- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00744796
Early Experience With Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)
November 17, 2020 updated by: V. Vinod Mootha, University of Texas Southwestern Medical Center
Early Experience With Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) in Patients With Corneal Endothelial Cell Dysfunction: Clinical Outcomes and Diagnostic Imaging Analysis
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.
Study Overview
Status
Completed
Detailed 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.
Study Type
Observational
Enrollment (Actual)
21
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Dallas, Texas, United States, 75390
- UT Southwestern Medical Center - Aston Ambulatory Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All patients 18 years or older with a clinical 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 between May, 2006 and July, 2007.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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Endothelial Keratoplasty
Non-contact, high resolution, cross sectional imaging of the anterior segment of the eye.
Visual acuity determined using a combination of detecting hand motion, counting fingers displayed and reading Snellen charts at specific distances.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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6-9 months Post-Operative
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Central Corneal Thickness
Time Frame: 6 to 9 Months Post-Operative
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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.
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6 to 9 Months Post-Operative
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Peripheral Corneal Thickness
Time Frame: 6 to 9 Months Post-Operative
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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.
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6 to 9 Months Post-Operative
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (ACTUAL)
July 1, 2008
Study Completion (ACTUAL)
July 1, 2009
Study Registration Dates
First Submitted
August 29, 2008
First Submitted That Met QC Criteria
August 29, 2008
First Posted (ESTIMATE)
September 1, 2008
Study Record Updates
Last Update Posted (ACTUAL)
December 11, 2020
Last Update Submitted That Met QC Criteria
November 17, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 102006-017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Corneal Edema Secondary to Corneal Endothelial Dystrophy
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EmmecellRecruitingEndothelial Dysfunction | Corneal Edema | Fuchs Dystrophy | Corneal Endothelial Dystrophy | Bullous Keratopathy | Pseudophakic Bullous Keratopathy | Corneal Endothelial Dysfunction | Fuchs Endothelial Corneal Dystrophy | Moderate Corneal Endothelial DecompensationUnited States
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Asociación para Evitar la Ceguera en MéxicoEmmecellRecruitingEndothelial Dysfunction | Corneal Edema | Fuchs' Endothelial Dystrophy | Fuchs Dystrophy | Corneal Endothelial Dystrophy | Bullous Keratopathy | Pseudophakic Bullous Keratopathy | Corneal Edema PseudophakicMexico
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Valeria Sanchez-HuertaEmmecellUnknownCorneal Edema | Fuchs' Endothelial Dystrophy | Fuchs Dystrophy | Corneal Endothelial Dystrophy | Pseudophakic Bullous Keratopathy | Corneal Transplant FailureMexico
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Price Vision GroupKala Pharmaceuticals, Inc.CompletedCorneal Edema | Corneal Endothelial DystrophyUnited States
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Aerie PharmaceuticalsCompleted
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National Eye Institute (NEI)Bausch & Lomb Incorporated; Eye Bank Association of America; Midwest Eye Banks; Tissue Banks International and other collaboratorsCompletedCorneal Disease | Fuch's Dystrophy | Pseudophakic Corneal EdemaUnited States
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Legacy Health SystemDevers Eye Institute; Lions Eye Bank of Oregon Vision Research Laboratory; Fischer...UnknownFuchs' Corneal Endothelial DystrophyUnited States
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Trefoil Therapeutics, Inc.CompletedEndothelial Dysfunction | Corneal Endothelial Dystrophy | Pseudophakic Bullous Keratopathy | Fuchs Endothelial Corneal DystrophyUnited States
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Kowa Research Institute, Inc.CompletedFuchs' Endothelial Corneal DystrophyUnited States, Australia, Germany, Spain, Denmark
-
Centre Hospitalier Universitaire de Saint EtienneKyoto University, Graduate School of MedicineCompletedFuchs Endothelial Corneal DystrophyFrance
Clinical Trials on DSAEK
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Oregon Health and Science UniversityTerminated
-
Maastricht University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompleted
-
Centre Hospitalier Régional Metz-ThionvilleCompletedCorneal Transplant
-
Universität des SaarlandesCharite University, Berlin, Germany; University of Erlangen-Nürnberg; University... and other collaboratorsCompletedCorneal TransplantationGermany
-
University of AarhusActive, not recruitingFuchs' Endothelial DystrophyDenmark
-
Eye-yon MedicalActive, not recruitingCorneal EdemaIsrael, Georgia, Germany, India, France, Netherlands
-
EDUARD PEDEMONTE-SARRIASCompletedFuchs' Endothelial Dystrophy | Corneal Endothelial Cell LossSpain
-
Aarhus University HospitalCompletedFuchs' Endothelial Corneal DystrophyDenmark
-
Netherlands Institute for Innovative Ocular SurgeryAmnitrans Eyebank Rotterdam; Melles CorneaClinic RotterdamCompletedCorneal Dystrophies, HereditaryNetherlands
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Cornea Research Foundation of AmericaCompletedBullous Keratopathy | Fuchs' Endothelial Corneal Dystrophy | Iridocorneal Endothelial Syndrome | Posterior Polymorphous DystrophyUnited States