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)

What this Trial Is About

Researchers are comparing two types of corneal transplant surgeries, Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) and Descemet Membrane Endothelial Keratoplasty (DMEK), for patients with corneal endothelial failure. The study aims to evaluate both clinical outcomes and patient-reported quality of life across various conditions causing endothelial dysfunction. This trial involves multiple centers in Belgium and seeks to address variability in how these surgeries are currently offered to patients. Participants will be randomly assigned to receive either an ultra-thin DSAEK graft, which includes a thin layer of supporting tissue, or a DMEK graft that transplants only the endothelial layer with its membrane. Both grafts are prepared by specialized corneal banks. The surgeries involve precise techniques to remove diseased corneal tissue and insert the donor graft, with specific approaches for each type. Follow-up examinations occur at 3, 6, and 12 months after surgery. Throughout the study, participants will undergo assessments of vision clarity, refraction, and corneal thickness, along with quality of life questionnaires like EQ-5D-5L and VFQ 25. Researchers will monitor complications and measure endothelial cell counts at each follow-up. The main outcome focuses on best-corrected visual acuity at 12 months. This comprehensive evaluation helps understand how each surgery impacts both eye health and patient experience over time.

The Belgian Endothelial Surgical Transplant of the Cornea