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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00346138
First Posted: June 29, 2006
Last Update Posted: January 15, 2010
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.
Information provided by:
Mayo Clinic
  Purpose
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 Intervention
Fuchs Dystrophy Corneal Edema Procedure: Corneal transplantation

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Visual acuity.

Secondary Outcome Measures:
  • Astigmatism
  • contrast sensitivity
  • corneal haze
  • endothelial cell density
  • corneal thickness

Enrollment: 29
Study Start Date: June 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  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.
  Contacts and Locations
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): NCT00346138


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
  More Information
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