Trial Comparing Cataract Surgery with Triple-DMEK in Patients with Cataract and Fuchs Endothelial Corneal Dystrophy (ETCF)

February 19, 2025 updated by: Björn Bachmann, University of Cologne

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

After signing the informed consent, patients are screened for eligibility for the trial regarding in- and exclusion criteria.

Different tests will be performed like ocular examination including slit lamp examination, fundus examination, IOP measurement, BCVA, Pentacam imaging, and Macular-OCT, vital signs. In addition, women below age of 60 have to perform a urine pregnancy test. Once all inclusion criteria and none of the exclusion criteria are met, the patient will be enrolled into the trial and will receive a subject-ID.

The Baseline Visit can take place up to 7 days after enrolment of the subject into the clinical trial. At the Baseline Visit a photograph of the cornea in retroillumination will be taken (can be taken either at Screening & Enrolment Visit or at Baseline Visit) and uploaded into the eCRF for central grading by CORIC.

In addition, subjects have to complete vision related quality of life questionnaires and changes in relevant medical history/concomitant diseases as well as concomitant medications have to be documented.

Furthermore, a contrast sensitivity test and an optical quality test (if device available) will be peformed.

After all investigations are completed, the subject will be randomised via the central 24-7 Internetrandomisation service ALEA and distributed to the respective treatment groups.

Intervention (surgery):

On that day and before starting intervention all women below 60 years undergo a pregnancy test and changes in relevant medical history/concomitant diseases have to be documented. In arm 1 (intervention group) patients undergo exclusively cataract surgery, in arm 2 (control group) patients undergo triple-DMEK, i.e. cataract surgery and DMEK.

The immediate follow-up appointments for clinical examinations are, as per standard of care, at the discretion of the respective trial centres treating physician.

The Post-operative Visit will take place 22 weeks ± 14 days after the surgical intervention. During the Post-operative Visit an ocular examination including slit lamp examination, fundus examination, IOP measurement, BCVA, Pentacam imaging, contrast sensivity test, an optical quality test (if device available), and Macular-OCT will be performed. In addition, vital signs will be taken and subjects have to complete the vision related quality-of-life questionnaires again. Concomitant medications and AEs/SAEs have to be documented.

The duration of the clinical trial for every individual subject will be up to 29 weeks (time from Screening & Enrolment Visit to Post-operative Visit).

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
    • Midtjylland
      • Aarhus N, Midtjylland, Denmark, DK- 8200
        • Not yet recruiting
        • Department of Ophthalmology, Aarhus University Hospital
        • Contact:
        • Contact:
          • Jesper Hjortdal, Prof.
  • Germany
    • NRW
      • Köln, NRW, Germany, 50937
        • Recruiting
        • Klinik für Ophthalmologie des Universitätsklinikums Köln
        • Contact:
        • Contact:
          • Björn Bachmann, Prof.
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, GA 6525
        • Not yet recruiting
        • Radboud-Universität Nijmegen
        • Contact:
        • Contact:
          • Siamak Nobacht, Dr.
  • Spain
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Instituto de microcirugía ocular; Departamento de Cornea y Cirugia Refractiva
        • Contact:
        • Contact:
          • José Luis Güell, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with FECD and nuclear cataract in study eye
  2. Male and female patients ≥18 years of age
  3. Subject must be able to understand and read the national language.
  4. Written informed consent prior to any study-related procedures
  5. Nuclear opalescence (NO) grades 2 and 3 according to the lens opacities classification system III (LOCS III)
  6. 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)
  7. Central corneal thickness (CCT) measured with Pentacam below 620 µm between 8:00 am and 01:00 pm
  8. BCVA logMAR < 0,7 and > 0,1
  9. No previous cataract surgery or triple-DMEK on the opposite side
  10. Pentacam quality specification: "OK"
  11. For women below age of 60 negative urine pregnancy test

Exclusion Criteria:

