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RECRUITING
NCT06425666
NA

Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy

Sponsor: University of Cologne

View on ClinicalTrials.gov

Summary

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.

Official title: European Prospective Multicentre Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy (ETCF-trial)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-01-24

Completion Date

2026-06

Last Updated

2025-02-21

Healthy Volunteers

No

Interventions

PROCEDURE

Intervention group /arm 1 (Cataract surgery alone)

Cataract surgery (arm 1) is performed using a small incision technique. The tunnel is used both for cataract surgery and for implantation of the DMEK graft (arm 2). The centres confirmed that the main incision will be localized between 11 and 12 o'clock and will have a width of 2.4 to 2.8 mm. A tunnel suture will only be placed if there is leakage from the incisions. If cataract surgery alone (arm 1) is performed, a thin dispersive viscoelastic is applied to the endothelium for protection before phacoemulsification. A hydrophobic acrylic monofocal IOL will be implanted into the bag. The centers confirmed that Barret Universal II formula is the standard IOL calculation formula for both groups and for all axial lengths.

PROCEDURE

Control group /arm 2: Corneal transplantation as Descemet Membrane Endothelial Keratoplasty (DMEK) in combination with cataract surgery (triple-DMEK)

After cataract surgery DMEK is continued using the surgeon's standard technique for graft implantation and unfolding in triple-DMEK. In all cases the graft will be implanted using the same main incision as for IOL implantation. Once the DMEK graft is unrolled and attached to the posterior corneal stroma the complete anterior chamber will be filled with SF6 20%.

Locations (4)

Department of Ophthalmology, Aarhus University Hospital

Aarhus N, Central Jutland, Denmark

Klinik für Ophthalmologie des Universitätsklinikums Köln

Cologne, North Rhine-Westphalia, Germany

Radboud-Universität Nijmegen

Nijmegen, Gelderland, Netherlands

Instituto de microcirugía ocular; Departamento de Cornea y Cirugia Refractiva

Barcelona, Barcelona, Spain