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Sponsors and Collaborators: |
University of Texas Southwestern Medical Center Investigator initiated study |
Information provided by: | University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00744796 |
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.
Condition | Intervention |
Corneal Edema Secondary to Corneal Endothelial Dystrophy |
Procedure: DSEAK |
MedlinePlus related topics: | Edema |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Early Experience With Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) in Patients With Corneal Endothelial Cell Dysfunction: Clinical Outcomes and Diagnostic Imaging Analysis |
Estimated Enrollment: | 200 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
D
Not a comparative group. Assessing single group
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Procedure: DSEAK
Endothelial Keratoplasty
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A concurrent study in which a retrospective as well as a 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. And 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 6-month and 12-month 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Janie Burroughs, BS | 214-645-2012 | Janie.Burroughs@UTSouthwestern.edu |
Contact: Mike Molai, BS | 214-645-2014 | Mike.Molai@UTSouthwestern.edu |
United States, Texas | |||||
UTSW Medical Center at Dalla - Aston Ambulatory Clinic | Recruiting | ||||
Dallas, Texas, United States, 75390 | |||||
Contact: Janie Burroughs, BS 214-645-2012 Janie.Burroughs@UTSouthwestern.edu | |||||
Contact: Mike Molai, BS 214-645-2014 Mike.Molai@UTSouthwestern.edu | |||||
Principal Investigator: Vinod Mootha, MD | |||||
Sub-Investigator: Pawan Prasher, MD |
University of Texas Southwestern Medical Center |
Investigator initiated study |
Principal Investigator: | Vinod Mootha, MD | UTSW Medical Center at Dallas |
Responsible Party: | UTSW Medical Center at Dallas ( Vinod Mootha, MD ) |
Study ID Numbers: | 102006-017 |
First Received: | August 29, 2008 |
Last Updated: | August 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00744796 |
Health Authority: | United States: Institutional Review Board |
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