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Early Experience With Descemet's Stripping Automated Endothelial Keratoplasty

NCT ID: NCT00744796

Last Updated: 2020-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Corneal Edema Secondary to Corneal Endothelial Dystrophy

Keywords

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Endothelial Dystrophy Fuchs' Endothelial Corneal Dystrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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DSAEK: Outcomes in patients with corneal edema

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.

DSAEK

Intervention Type PROCEDURE

Endothelial Keratoplasty

Anterior Segment Optical Coherence Topography (OCT)

Intervention Type DIAGNOSTIC_TEST

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

Best Spectacle Corrected Visual Acuity (BSCVA)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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DSAEK

Endothelial Keratoplasty

Intervention Type PROCEDURE

Anterior Segment Optical Coherence Topography (OCT)

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

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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V. Vinod Mootha

Faculty Sponsor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vinod Mootha, MD

Role: PRINCIPAL_INVESTIGATOR

UTSW Medical Center at Dallas

Locations

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UT Southwestern Medical Center - Aston Ambulatory Clinic

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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102006-017

Identifier Type: -

Identifier Source: org_study_id