  1. 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)
  2. Iris synechiae, pupil diameter <6 mm after dilatation, pseudoexfoliation syndrome, subluxated lens, previous history of ocular trauma/surgery or inflammatory disease
  3. Subjective diurnal changes in visual acuity with worse visual acuity in the morning
  4. Corneal (epithelial) edema visible at slit lamp examination
  5. Preoperative anterior chamber depth below 2 mm
  6. Participation in other interventional trials parallel or within the last 4 weeks
  7. Systemic use of Alpha-1-Adrenozeptor-Antagonists, immunosuppressive therapy or chemotherapy
  8. Pregnant women and nursing mothers
  9. Persons with any kind of dependency on the principal investigator or employed by the sponsor or principal investigator
  10. Legally incapacitated persons
  11. Persons held in an institution by legal or official order

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control intervention /arm2

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)
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%.
Experimental: Experimental intervention /arm 1

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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BCVA 22
Time Frame: 22 weeks +/- 14 days after surgery
Best corrected visual acuity (BCVA) is messured with EDTRS-charts (transformed to logMAR)
22 weeks +/- 14 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in visual acuity (BCVA)
Time Frame: Baseline (pre-op) and 22 weeks +/- 14 days after initial surgery
Specific measurement variable: ETDRS-charts (transformed to logMAR); Analysis metric (participant level): Difference value at follow-up- baseline value Method of aggregation (summary measure for each study group): Mean difference
Baseline (pre-op) and 22 weeks +/- 14 days after initial surgery
Contrast sensitivity
Time Frame: 22 weeks +/- 14 days after initial surgery
Specific measurement variable: Total score of Freiburg Vision Test "FrACT"; Analysis metric (participant level): Value Method of aggregation (summary measure for each study group): Mean
22 weeks +/- 14 days after initial surgery
Change in contrast sensitivity
Time Frame: 22 weeks +/- 14 days after initial surgery
Specific measurement variable: Total score of Freiburg Vision Test "FrACT"; Analysis metric (participant level): Difference Value at follow-up-baseline value; Method of aggregation (summary measure for each study group): Mean difference
22 weeks +/- 14 days after initial surgery
Optical quality measured by HD-analyzer
Time Frame: 22 weeks +/- 14 days after initial surgery
Specific measurement variable: Total score of objective scattering index (OSI); Analysis metric (participant level): Value Method of aggregation (summary measure for each study group): Mean
22 weeks +/- 14 days after initial surgery
Change in optical quality measured by HD-analyzer
Time Frame: 22 weeks +/- 14 days after initial surgery
Specific measurement variable: Total score of objective scattering index (OSI); Analysis metric (participant level): Difference value at follow-up- baseline value Method of aggregation (summary measure for each study group): Mean difference
22 weeks +/- 14 days after initial surgery
Optical quality measured by HD-analyzer
Time Frame: 22 weeks +/- 14 days after initial surgery
Specific measurement variable: Total score of Modulation transfer function (MTF) cut-off; Analysis metric (participant level): value Method of aggregation (summary measure for each study group): Mean
22 weeks +/- 14 days after initial surgery
Change in optical quality measured by HD-analyzer
Time Frame: 22 weeks +/- 14 days after initial surgery
Specific measurement variable: Total score of Modulation transfer function (MTF) cut-off; Analysis metric (participant level): Difference value at follow-up - baseline value Method of aggregation (summary measure for each study group): Mean difference
22 weeks +/- 14 days after initial surgery
Optical quality measured by HD-analyzer
Time Frame: 22 weeks +/- 14 days after initial surgery
Specific measurement variable: Total score of Strehl ratio; Analysis metric (participant level): Value Method of aggregation (summary measure for each study group): Mean
22 weeks +/- 14 days after initial surgery
Change in Optical quality measured by HD-analyzer
Time Frame: 22 weeks +/- 14 days after initial surgery
Specific measurement variable: Total score of Strehl ratio; Analysis metric (participant level): Difference value at follow-up- baseline value Method of aggregation (summary measure for each study group): Mean difference
22 weeks +/- 14 days after initial surgery
Refractive accuracy:spherical equivalent
Time Frame: 22 weeks +/- 14 days after initial surgery
Specific measurement variable: Deviation from target refraction from IOL calculation [D], Analysis metric (participant level): Value Method of aggregation (summary measure for each study group): Mean numerical prediction error (ME) and Mean absolute prediction error (MAE)
