An interventional study of Intervention group /arm 1 (Cataract surgery alone) and Control group /arm 2: Corneal transplantation as Descemet Membrane Endothelial Keratoplasty (DMEK) in combination with cataract surgery (triple-DMEK) in Cataract Surgery and Cataract and Fuchs Endothelial Corneal Dystrophy, sponsored by University of Cologne. Recruiting at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by University of Cologne · Not applicable, Interventional, and Treatment
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.
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).
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 120 is above the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →University of Cologne is the lead sponsor of 203 studies on the registry; 26 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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.
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%.
BCVA 22
Best corrected visual acuity (BCVA) is messured with EDTRS-charts (transformed to logMAR)
Time frame: 22 weeks +/- 14 days after surgery
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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)
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
Time frame: 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
Time frame: 22 weeks +/- 14 days after initial surgery
Plan to share: No
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