Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy
NCT ID: NCT06425666
Last Updated: 2025-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-01-24
2026-06-30
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
(Protocol V02\_0\_TC page 37)
TREATMENT
NONE
Study Groups
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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.
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.
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.
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%.
Interventions
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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.
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%.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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The Clinical Trials Centre Cologne
OTHER
ESCRS (European Society of Cataract and Refractive Surgeons)
UNKNOWN
University of Cologne
OTHER
Responsible Party
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Björn Bachmann
Clinical Professor
Principal Investigators
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Björn Bachmann, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Cologne
Locations
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Department of Ophthalmology, Aarhus University Hospital
Aarhus N, Central Jutland, Denmark
Klinik für Ophthalmologie des Universitätsklinikums Köln
Cologne, North Rhine-Westphalia, Germany
Radboud-Universität Nijmegen
Nijmegen, Gelderland, Netherlands
Instituto de microcirugía ocular; Departamento de Cornea y Cirugia Refractiva
Barcelona, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ORG-100006227
Identifier Type: OTHER
Identifier Source: secondary_id
Uni-Koeln-5135
Identifier Type: -
Identifier Source: org_study_id
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