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

The University of Texas System (UT)

Status: Completed

Conditions: Corneal Edema Secondary to Corneal Endothelial Dystrophy

Treatments: Diagnostic Test: Best Spectacle Corrected Visual Acuity (BSCVA); Procedure: DSAEK; Diagnostic Test: Anterior Segment Optical Coherence Topography (OCT)

Study type: Observational

Funder types: Other

Identifiers

NCT00744796

102006-017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

21 participants in 1 patient group

DSAEK: Outcomes in patients with corneal edema

Description:

Best spectacle corrected visual acuity and anterior segment optical coherence tomography (OCT) at minimum will be performed in patients who have undergone DSAEK for corneal edema secondary to corneal endothelial dysfunction.

Treatment:

Procedure: DSAEK

Diagnostic Test: Anterior Segment Optical Coherence Topography (OCT)

Diagnostic Test: Best Spectacle Corrected Visual Acuity (BSCVA)