Actively Recruiting
European Prospective Multicentre Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy (ETCF-trial)
Led by University of Cologne · Updated on 2025-02-21
120
Participants Needed
4
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University of Cologne
Lead Sponsor
T
The Clinical Trials Centre Cologne
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two surgical methods in patients with cataract and Fuchs Endothelial Corneal Dystrophy (FECD) to see if there is a difference in best corrected visual acuity (BCVA). The study evaluates cataract surgery alone versus cataract surgery combined with removal of diseased endothelial cells and Descemet's membrane followed by transplantation of a healthy endothelial cell layer (triple-DMEK). Secondary goals include comparing other visual functions, eye structure changes, safety, and quality of life between the two methods. After enrolling and confirming eligibility, patients are randomly assigned to one of two groups. In the intervention group, patients receive cataract surgery alone, which takes about 10-20 minutes. In the control group, patients undergo the triple-DMEK procedure, which includes cataract surgery plus corneal transplantation and takes about 5-10 minutes longer. Women under 60 have a pregnancy test before surgery. Follow-up care continues for about 22 weeks after surgery. Participants undergo multiple eye exams and tests before and after surgery, including slit lamp and fundus exams, intraocular pressure measurement, Pentacam imaging, macular OCT, contrast sensitivity, and optical quality tests. They also complete vision-related quality of life questionnaires. Researchers monitor changes in vision, eye structure, and complications up to 29 weeks from enrollment through the post-operative visit. Safety and medication use are tracked throughout the study.
CONDITIONS
Brief Title
Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with Fuchs Endothelial Corneal Dystrophy and nuclear cataract in the study eye
- Male and female patients 18 years of age or older
- Able to understand and read the national language
- Written informed consent before any study procedures
- Nuclear opalescence grades 2 and 3 according to lens opacities classification system III
- Krachmer grade 3 or 4 without edema as identified by slit lamp examination
- Central corneal thickness below 620 micrometers measured between 8:00 am and 1:00 pm
- Best corrected visual acuity logMAR less than 0.7 and greater than 0.1
- No previous cataract surgery or triple-DMEK on the opposite eye
- Pentacam quality specification must be "OK"
- Women under 60 years must have a negative urine pregnancy test
You will not qualify if you...
- Ocular or systemic diseases affecting vision other than Fuchs Endothelial Corneal Dystrophy and cataract
- Iris synechiae, pupil diameter less than 6 mm after dilation, pseudoexfoliation syndrome, subluxated lens, previous ocular trauma, surgery, or inflammatory disease
- Subjective diurnal changes with worse vision in the morning
- Corneal epithelial edema visible on slit lamp examination
- Anterior chamber depth below 2 mm before surgery
- Participation in other interventional trials currently or within last 4 weeks
- Use of alpha-1-adrenoceptor antagonists, immunosuppressive therapy, or chemotherapy
- Pregnant or nursing women
- Persons dependent on or employed by the principal investigator or sponsor
- Legally incapacitated persons
- Persons held in institutions by legal or official order
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 7 days after enrollment
Participants complete vision-related quality of life questionnaires, undergo ocular imaging and tests including contrast sensitivity and optical quality tests, and have relevant medical history documented. A cornea photograph for central grading is taken either at screening or baseline.
1 visit (in-person)
Duration - Single day (surgery day)
Participants undergo assigned surgery: cataract surgery alone or triple-DMEK (cataract surgery combined with corneal transplantation). Women under 60 years have a pregnancy test before surgery and medical history is updated.
1 visit (in-person)
Duration - 22 weeks ± 14 days after surgery
Participants have a post-operative visit approximately 22 weeks after surgery including ocular examinations, imaging, contrast sensitivity and optical quality tests, vital signs, vision-related quality of life questionnaires, and documentation of medications and adverse events.
1 visit (in-person)
Trial Site Locations
Total: 4 locations
1
Department of Ophthalmology, Aarhus University Hospital
Aarhus N, Central Jutland, Denmark, DK- 8200
Not Yet Recruiting
2
Klinik für Ophthalmologie des Universitätsklinikums Köln
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
3
Radboud-Universität Nijmegen
Nijmegen, Gelderland, Netherlands, GA 6525
Not Yet Recruiting
4
Instituto de microcirugía ocular; Departamento de Cornea y Cirugia Refractiva
Barcelona, Barcelona, Spain, 08035
Not Yet Recruiting
Research Team
B
Björn Bachmann, Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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