Early Experience With Descemet's Stripping Automated Endothelial Keratoplasty

Corneal Edema Secondary to Corneal Endothelial Dystrophy Clinical Trial

— DSAEK  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00744796
• Other study ID #: 102006-017
• Status: Completed
• Start date: December 2006
• Est. completion date: July 2009

Study information

• Verified date: November 2020
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

A concurrent study for retrospective as well as 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. 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 3 to 6-months and 6 to 9-months 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Edema
• Corneal Edema Secondary to Corneal Endothelial Dystrophy

Intervention

Procedure:
• DSAEK
Endothelial Keratoplasty

Diagnostic Test:
• Anterior Segment Optical Coherence Topography (OCT)
Non-contact, high resolution, cross sectional imaging of the anterior segment of the eye.
• Best Spectacle Corrected Visual Acuity (BSCVA)
Visual acuity determined using a combination of detecting hand motion, counting fingers displayed and reading Snellen charts at specific distances.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center - Aston Ambulatory Clinic	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Spectacle Corrected Visual Acuity (BSCVA)	Best spectacle corrected visual acuity determined using detection of hand motion, counting of displayed fingers and accuracy of Snellen chart reading at specified distances.	6-9 months Post-Operative
Primary	Central Corneal Thickness	The central corneal thickness was determined manually by a single investigator from optical coherence tomography (OCT) measurements. A horizontal cross-sectional image with good central reflective light representing the anterior corneal vertex was used.	6 to 9 Months Post-Operative
Primary	Peripheral Corneal Thickness	Peripheral corneal thickness was determined manually by a single investigator using the mean of 2 measurements taken by OCT 3.5 mm from the center of the cornea.	6 to 9 Months Post-Operative