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).
