Fuchs' Endothelial Corneal Dystrophy, Bullous Keratopathy, Iridocorneal Endothelial Syndrome, Posterior Polymorphous Dystrophy, Endothelial Dysfunction
Conditions
Brief summary
The purpose of this study is evaluate the outcome after posterior lamellar keratoplasty (DMEK and Ultra-thin DSAEK) for corneal transplantation.
Interventions
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18 or older * Scheduled to undergo endothelial keratoplasty * Able to provide written informed consent.
Exclusion criteria
* Age less than 18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual acuity (change from baseline) | 1, 3, 6, and 12 months and annually |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure (change from baseline) | 1, 3, 6, and 12 months and annually | — |
| Manifest refraction (change from baseline) | 1, 3, 6, 12 months and annually | — |
| corneal pachymetry (change from baseline) | 1, 3, 6, 12 months and annually | — |
| Quality of Life, NEI-VFQ 25 (change from baseline) | 3, 12 months, annualy | Questionnaire |
| Endothelial cell density (change from baseline) | 1, 3, 6, and 12 months and annually | — |
| Anterior Segment OCT of cornea and anterior chamber angle (change from baseline) | 1, 3, 6, and 12 months and annually | — |
| postoperative Medication (change from baseline) | 1,3,6 and 12 months and annually | — |
| Histological Sample of Recipient's Descemet Membrane | intraoperative | Recipient's Descemet Membrane |
| corneal topography (change from baseline) | 1, 3, 6, and 12 months and annually | — |
Countries
Germany
Contacts
Primary ContactAnna-Karina Maier, MD
Outcome results
None listed