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

NARecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

January 24, 2025

Primary Completion Date

March 31, 2026

Study Completion Date

June 30, 2026

Conditions
Cataract SurgeryCataract and Fuchs Endothelial Corneal Dystrophy
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%.

Trial Locations (4)

50937

RECRUITING

Klinik für Ophthalmologie des Universitätsklinikums Köln, Cologne

DK- 8200

NOT_YET_RECRUITING

Department of Ophthalmology, Aarhus University Hospital, Aarhus N

GA 6525

NOT_YET_RECRUITING

Radboud-Universität Nijmegen, Nijmegen

08035

NOT_YET_RECRUITING

Instituto de microcirugía ocular; Departamento de Cornea y Cirugia Refractiva, Barcelona

All Listed Sponsors
collaborator

The Clinical Trials Centre Cologne

OTHER

collaborator

ESCRS (European Society of Cataract and Refractive Surgeons)

UNKNOWN

lead

University of Cologne

OTHER