Skip to main content
OpenTrials
Completed

NCT Number: NCT00744796

Early Experience With Descemet's Stripping Automated Endothelial Keratoplasty

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UT Southwestern Medical Center - Aston Ambulatory Clinic

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DSAEK

Procedure

Endothelial Keratoplasty

Anterior Segment Optical Coherence Topography (OCT)

Diagnostic Test

Non-contact, high resolution, cross sectional imaging of the anterior segment of the eye.

Best Spectacle Corrected Visual Acuity (BSCVA)

Diagnostic Test

Visual acuity determined using a combination of detecting hand motion, counting fingers displayed and reading Snellen charts at specific distances.

Primary outcomes

  1. Best Spectacle Corrected Visual Acuity (BSCVA)

    Time frame: 6-9 months Post-Operative

    Best spectacle corrected visual acuity determined using detection of hand motion, counting of displayed fingers and accuracy of Snellen chart reading at specified distances.

  2. Central Corneal Thickness

    Time frame: 6 to 9 Months Post-Operative

    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.

  3. Peripheral Corneal Thickness

    Time frame: 6 to 9 Months Post-Operative

    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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Acronym: DSAEK

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Sep 1, 2008
Registry last updated
Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.