Clinical Trial

Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy

Study acronym: ETCF
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated February 21, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-05-17; most recent amendment 2025-02-19.
Status change: Not Yet Recruiting → Recruiting 2025-02-19
Trial Details
NCT Number NCT06425666
Lead Sponsor University of Cologne
Collaborators: The Clinical Trials Centre Cologne, European Society of Cataract and Refractive Surgeons
Conditions Cataract Surgery, Cataract and Fuchs Endothelial Corneal Dystrophy
Enrollment 120 participants
Start Date 2025-01-24
Primary Completion 2026-03 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2025-02-21