preferred scientific technique. The purpose of this trial is to use the scientific method of RCT to determine which is the best corneal transplant technique for Belgium (and even beyond). If we can determine a clear winner, then we can help encourage both surgeons and corneal bankers to invest their time, energy, and donor tissue into ensuring that the best corneal graft is available to patients that needs them.