Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06425666 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: ETCF
StatusRecruiting
PhaseNot applicable
Started
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 15, 2024 to Jan 24, 2025
    • Site details revised at 4 of 4 sites
    v3
  2. Start date: Jun 2024 to Dec 15, 2024v2 Show 5 more changesShow less
    • Primary endpoint revised
    • Eligibility criteria revised
    • Secondary endpoints: 16 to 21
    • Study description expanded, about 172 words
    • Site details revised at 4 of 4 sites
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06425666
Lead Sponsor University of Cologne
Collaborators: The Clinical Trials Centre Cologne, European Society of Cataract and Refractive Surgeons
Conditions
(from sponsor)		 Cataract Surgery, Cataract and Fuchs Endothelial Corneal Dystrophy
Related terms Cataract, Fuchs' Endothelial Dystrophy
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov