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

This study has been completed.
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
First received: June 27, 2006
Last updated: January 14, 2010
Last verified: January 2010
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: 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)
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Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00346138

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00346138     History of Changes
Other Study ID Numbers: 1000-03 
Study First Received: June 27, 2006
Last Updated: January 14, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Corneal Edema
Fuchs' Endothelial Dystrophy
Corneal Diseases
Corneal Dystrophies, Hereditary
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 25, 2016