Cataract SurgeryETCFNCT06425666
Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy
A study testing Intervention group /arm 1 (Cataract surgery alone) in people with Cataract Surgery and Cataract and Fuchs Endothelial Corneal Dystrophy, run by University of Cologne at 4 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Surgery, Cataract and Fuchs Endothelial Corneal Dystrophy
- What is being tested?
- Intervention group /arm 1 (Cataract surgery alone)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 24 Jan 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
Denmark1 site, 1 recruiting
- Not yet recruiting
Department of Ophthalmology, Aarhus University Hospital
Aarhus N, Central Jutland, DK- 8200
Jesper Hjortdal, Prof., 78 45 46 44, 23346770 ext. 0045, jesper.hjortdal@clin.au.dk
Jesper Hjortdal, Prof.
Germany1 site, 1 recruiting
- Recruiting
Klinik für Ophthalmologie des Universitätsklinikums Köln
Cologne, North Rhine-Westphalia, 50937
Björn Bachmann, Prof., 0049-2214784308, bjoern.bachmann@uk-koeln.de
Björn Bachmann, Prof.
Netherlands1 site, 1 recruiting
- Not yet recruiting
Radboud-Universität Nijmegen
Nijmegen, Gelderland, GA 6525
Siamak Nobacht, Dr., 653613048 ext. 0031, Siamak.Nobacht@radboudumc.nl
Siamak Nobacht, Dr.
Spain1 site, 1 recruiting
- Not yet recruiting
Instituto de microcirugía ocular; Departamento de Cornea y Cirugia Refractiva
Barcelona, Barcelona, 08035
José Luis Güell, Dr., 934 000 700 ext. 0034, Jose.guell@imo.es
José Luis Güell, Dr.
About this study
Official title: 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.
Read the 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).
- Being tested
- Intervention group /arm 1 (Cataract surgery alone), Control group /arm 2: Corneal transplantation as Descemet Membrane Endothelial Keratoplasty (DMEK) in combination with cataract surgery (triple-DMEK)
- 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
- Medical subject headings
- Cataract, Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group /arm 1 (Cataract surgery alone)Procedure or surgery
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)Procedure or surgery
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%.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Control group /arm 2: Corneal transplantation as Descemet Membrane Endothelial Keratoplasty (DMEK) in combination with cataract surgery (triple-DMEK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA 22
Best corrected visual acuity (BCVA) is messured with EDTRS-charts (transformed to logMAR)
Measured: 22 weeks +/- 14 days after surgery
Secondary outcomes (21)
Change in visual acuity (BCVA)
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
Measured: Baseline (pre-op) and 22 weeks +/- 14 days after initial surgery
Contrast sensitivity
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
Measured: 22 weeks +/- 14 days after initial surgery
Change in contrast sensitivity
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
Measured: 22 weeks +/- 14 days after initial surgery
Optical quality measured by HD-analyzer
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
Measured: 22 weeks +/- 14 days after initial surgery
Change in optical quality measured by HD-analyzer
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
Measured: 22 weeks +/- 14 days after initial surgery
Optical quality measured by HD-analyzer
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
Measured: 22 weeks +/- 14 days after initial surgery
Change in optical quality measured by HD-analyzer
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
Measured: 22 weeks +/- 14 days after initial surgery
Optical quality measured by HD-analyzer
Specific measurement variable: Total score of Strehl ratio; Analysis metric (participant level): Value Method of aggregation (summary measure for each study group): Mean
Measured: 22 weeks +/- 14 days after initial surgery
Change in Optical quality measured by HD-analyzer
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
Measured: 22 weeks +/- 14 days after initial surgery
Refractive accuracy:spherical equivalent
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)
Measured: 22 weeks +/- 14 days after initial surgery
Corneal topography/ tomography parameters
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
Measured: 22 weeks +/- 14 days after initial surgery
Change in corneal topography/tomography parameters
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
Measured: At baseline and 22 weeks +/- 14 days after initial surgery
Central corneal thickness (CCT)
Specific measurement variable: CCT measured by Pentacam [μm]; Analysis metric (participant level): Value; Method of aggregation (summary measure for each study group): Mean
Measured: At baseline and 22 weeks +/- 14 days after initial surgery
Change in central corneal thickness (CCT)
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
Measured: At baseline and 22 weeks +/- 14 days after initial surgery
Quality of life
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
Measured: 22 weeks +/- 14 days after initial surgery
Change in quality of life
