Descemet Membrane Endothelial Keratoplasty vs. Descemet's Stripping With Endothelial Keratoplasty vs. Descemet Stripping Only
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Endothelial Dysfunction Cohort 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
OCT is an imaging method that uses light waves to create images of the retina.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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.
- Incidence of Post-Op CME [3 months 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)
- Severity of Post-Op CME [3 months 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Any patient that is undergoing DSO or endothelial corneal transplantation vis DMEK or DSEK
Exclusion Criteria:
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Patients that do not have an optical coherence tomography measurement pre- operatively
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Patients that don't have an optical coherence tomography measurement post- operatively
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Patients with a previous history of uncontrolled macular edema
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Matthew Giegengack, Wake Forest Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
- Arbelaez JG, Price MO, Price FW Jr. Long-term follow-up and complications of stripping descemet membrane without placement of graft in eyes with Fuchs endothelial dystrophy. Cornea. 2014 Dec;33(12):1295-9. doi: 10.1097/ICO.0000000000000270.
- Inoda S, Hayashi T, Takahashi H, Oyakawa I, Yokogawa H, Kobayashi A, Kato N, Kawashima H. Risk Factors for Cystoid Macular Edema After Descemet Membrane Endothelial Keratoplasty. Cornea. 2019 Jul;38(7):820-824. doi: 10.1097/ICO.0000000000001950.
- Kocaba V, Mouchel R, Fleury J, Marty AS, Janin-Manificat H, Maucort-Boulch D, Burillon C. Incidence of Cystoid Macular Edema After Descemet Membrane Endothelial Keratoplasty. Cornea. 2018 Mar;37(3):277-282. doi: 10.1097/ICO.0000000000001501.
- Koenig SB. Planned Descemetorhexis Without Endothelial Keratoplasty in Eyes With Fuchs Corneal Endothelial Dystrophy. Cornea. 2015 Sep;34(9):1149-51. doi: 10.1097/ICO.0000000000000531.
- IRB00067948