BEST CORNEA Study

A randomised multicentric parallel group pragmatic trial of Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) versus Descemet Membrane Endothelial Keratoplasty (DMEK) in corneal endothelial decompensation.

Principal Investigator: Prof. Dr. Sorcha Ni Dhubhghaill

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. Over the last two decades, surgical techniques have made major leaps forward by replacing the classic thick corneal graft with very thin grafts, so called lamellar grafts, in order to selectively replace the diseased tissue through minimally invasive microsurgery.

There are currently two types of lamellar grafts commonly used, the Descemet stripping automated endothelial keratoplasty (DSAEK) (the standard of care) and extremely thin Descemet membrane endothelial keratoplasty (DMEK) (the most recent development). Who performs which type of transplantation depends largely on the surgeons' discretion and both techniques have arguments in favour and against. No large study has been undertaken to date to clarify this issue. 

Aim of the study

The purpose of this trial is to use the scientific method of a randomized clinical trial (RCT) to determine which is the best corneal transplant technique for Belgium (and even beyond). Based on the results of this trials, we can then 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.

https://clinicaltrials.gov/study/NCT05436665