RecruitingNot ApplicableNCT06425666

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

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

Sponsor

University of Cologne

Enrollment

120 participants

Start Date

Jan 24, 2025

Study Type

INTERVENTIONAL

Conditions

Cataract Surgery Cataract and Fuchs Endothelial Corneal Dystrophy

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria11

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

Exclusion Criteria11

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

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Interventions

PROCEDUREIntervention 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.

PROCEDUREControl 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%.