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PI does not have the time and support needed to continue the study at this time.
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical Coherence Tomography | Diagnostic Test | OCT is an imaging method that uses light waves to create images of the retina. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with endothelial dysfunction that require treatment, and are being evaluated for Descemet Stripping Only (DSO), Descemet Membrane Endothelial Keratoplasty (DMEK) or Descemet's Stripping Automated Endothelial Keratoplasty (DSEK)
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Giegengack | Wake Forest Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30973407 | Background | 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. | |
| 29298168 | Background | 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. |
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IPD will not be shared. Final, overall results will be reported for each outcome.
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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 |
| 25299425 | Background | 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. |
| 26186374 | Background | 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. |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D005642 | Fuchs' Endothelial Dystrophy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003317 | Corneal Dystrophies, Hereditary |
| D003316 | Corneal Diseases |
| D015785 | Eye Diseases, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |
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