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
Measured: At baseline and at 22 weeks +/- 14 days after initial surgery
Change in central retinal thickness
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
Measured: At baseline and at 22 weeks +/- 14 days after initial surgery
Change in intraocular pressure (IOP)
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
Measured: At baseline and at 22 weeks +/- 14 days after initial surgery
Additional ocular surgeries
Specific measurement variable: Per patient anamnesis Analysis metric (participant level): Value (yes/no) Method of aggregation (summary measure for each study group): Proportion
Measured: At baseline and at 22 weeks +/- 14 days after initial surgery
Endothelial decompensation with indication for endothelial keratoplasty (either planned or already performed)
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
Measured: 22 weeks +/- 14 days after initial surgery
Cystoid macular edema
Specific measurement variable: CME visualized by OCT Analysis metric (participant level): Value [yes/no] Method of aggregation (summary measure for each study group): Proportion
Measured: 22 weeks +/- 14 days after initial surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start24 Jan 2025
- Primary completionMar 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- The Clinical Trials Centre Cologne, European Society of Cataract and Refractive Surgeons
- Responsible party
- Principal investigator, Björn Bachmann, University of Cologne
- Investigators
- Björn Bachmann, Prof., Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425666
- Sponsor's protocol ID
- Uni-Koeln-5135
- Other IDs
- ORG-100006227
- Acronym
- ETCF
- Status last verified
- Nov 2024
- First submitted
- 2 May 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Prospective Multicentre Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy (ETCF-trial)
- ClinicalTrials.gov ID
- NCT06425666
- Acronym / sponsor ID
- ETCF / Uni-Koeln-5135
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- The Clinical Trials Centre Cologne, European Society of Cataract and Refractive Surgeons
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Experimental intervention /arm 1 | Experimental | Procedure: Intervention group /arm 1 (Cataract surgery alone)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. |
| Control intervention /arm2 | Other | Procedure: Control group /arm 2: Corneal transplantation as Descemet Membrane Endothelial Keratoplasty (DMEK) in combination with cataract surgery (triple-DMEK)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Experimental intervention /arm 1 |
| 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%. | Procedure or surgery | Control intervention /arm2 |
Primary outcome
BCVA 22
Time frame: 22 weeks +/- 14 days after surgery
Best corrected visual acuity (BCVA) is messured with EDTRS-charts (transformed to logMAR)
21 secondary outcomes
Change in visual acuity (BCVA)
Time frame: Baseline (pre-op) and 22 weeks +/- 14 days after initial surgery
Contrast sensitivity
Time frame: 22 weeks +/- 14 days after initial surgery
Change in contrast sensitivity
Time frame: 22 weeks +/- 14 days after initial surgery
Optical quality measured by HD-analyzer
Time frame: 22 weeks +/- 14 days after initial surgery
Change in optical quality measured by HD-analyzer
Time frame: 22 weeks +/- 14 days after initial surgery
Optical quality measured by HD-analyzer
Time frame: 22 weeks +/- 14 days after initial surgery
Change in optical quality measured by HD-analyzer
Time frame: 22 weeks +/- 14 days after initial surgery
Optical quality measured by HD-analyzer
Time frame: 22 weeks +/- 14 days after initial surgery
Change in Optical quality measured by HD-analyzer
Time frame: 22 weeks +/- 14 days after initial surgery
Refractive accuracy:spherical equivalent
Time frame: 22 weeks +/- 14 days after initial surgery
Corneal topography/ tomography parameters
Time frame: 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
Central corneal thickness (CCT)
Time frame: 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
Quality of life
Time frame: 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
Change in central retinal thickness
Time frame: 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
Additional ocular surgeries
Time frame: 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
Cystoid macular edema
Time frame: 22 weeks +/- 14 days after initial surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Björn Bachmann, Prof. principal investigator
University Hospital of Cologne
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group /arm 1 (Cataract surgery alone) in people with Cataract Surgery and Cataract and Fuchs Endothelial Corneal Dystrophy, run by University of Cologne at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, Germany, Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Björn Bachmann, Prof. (0049-221 478-87476, bjoern.bachmann@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCVA 22 (time frame: 22 weeks +/- 14 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.