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Early Experience With Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)

This study is currently recruiting participants.
Verified by University of Texas Southwestern Medical Center, August 2008

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
  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

MedlinePlus related topics:   Edema   

U.S. FDA Resources

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

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744796

Contacts
Contact: Janie Burroughs, BS     214-645-2012     Janie.Burroughs@UTSouthwestern.edu    
Contact: Mike Molai, BS     214-645-2014     Mike.Molai@UTSouthwestern.edu    

Locations
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            

Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigator initiated study

Investigators
Principal Investigator:     Vinod Mootha, MD     UTSW Medical Center at Dallas    
  More Information


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

Keywords provided by University of Texas Southwestern Medical Center:
Endothelial Dystrophy  
Fuchs' Endothelial Corneal Dystrophy  

Study placed in the following topic categories:
Corneal Diseases
Corneal dystrophy
Corneal Dystrophies, Hereditary
Eye Diseases
Fuchs' Endothelial Dystrophy
Corneal Edema
Neoplasm Metastasis
Chandler's syndrome
Edema

ClinicalTrials.gov processed this record on October 24, 2008




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