120
Participants
Start Date
January 24, 2025
Primary Completion Date
March 31, 2026
Study Completion Date
June 30, 2026
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.
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%.
RECRUITING
Klinik für Ophthalmologie des Universitätsklinikums Köln, Cologne
NOT_YET_RECRUITING
Department of Ophthalmology, Aarhus University Hospital, Aarhus N
NOT_YET_RECRUITING
Radboud-Universität Nijmegen, Nijmegen
NOT_YET_RECRUITING
Instituto de microcirugía ocular; Departamento de Cornea y Cirugia Refractiva, Barcelona
The Clinical Trials Centre Cologne
OTHER
ESCRS (European Society of Cataract and Refractive Surgeons)
UNKNOWN
University of Cologne
OTHER