Health Trials

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 groups

Locations

4
Denmark
Department of Ophthalmology, Aarhus University HospitalDK- 8200, Aarhus NCentral Jutland, Denmark
Germany
Klinik für Ophthalmologie des Universitätsklinikums Köln50937, CologneNorth Rhine-Westphalia, Germany
Netherlands
Radboud-Universität NijmegenGA 6525, NijmegenGelderland, Netherlands
Spain
Instituto de microcirugía ocular; Departamento de Cornea y Cirugia Refractiva08035, BarcelonaBarcelona, Spain

Sponsors 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