Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy
Recruiting now · Not applicable
Conditions studied: Cataract Surgery, Cataract and Fuchs Endothelial Corneal Dystrophy
In brief
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.
Key facts
- Study ID
- NCT06425666
- Run by
- University of Cologne
- People needed
- 120
- Starts
- 2025-01-24
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2025-02-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Nuclear opalescence (NO) grades 2 and 3 according to the lens opacities classification system III (LOCS III)
- Krachmer grade (3 [2-5 mm diameter area with confluent guttae]; 4 [ > 5 mm diameter area with confluent guttae] without edema identified by slit lamp examination)
- Central corneal thickness (CCT) measured with Pentacam below 620 µm between 8:00 am and 01:00 pm
- BCVA logMAR < 0,7 and > 0,1
- No previous cataract surgery or triple-DMEK on the opposite side
- Pentacam quality specification: "OK"
- For women below age of 60 negative urine pregnancy test
You may not qualify if…
- 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
- Preoperative anterior chamber depth below 2 mm
- Participation in other interventional trials parallel or within the last 4 weeks
- Systemic use of Alpha-1-Adrenozeptor-Antagonists, immunosuppressive therapy or chemotherapy
- Pregnant women and nursing mothers
- Persons with any kind of dependency on the principal investigator or employed by the sponsor or principal investigator
- Legally incapacitated persons
- Persons held in an institution by legal or official order
Where it is running
- Klinik für Ophthalmologie des Universitätsklinikums Köln — Cologne, North Rhine-Westphalia, Germany (enrolling)
- Department of Ophthalmology, Aarhus University Hospital — Aarhus N, Central Jutland, Denmark
- Radboud-Universität Nijmegen — Nijmegen, Gelderland, Netherlands
- Instituto de microcirugía ocular; Departamento de Cornea y Cirugia Refractiva — Barcelona, Barcelona, Spain
Full record on ClinicalTrials.gov
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