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Deep Lamellar Endothelial Keratoplasty: Small Incision Technique

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ClinicalTrials.gov Identifier: NCT00345020
Recruitment Status : Completed
First Posted : June 27, 2006
Last Update Posted : June 23, 2008
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center

Brief 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.

Condition or disease Intervention/treatment
Corneal Transplantation Procedure: Deep Lamellar Endothelial Keratoplasty: Small Incision Technique

Detailed 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.

Study Type : Observational
Actual Enrollment : 0 participants
Official Title: Deep Lamellar Endothelial Keratoplasty: Small Incision Technique
Study Start Date : May 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006



Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   21 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00345020


Locations
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-8866
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Vinod Mootha, M.D. University of Texas, Southwestern Medical Center at Dallas

Responsible Party: Vinod Mootha, MD, UTSW Medical Center at Dallas
ClinicalTrials.gov Identifier: NCT00345020     History of Changes
Other Study ID Numbers: 032005-027
First Posted: June 27, 2006    Key Record Dates
Last Update Posted: June 23, 2008
Last Verified: May 2007

Keywords provided by University of Texas Southwestern Medical Center:
Deep Lamellar Endotheliam Keratoplasty