Early Experience With Descemet's Stripping Automated Endothelial Keratoplasty



Status:Completed
Conditions:Cardiology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:December 2006
End Date:December 2009
Contact:Janie Burroughs, BS
Email:Janie.Burroughs@UTSouthwestern.edu
Phone:214-645-2012

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Early Experience With Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) in Patients With Corneal Endothelial Cell Dysfunction: Clinical Outcomes and Diagnostic Imaging Analysis

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 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.

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.
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