Cystoid Macular Edema, Fuchs Dystrophy
Conditions
Keywords
endothelial transplants, endothelial dysfunction
Brief summary
This study aims to evaluate and compare incidence of post-operative cystoid macular edema (CME) after Descemet Membrane Endothelial Keratoplasty (DMEK), Descemet's Stripping Automated endothelial Keratoplasty (DSEK) and Descemet Stripping Only (DSO).
Detailed description
Patients that are undergoing any of these procedures will be asked if they are willing to have a baseline pre-operative Optical Coherence Tomography (OCT) scan completed within 4 weeks of surgery. Additional OCT scans will be collected during routine follow up care. It is hypothesized that the rates of CME will be lower with DSO compared to DMEK and DSEK.
Interventions
DIAGNOSTIC_TESTOptical Coherence Tomography
OCT is an imaging method that uses light waves to create images of the retina.
Sponsors
Wake Forest University Health Sciences
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any patient that is undergoing DSO or endothelial corneal transplantation vis DMEK or DSEK
Exclusion criteria
* Patients that do not have an optical coherence tomography measurement pre- operatively * Patients that don't have an optical coherence tomography measurement post- operatively * Patients with a previous history of uncontrolled macular edema
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Post-Op CME | 6 weeks post-operative | The frequency (number of Subjects) of post-operative Cystoid Macular Edema will be evaluated for patients receiving DMEK, DSEK or DSO. |
| Severity of Post-Op CME | 6 weeks post-operative | The severity of post-operative Cystoid Macular Edema will be evaluated for patients receiving DMEK, DSEK or DSO that experience Cystoid Macular Edema after surgery - measured by net change of Central Foveal Thickness on Optical Coherence Tomography (OCT- is an imaging technique that uses low-coherence light to capture micrometer-resolution, two- and three-dimensional images from within optical scattering media, e.g., biological tissue) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graft Detachment | 6 weeks and 3 months post-operative | Frequency (number of Subjects) of post-operative graft detachment will be evaluated in patients that receive a corneal endothelial transplant. |
| Re-bubbling Procedure | 6 weeks and 3 months post-operative | The incidence (number of Subjects) of re-bubbling procedures performed post-operatively will be evaluated. |
| Infection | 6 weeks and 3 month post-operative | The incidence (number of Subjects) of post-operative infection will be evaluated. |
| Final Visual Acuity | 3 months post-operative | The Snellen Visual Acuity test - This means that the test subject sees the same line of letters at 20 feet that person with normal vision sees at 20 feet. 20/40 vision means that the test subject sees at 20 feet what a person with normal vision sees at 40 feet. |
Countries
United States
Outcome results
None listed