An observational study in Cystoid Macular Edema and Fuchs Dystrophy, sponsored by Wake Forest University Health Sciences. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-13.
Sponsored by Wake Forest University Health Sciences · Observational
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.
756 studies on the registry are indexed under Macular Edema; 65 are open to participants now.
This study's enrollment of 4 is below the median of 71 across 127 observational studies indexed under Macular Edema.
Browse Macular Edema studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
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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)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Also known as: OCT
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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 3 months post-operative
Graft Detachment
Frequency (number of Subjects) of post-operative graft detachment will be evaluated in patients that receive a corneal endothelial transplant.
Time frame: 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.
Time frame: 6 weeks and 3 months post-operative
Infection
The incidence (number of Subjects) of post-operative infection will be evaluated.
Time frame: 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.
Time frame: 3 months post-operative
Plan to share: No — IPD will not be shared. Final, overall results will be reported for each outcome.
Ran from Nov 2020 to primary completion in Aug 2022, 21 months.
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This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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