Early Experience With Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)
Recruitment status was Recruiting
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Purpose
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Assess clinical outcomes in patients undergoing Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) for corneal edema secondary to corneal endothelial cell dysfunction [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
- Correlate clinical data with the latest generation of imaging modalities available for the anterior segment. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
| 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
|
Procedure: DSEAK
Endothelial Keratoplasty
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patients aged 18 and up, where any age over 89 will be recorded as 'greater than 89', who have reviewed and understood the study consent form will be invited to participate in this study.
- They will be recruited based on 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 at Dallas.
Exclusion Criteria:
- Patients younger than 18 years will not be considered for this trial.
- The study will include all patients (no exclusion criteria) who have undergone and will undergo DSAEK implantation for corneal edema secondary to corneal endothelial dystrophy with an effort to determine its success.
Contacts and Locations| 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 | |
| Principal Investigator: | Vinod Mootha, MD | UTSW Medical Center at Dallas |
More Information
No publications provided
| Responsible Party: | Vinod Mootha, MD, UTSW Medical Center at Dallas |
| ClinicalTrials.gov Identifier: | NCT00744796 History of Changes |
| Other Study ID Numbers: | 102006-017 |
| Study First Received: | August 29, 2008 |
| Last Updated: | August 29, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Texas Southwestern Medical Center:
|
Endothelial Dystrophy Fuchs' Endothelial Corneal Dystrophy |
Additional relevant MeSH terms:
|
Corneal Edema Edema Iridocorneal Endothelial Syndrome Corneal Diseases |
Eye Diseases Signs and Symptoms Iris Diseases Uveal Diseases |
ClinicalTrials.gov processed this record on June 17, 2013