Deep Lamellar Endothelial Keratoplasty: Small Incision Technique
| Tracking Information | |||||
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| First Received Date ICMJE | June 23, 2006 | ||||
| Last Updated Date | June 19, 2008 | ||||
| Start Date ICMJE | May 2006 | ||||
| Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00345020 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Deep Lamellar Endothelial Keratoplasty: Small Incision Technique | ||||
| Official Title ICMJE | Deep Lamellar Endothelial Keratoplasty: Small Incision Technique | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Not Provided | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE | Corneal Transplantation | ||||
| Intervention ICMJE | Procedure: Deep Lamellar Endothelial Keratoplasty: Small Incision Technique | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 0 | ||||
| Completion Date | December 2006 | ||||
| Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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. - |
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| Gender | Both | ||||
| Ages | 21 Years to 95 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00345020 | ||||
| Other Study ID Numbers ICMJE | 032005-027 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Vinod Mootha, MD, UTSW Medical Center at Dallas | ||||
| Study Sponsor ICMJE | University of Texas Southwestern Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Texas Southwestern Medical Center | ||||
| Verification Date | May 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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