Deep Lamellar Endothelial Keratoplasty: Small Incision Technique

Study Overview
=================
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.

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.

Official Title
-----------------
Deep Lamellar Endothelial Keratoplasty: Small Incision Technique

Conditions
-----------------
Corneal Transplantation

Intervention / Treatment
-----------------
* Procedure: Deep Lamellar Endothelial Keratoplasty: Small Incision Technique


Participation Criteria
=================
Eligibility 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. -

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 95 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Deep Lamellar Endothelial Keratoplasty: Small Incision Technique|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Deep Lamellar Endotheliam Keratoplasty