Early Experience With Descemet's Stripping Automated Endothelial Keratoplasty

NCT00744796 | Completed Results

• 1 other identifier: 102006-017
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Corneal Edema Secondary to Corneal Endothelial Dystrophy

Keywords

Endothelial Dystrophy; Fuchs' Endothelial Corneal Dystrophy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

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.

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

Interventions

DSAEK PROCEDURE

Endothelial Keratoplasty

DSAEK: Outcomes in patients with corneal edema

Anterior Segment Optical Coherence Topography (OCT) DIAGNOSTIC_TEST

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

DSAEK: Outcomes in patients with corneal edema

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.

DSAEK: Outcomes in patients with corneal edema

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients younger than 18 years will not be considered for this trial.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center - Aston Ambulatory Clinic

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Vinod Mootha
• Organization: University of Texas Southwestern Medical Center

peter.chen@utsouthwestern.edu

214-648-3837

Study Officials

• Vinod Mootha, MD

  UTSW Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty Sponsor

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 1, 2008
• Study Start: December 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2009
• Last Updated: December 11, 2020
• Results First Posted: December 11, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)