Fuchs endothelial dystrophy and bullous keratopathy / corneal disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Patients with Fuchs endothelial dystrophy, bullous keratopathy or failed previous corneal transplant - Patient scheduled for DMEK surgery - 18 years and older
Exclusion criteria
Exclusion criteria: - Patients with ocular surface disease and delayed epithelial healing. - Patients with an additional corneal inflammation or other inflammatory disease. - Patient with concomitant ocular disease not related to the corneal disorder, or any type of circumstances that may be expected to adversely affect the efficacy of the surgery. - Severe diabetes. - Patients that may not be able to keep the position for 15 min. - Not able to understand the language used in the clinic (Dutch). - Inability to give informed consent for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in corneal layers as observed by confocal microscopy (e.g. increase in the number of activated keratocytes) that are typical before and/or during allograft rejection, significant changes in endothelial cell morphology and density, changes in intraocular inflammation levels by laser flare photometry. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Endothelial cell density, as assessed by specular microscopy. - Pachymetry of the cornea measured using a Pentacam and/or an Anterior Segment Optical Coherence Tomography apparatus (AS-OCT). - Visual acuity, measured by the optometrist using a Snellen chart - Number of complications. | — |
Countries
The Netherlands