NCT00345020

Deep Lamellar Endothelial Keratoplasty: Small Incision Technique

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 95 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Corneal Transplantation

Interventions

Type	Name	Description
PROCEDURE	Deep Lamellar Endothelial Keratoplasty: Small Incision Technique

Timeline

• Start date: 2006-05-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2006-06-27
• Last updated: 2018-08-15

Locations

1 site across 1 country: United States