Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Cologne
About this 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Patients with ocular and/or systemic comorbidity affecting vision or clinically proven anterior and/or posterior segment disease other than FECD and cataract (exclusion of macular disease or edema by OCT)
Iris synechiae, pupil diameter <6 mm after dilatation, pseudoexfoliation syndrome, subluxated lens, previous history of ocular trauma/surgery or inflammatory disease
Subjective diurnal changes in visual acuity with worse visual acuity in the morning
Corneal (epithelial) edema visible at slit lamp examination
Trial design
Treatments tested in this trial
- Intervention group /arm 1 (Cataract surgery alone)
- Control group /arm 2: Corneal transplantation as Descemet Membrane Endothelial Keratoplasty (DMEK) in combination with cataract surgery (triple-DMEK)
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Cologne
Lead sponsor
The Clinical Trials Centre Cologne
Collaborator
ESCRS (European Society of Cataract and Refractive Surgeons)
Collaborator
Source ClinicalTrials.gov