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NCT00345020 Clinical Trial

Deep Lamellar Endothelial Keratoplasty: Small Incision Technique

Corneal Transplantation Clinical Trial

Official title:
Deep Lamellar Endothelial Keratoplasty: Small Incision Technique

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00345020
Other study ID # 032005-027
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date May 2006
Est. completion date December 2006

Study information
Verified date August 2018
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The research objectives of this study are to determine if small incision Deep Lamellar Endothelial Keratoplasty (DLEK) is able to further reduce the degree of corneal astigmatism and shorten the time course of corneal topography stabilization compared to standard full thickness corneal transplant (PKP) surgery.

Description:

Split thickness lamellar corneal transplants have been performed for many years to replace the front part of the cornea and have been highly successful. What is different about this study is that the surgical procedure involves replacement of the back layers of the cornea rather than the front layers of the cornea. This replacement is done through a small pocket incision to avoid changes in the front surface of the cornea. By leaving the front surface in the cornea without sutures or incisions there is felt to be an advantage in healing and recovery time for the patient. In addition, this particular study will use a pocket incision that is even shorter and smaller in length than the one used in previous DLEK surgeries to try to make healing time even faster and more predictable. This procedure has been successfully performed on patients in the Netherlands for over five years. The procedure has also been successfully performed by doctors in the United States. Subjects participating in this study will be among the first patients to undergo this procedure in the The University of Texas Southwestern Medical Center at Dallas.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2006
Est. primary completion date December 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 95 Years
Eligibility Inclusion Criteria: Subjects enrolled in this study will have endothelial dysfunction to a level generally accepted as requiring standard PKP for treatment. Subjects will be offered the alternative surgery of this protocol. All subjects will be between the ages of 21 and 95. Males and females are eligible.

Exclusion Criteria: Central corneal scars, presence of a filtering bleb and uncontrolled glaucoma.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Deep Lamellar Endothelial Keratoplasty: Small Incision Technique

Locations
Country Name City State
United States University of Texas Southwestern Medical Center at Dallas Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary to determine if small incision Deep Lamellar Endothelial Keratoplasty (DLEK) is able to further reduce the degree of corneal astigmatism and shorten the time course of corneal topography stabilization
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