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A Comparison Between Full Thickness and Partial Thickness Corneal Transplantation for Corneal Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00346138
Recruitment Status : Completed
First Posted : June 29, 2006
Last Update Posted : January 15, 2010
Information provided by:
Mayo Clinic

Brief Summary:
The objectives of this study are to compare the visual and refractive outcomes of deep lamellar endothelial keratoplasty (DLEK) with penetrating keratoplasty as treatment for certain cases of corneal edema due to endothelial decompensation. Additionally, data will be collected to compare corneal shape, corneal thickness, endothelial cell density, keratocyte density, corneal sensitivity, light scatter, and subjective visual function between the two procedures.

Condition or disease Intervention/treatment Phase
Fuchs Dystrophy Corneal Edema Procedure: Corneal transplantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Deep Lamellar Endothelial Keratoplasty as Surgical Treatment for Corneal Endothelial Decompensation
Study Start Date : June 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Primary Outcome Measures :
  1. Visual acuity.

Secondary Outcome Measures :
  1. Astigmatism
  2. contrast sensitivity
  3. corneal haze
  4. endothelial cell density
  5. corneal thickness

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  1. Corneal edema due to endothelial dysfunction
  2. Aphakia, pseudophakia, or cataract requiring extraction
  3. Visual acuity in a) study eye; best spectacle-corrected entrance acuity 20/40 or worse. b)contralateral eye; best spectacle-corrected entrance acuity equal to or better than the study eye and 20/200 or better.

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 identifier (NCT number): NCT00346138

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00346138    
Other Study ID Numbers: 1000-03
First Posted: June 29, 2006    Key Record Dates
Last Update Posted: January 15, 2010
Last Verified: January 2010
Additional relevant MeSH terms:
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Corneal Edema
Fuchs' Endothelial Dystrophy
Signs and Symptoms
Corneal Diseases
Eye Diseases
Corneal Dystrophies, Hereditary
Eye Diseases, Hereditary
Genetic Diseases, Inborn