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The purpose of this study is to report the early clinical outcomes in patients undergoing Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) for corneal edema secondary to corneal endothelial cell dysfunction, and to correlate this clinical data with the latest generation of imaging modalities available for the anterior segment.
A concurrent study for retrospective as well as prospective cases of patients undergoing DSAEK procedures for indication of corneal endothelial cell dysfunction. For the retrospective study, all cases of DSAEK procedures performed at UT-Southwestern for corneal edema secondary to endothelial cell dysfunction will be considered. The clinical outcomes of these surgeries will be analyzed and correlated with the anterior segment imaging from each case. Statistical analysis will then be performed on the data collected. For the prospective arm of this trial, we propose to recruit up to 200 current patient cases of corneal edema second corneal endothelial cell dysfunction. These patients will undergo ocular imaging studies in addition to routine ocular exams performed before surgery and at the discretion of the investigational physician at 3 to 6-months and 6 to 9-months after surgical treatment. Various imaging modalities would include corneal topography, pentacam, anterior segment OCT, wavefront measurement and Tandem Scanning Confocal Microscopy (TSCM). The patients who have already had the DSAEK procedure done in the past will undergo ocular examination as well as various imaging studies at their post op follow up visits. All these modalities are routinely used as standard of care practice and are non-invasive. The data from the ocular examination and various imaging techniques will be pooled and analyzed at the end of the study in order to identify the factors that influence the visual outcome. We believe this will help us learn more about this interesting and innovative technique while at the same time help us improve the method further in order to obtain better results in future patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSAEK: Outcomes in patients with corneal edema | Best spectacle corrected visual acuity and anterior segment optical coherence tomography (OCT) at minimum will be performed in patients who have undergone DSAEK for corneal edema secondary to corneal endothelial dysfunction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSAEK | Procedure | Endothelial Keratoplasty |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Best Spectacle Corrected Visual Acuity (BSCVA) | Best spectacle corrected visual acuity determined using detection of hand motion, counting of displayed fingers and accuracy of Snellen chart reading at specified distances. | 6-9 months Post-Operative |
| Central Corneal Thickness | The central corneal thickness was determined manually by a single investigator from optical coherence tomography (OCT) measurements. A horizontal cross-sectional image with good central reflective light representing the anterior corneal vertex was used. | 6 to 9 Months Post-Operative |
| Peripheral Corneal Thickness | Peripheral corneal thickness was determined manually by a single investigator using the mean of 2 measurements taken by OCT 3.5 mm from the center of the cornea. | 6 to 9 Months Post-Operative |
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Inclusion Criteria:
Exclusion Criteria:
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All patients 18 years or older with a clinical diagnosis of corneal edema secondary to endothelial cell dysfunction undergoing DSAEK either alone or in conjunction with phacoemulsification and intraocular lens implantation at the University of Texas Southwestern Medical Center between May, 2006 and July, 2007.
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| Name | Affiliation | Role |
|---|---|---|
| Vinod Mootha, MD | UTSW Medical Center at Dallas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center - Aston Ambulatory Clinic | Dallas | Texas | 75390 | United States |
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Twenty one patients from UT Southwestern Medical Center's Ophthalmology clinic were included.
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| ID | Title | Description |
|---|---|---|
| FG000 | DSAEK Group | Patients who have corneal dystrophy and have elected to have DSAEK performed on his/her eye(s). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Pre-operative |
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| Anterior Segment Optical Coherence Topography (OCT) |
| Diagnostic Test |
Non-contact, high resolution, cross sectional imaging of the anterior segment of the eye. |
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| Best Spectacle Corrected Visual Acuity (BSCVA) | Diagnostic Test | Visual acuity determined using a combination of detecting hand motion, counting fingers displayed and reading Snellen charts at specific distances. |
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| COMPLETED |
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| NOT COMPLETED |
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| Post-Operative Day 1 |
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| Post-Operative 3-6 Months |
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| Post-Operative 6-9 Months |
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| ID | Title | Description |
|---|---|---|
| BG000 | DSAEK Group | Patients who have corneal dystrophy and have elected to have DSAEK performed on his/her eye(s). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Participants in Study | Count of Participants | Participants |
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| Sex/Gender, Customized | Collecting the gender information amongst all participants. | Count of Participants | Participants |
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| Best-Spectacle Corrected Visual Acuity (BSCVA) | Detection of hand motion, counting of fingers displayed and Snellen chart reading accuracy were used. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Best Spectacle Corrected Visual Acuity (BSCVA) | Best spectacle corrected visual acuity determined using detection of hand motion, counting of displayed fingers and accuracy of Snellen chart reading at specified distances. | The number of participant, for analysis, were determined per protocol. | Posted | Count of Participants | Participants | 6-9 months Post-Operative |
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| Primary | Central Corneal Thickness | The central corneal thickness was determined manually by a single investigator from optical coherence tomography (OCT) measurements. A horizontal cross-sectional image with good central reflective light representing the anterior corneal vertex was used. | Posted | Mean | Standard Deviation | micrometer | 6 to 9 Months Post-Operative |
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| Primary | Peripheral Corneal Thickness | Peripheral corneal thickness was determined manually by a single investigator using the mean of 2 measurements taken by OCT 3.5 mm from the center of the cornea. | Posted | Mean | Standard Deviation | micrometer | 6 to 9 Months Post-Operative |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DSAEK Group | Patients who have corneal dystrophy and have elected to have DSAEK performed on his/her eye(s). | 0 | 21 | 0 | 21 | 0 | 21 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vinod Mootha | University of Texas Southwestern Medical Center | 214-648-3837 | peter.chen@utsouthwestern.edu |
| ID | Term |
|---|---|
| D005642 | Fuchs' Endothelial Dystrophy |
| ID | Term |
|---|---|
| D003317 | Corneal Dystrophies, Hereditary |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Title | Measurements |
|---|---|
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| Snellen fraction < or = 20/20 and >20/50 |
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| Hand Motion only |
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| Finger Count only |
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| Title | Measurements |
|---|---|
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| Snellen fraction < or = 20/50 and >20/200 |
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| Snellen fraction < or = 20/20 and >20/50 |
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