22 weeks +/- 14 days after initial surgery
Corneal topography/ tomography parameters
Time Frame: 22 weeks +/- 14 days after initial surgery
Specific measurement variable: Corneal densitometry (grayscale unit GSU) (anterior, central, posterior and total layer) Analysis metric (participant level): Value; Method of aggregation (summary measure for each study group): Mean
22 weeks +/- 14 days after initial surgery
Change in corneal topography/tomography parameters
Time Frame: At baseline and 22 weeks +/- 14 days after initial surgery
Specific measurement variable: Corneal densitometry (grayscale unit GSU) (anterior, central, posterior and total layer); Analysis metric (participant level): Difference value at follow-up - baseline value; Method of aggregation (summary measure for each study group): Mean difference
At baseline and 22 weeks +/- 14 days after initial surgery
Central corneal thickness (CCT)
Time Frame: At baseline and 22 weeks +/- 14 days after initial surgery
Specific measurement variable: CCT measured by Pentacam [μm]; Analysis metric (participant level): Value; Method of aggregation (summary measure for each study group): Mean
At baseline and 22 weeks +/- 14 days after initial surgery
Change in central corneal thickness (CCT)
Time Frame: At baseline and 22 weeks +/- 14 days after initial surgery
Specific measurement variable: CCT measured by Pentacam [μm]; Analysis metric (participant level): Difference value at follow-up - baseline value Method of aggregation (summary measure for each study group): Mean difference
At baseline and 22 weeks +/- 14 days after initial surgery
Quality of life
Time Frame: 22 weeks +/- 14 days after initial surgery
Specific measurement variable: Catquest-9SF (all centers) and V-Fuchs (Germany only); Analysis metric (participant level): Total score [no dimension]; Method of aggregation (summary measure for each study group): Mean
22 weeks +/- 14 days after initial surgery
Change in quality of life
Time Frame: At baseline and at 22 weeks +/- 14 days after initial surgery
Specific measurement variable: Catquest-9SF (all centers) and V-Fuchs (Germany only); Analysis metric (participant level): Difference total score at follow-up- baseline total score; Method of aggregation (summary measure for each study group): Mean difference
At baseline and at 22 weeks +/- 14 days after initial surgery
Change in central retinal thickness
Time Frame: At baseline and at 22 weeks +/- 14 days after initial surgery
Specific measurement variable: Measured by OCT Analysis metric (participant level): Difference value at follow-up- baseline value; Method of aggregation (summary measure for each study group): Mean difference
At baseline and at 22 weeks +/- 14 days after initial surgery
Change in intraocular pressure (IOP)
Time Frame: At baseline and at 22 weeks +/- 14 days after initial surgery
Specific measurement variable: IOP [mmHg] Analysis metric (participant level): Difference value at follow-up - baseline value Method of aggregation (summary measure for each study group): Mean difference
At baseline and at 22 weeks +/- 14 days after initial surgery
Additional ocular surgeries
Time Frame: At baseline and at 22 weeks +/- 14 days after initial surgery
Specific measurement variable: Per patient anamnesis Analysis metric (participant level): Value (yes/no) Method of aggregation (summary measure for each study group): Proportion
At baseline and at 22 weeks +/- 14 days after initial surgery
Endothelial decompensation with indication for endothelial keratoplasty (either planned or already performed)
Time Frame: 22 weeks +/- 14 days after initial surgery
Specific measurement variable: Per patient anamnesis (decision made by treating ophthalmologist; incl. ophthalmologist outside the study team) Analysis metric (participant level): Value [yes/no] Method of aggregation (summary measure for each study group): Proportion
22 weeks +/- 14 days after initial surgery
Cystoid macular edema
Time Frame: 22 weeks +/- 14 days after initial surgery
Specific measurement variable: CME visualized by OCT Analysis metric (participant level): Value [yes/no] Method of aggregation (summary measure for each study group): Proportion
22 weeks +/- 14 days after initial surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Collaborators

The Clinical Trials Centre Cologne
ESCRS (European Society of Cataract and Refractive Surgeons)

Investigators

  • Principal Investigator: Björn Bachmann, Prof., University Hospital Cologne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

May 2, 2024

First Submitted That Met QC Criteria

May 17, 2024

First Posted (Actual)

May 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uni-Koeln-5135
  • ORG-100006227 (Other Identifier: ESCRS (European society of Cataract and Refractive Surgeons))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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