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

NCT06425666 | Recruiting

• 2 other identifiers: Uni-Koeln-5135ORG-100006227
• Study Type: interventional
• Target: 120
• Locations: 4 countries
• Sites: 4

Brief 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.

Conditions

Cataract Surgery; Cataract and Fuchs Endothelial Corneal Dystrophy

Keywords

Fuchs´ Endothelial Corneal Dystrophy Krachmer grade 3 and 4; nuclear cataract; Nuclear opalescence (NO) grades 2; Nuclear opalescence (NO) grades 3; Central corneal thickness

Outcome Measures

Primary Outcomes (1)

• BCVA 22

  Best corrected visual acuity (BCVA) is messured with EDTRS-charts (transformed to logMAR)

  22 weeks +/- 14 days after surgery

Secondary Outcomes (21)

• Change in visual acuity (BCVA)

  Baseline (pre-op) and 22 weeks +/- 14 days after initial surgery

• Contrast sensitivity

  22 weeks +/- 14 days after initial surgery

• Change in contrast sensitivity

  22 weeks +/- 14 days after initial surgery

• Optical quality measured by HD-analyzer

  22 weeks +/- 14 days after initial surgery

• Change in optical quality measured by HD-analyzer

  22 weeks +/- 14 days after initial surgery

Study Arms (2)

Experimental intervention /arm 1

EXPERIMENTAL

After randomisation the investigational therapy (arm 1), patients undergo a cataract surgery with preservation of the diseased endothelial cells. The cataract surgery will take approximately 10-20 minutes. The follow-up period after surgery will be 22 weeks ± 14 days.

Procedure: Intervention group /arm 1 (Cataract surgery alone)

Control intervention /arm2

OTHER

After randomisation, patients in the comparator therapy (arm 2) undergo triple-DMEK which is a cataract surgery combined with DMEK (removal of the diseased endothelial cells followed by transplantation of a healthy endothelial cell layer). Triple-DMEK takes approximately 5-10 minutes longer than cataract surgery. The follow-up period after surgery will be 22 weeks ± 14 days.

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

Interventions

Intervention group /arm 1 (Cataract surgery alone) PROCEDURE

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.

Experimental intervention /arm 1

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

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%.

Control intervention /arm2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead
• The Clinical Trials Centre Cologne: collaborator
• ESCRS (European Society of Cataract and Refractive Surgeons): collaborator

Study Sites (4)

Department of Ophthalmology, Aarhus University Hospital

Aarhus N, Central Jutland, DK- 8200, Denmark

NOT YET RECRUITING

Klinik für Ophthalmologie des Universitätsklinikums Köln

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Radboud-Universität Nijmegen

Nijmegen, Gelderland, GA 6525, Netherlands

NOT YET RECRUITING

Instituto de microcirugía ocular; Departamento de Cornea y Cirugia Refractiva

Barcelona, Barcelona, 08035, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Cataract; Fuchs' Endothelial Dystrophy

Interventions

Cataract Extraction; Control Groups

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Björn Bachmann, Prof.

  University Hospital Cologne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Björn Bachmann, Prof.

CONTACT

0049-221 478-87476; bjoern.bachmann@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: After screening and enrollement subjects will be randomly allocated to the trial groups (cataract surgery versus triple-DMEK, allocation rate 1:1)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: The trial will be a prospective, randomised, controlled, European, multicentre, open clinical trial in which patients with FECD and cataract will receive either cataract surgery without DMEK (intervention goup/arm 1) or triple-DMEK (DMEK in combination with cataract surgery; control group/arm 2). (Protocol V02\_0\_TC page 37)

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 22, 2024
• Study Start: January 24, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 21, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); DE (1); ES (1); DK (1)