Trial record 19 of 19 for:    "Fuchs endothelial dystrophy" OR "Corneal Granular Dystrophies" OR "Hereditary Corneal Dystrophies" OR "Corneal Macular Dystrophy"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Investigator initiated study
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00744796
First received: August 29, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Iridocorneal Endothelial Syndrome
Corneal Diseases
Eye Diseases
Iris Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on July 23, 2014