Descemet Membrane Endothelial Keratoplasty vs. Descemet's Stripping With Endothelial Keratoplasty vs. Descemet Stripping Only

Study Overview
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Brief Summary
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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
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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.

Official Title
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Incidence of Post-operative Cystoid Macular Edema: A Prospective Study Comparing DMEK, DSEK, and DSO

Conditions
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Cystoid Macular Edema, Fuchs Dystrophy

Intervention / Treatment
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* Diagnostic Test: Optical Coherence Tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endothelial Dysfunction Cohort<br>All patients enrolled in the study will receive a baseline Optical Coherence Tomography scan (OCT) within 4 weeks prior to surgery. Two additional OCT scan will be performed 6 weeks and 3 months after surgery. | Diagnostic Test: Optical Coherence Tomography<br>* OCT is an imaging method that uses light waves to create images of the retina.<br>* Other names: OCT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Post-Op CME | The frequency (number of Subjects) of post-operative Cystoid Macular Edema will be evaluated for patients receiving DMEK, DSEK or DSO. | 6 weeks post-operative | 
| Incidence of Post-Op CME | The frequency (number of Subjects) of post-operative Cystoid Macular Edema will be evaluated for patients receiving DMEK, DSEK or DSO. | 3 months post-operative | 
| Severity of Post-Op CME | 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) | 6 weeks post-operative | 
| Severity of Post-Op CME | 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) | 3 months post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft Detachment | Frequency (number of Subjects) of post-operative graft detachment will be evaluated in patients that receive a corneal endothelial transplant. | 6 weeks and 3 months post-operative | 
| Re-bubbling Procedure | The incidence (number of Subjects) of re-bubbling procedures performed post-operatively will be evaluated. | 6 weeks and 3 months post-operative | 
| Infection | The incidence (number of Subjects) of post-operative infection will be evaluated. | 6 weeks and 3 month post-operative | 
| Final Visual Acuity | 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. | 3 months post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endothelial transplants, endothelial dysfunction