Cataract Fuchs Endothelial Corneal Dystrophy (FECD) cataract
Conditions
Interventions
- 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)
Sponsors
Universiteit Keulen
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Patients with FECD and nuclear cataract in study eye. 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. logMAR BCVA 0,1 9. No previous cataract surgery or triple-DMEK on the opposite side 10. Pentacam quality specification: *OK* 11. For women below age 60 negative urine pregnancy test
Exclusion criteria
Exclusion criteria: 1. 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) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate whether there is a difference in best corrected visual acuity (BCVA) in patients treated with one of the following two surgeries: (1) cataract surgery with preservation of the diseased endothelial cells (*cataract surgery alone*, intervention group/arm 1); (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*, control group/arm 2). Primary Endpoint: Best corrected visual acuity (BCVA) 22 weeks +/- 14 days after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| - To compare the two surgical arms with regard to further visual function. - To compare the two surgical arms with regard to optical quality of the cornea. - To compare the two surgical arms with regard to refraction. - To compare the two surgical arms with regard to morphology of the cornea. - To compare the two surgical arms with regard to quality of life. - To compare the two surgical arms with regard to safety. Secondary Endpoints: -Change in BCVA from baseline - Contrast sensitivity and change from baseline - Objective scattering index [OSI], Modulation transfer function (MTF) cut-off and Strehl ratio and change from baseline - Deviation in spherical equivalent from target refraction from IOL-calculation - Corneal topography and tomography parameters and change from baseline - Central corneal thickness (CCT) and change from baseline - Patient reported outcome measures and change from baseline - Change in central retinal thickness from baseline - Change in intraocular pressure (IOP) from baseline - Additional ocular surgeries - Postoperative endothelial decompensation - Presence of cystoid macular edema | — |
Countries
Denmark, Germany, Netherlands, Spain
Contacts
Public ContactMJJR Crombag
Clinical Trial Center Maastricht
Outcome results
None listed