European Prospective Multicentre Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy (ETCF-trial)
The purpose of the study is to investigate whether there is a difference in BCVA in patients who receive one of the following two surgeries: intervention group (arm 1) cataract surgery alone and control group (arm 2) cataract surgery combined with removal of the diseased endothelial cells and the attached Descemet's membrane followed by transplantation of a healthy endothelial cell layer with attached Descemet's membrane (triple-DMEK group; comparator therapy). The secondary objectives are to compare the two surgical methods with regard to other visual functions and optical as well as morphological differences, to safety, to quality of life, and to safety.
• Patients with FECD and nuclear cataract in study eye
• Male and female patients ≥18 years of age
• Subject must be able to understand and read the national language.
• Written informed consent prior to any study-related procedures
• Nuclear opalescence (NO) grades 2 and 3 according to the lens opacities classification system III (LOCS III)
• Krachmer grade (3 \[2-5 mm diameter area with confluent guttae\]; 4 \[ \> 5 mm diameter area with confluent guttae\] without edema identified by slit lamp examination)
• Central corneal thickness (CCT) measured with Pentacam below 620 µm between 8:00 am and 01:00 pm
• BCVA logMAR \< 0,7 and \> 0,1
• No previous cataract surgery or triple-DMEK on the opposite side
⁃ Pentacam quality specification: OK
⁃ For women below age of 60 negative urine pregnancy test