Actively Recruiting
Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy
Led by University of Cologne · Updated on 2025-02-21
120
Participants Needed
4
Research Sites
70 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
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.
CONDITIONS
Official 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
- Provided written informed consent before any study procedures
- Nuclear opalescence grades 2 and 3 based on lens opacities classification system III
- Krachmer grade 3 (2-5 mm area with confluent guttae) or grade 4 (>5 mm area with confluent guttae) without edema, confirmed by slit lamp exam
- Central corneal thickness under 620 micrometers measured with Pentacam 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"
- For women under 60 years, a negative urine pregnancy test is required
You will not qualify if you...
- Presence of eye or systemic diseases affecting vision other than Fuchs Endothelial Corneal Dystrophy and cataract (e.g., macular disease or edema)
- Iris synechiae, pupil diameter less than 6 mm after dilation, pseudoexfoliation syndrome, subluxated lens, history of eye trauma, surgery, or inflammation
- Subjective daily changes in vision with worse acuity in the morning
- Corneal epithelial edema visible on slit lamp exam
- Anterior chamber depth less than 2 mm before surgery
- Participation in other interventional trials currently or within the past 4 weeks
- Use of systemic Alpha-1-Adrenoceptor antagonists, immunosuppressive therapy, or chemotherapy
- Pregnant women or nursing mothers
- Being dependent on or employed by the principal investigator or sponsor
- Legal incapacity
- Being held in an institution by legal or official order
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here