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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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%.
Department of Ophthalmology, Aarhus University Hospital
Aarhus N, Central Jutland, Denmark
NOT_YET_RECRUITINGKlinik für Ophthalmologie des Universitätsklinikums Köln
Cologne, North Rhine-Westphalia, Germany
RECRUITINGRadboud-Universität Nijmegen
Nijmegen, Gelderland, Netherlands
NOT_YET_RECRUITINGInstituto de microcirugía ocular; Departamento de Cornea y Cirugia Refractiva
Barcelona, Barcelona, Spain
NOT_YET_RECRUITINGBCVA 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
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