Abstract
Purpose The objective of this study is to compare two surgical techniques for lamellar endothelial keratoplasty, UT-DSAEK and DMEK, for the treatment of corneal endothelium disease, mainly Fuchs endothelial corneal dystrophy and bullous keratopathy. This study will use wide inclusion criteria, over a large surgical consortium. The goal is to determine which is the most appropriate surgical approach for corneal disease, which is the third leading cause of blindness globally.
Methods This study is conducted as a pragmatic, parallel, multicentric, randomized controlled trial involving 220 participants from 11 surgical centers. The protocol was prepared by a collaborative consortium that included surgeons, corneal bank personnel, patients, patient advocacy groups, the funder and international experts. The participants will be allocated in a 1:1 ratio to undergo either UT-DSAEK or DMEK. The two types of cornea grafts are prepared using standardised techniques, respectively in two subspecialized corneal banks. Clinical and patient-reported outcomes will be assessed. Coded data will be recorded in the study software databank (REDCap).
Results The primary outcome is the change in BCVA at 12 months. The secondary outcomes include the corrected and uncorrected vision, refraction, proportion of high vision, quality of life, endothelial cell counts and corneal thickness at 3, 6, and 12-month follow-up appointments. Complications will also be compared 12-months postoperatively. Today advocates of DMEK assert that it yields superior results and faster recovery, with lower rates of rejection. On the other hand, proponents of UT-DSAEK argue that it achieves comparable outcomes while requiring fewer re-interventions, such as re-bubbling.
Conclusion Study with broad inclusion criteria across multiple surgical centers in order to determine the optimal surgical approach. Additional benefits are centralizing graft preparation, enhancing operating room efficiency, potentially lowering graft rejection rates, contribution to the training of the appropriate technique and enhancing quality and safety of corneal surgery.
