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

This study is currently recruiting participants.

Verified by Mayo Clinic, June 2006

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00346138

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
Fuch's Dystrophy Corneal Edema	Procedure: Corneal transplantation

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome

MedlinePlus related topics: Edema

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment
Official Title:	Deep Lamellar Endothelial Keratoplasty as Surgical Treatment for Corneal Endothelial Decompensation

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

Estimated Enrollment:	50
Study Start Date:	June 2005

Show Detailed Description

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Corneal edema due to endothelial dysfunction
Aphakia, pseudophakia, or cataract requiring extraction
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346138

Locations

United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Keith H. Baratz, M.D. baratz.keith@mayo.edu
Principal Investigator: Keith H. Baratz, M.D.

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

Keith H. Baratz, M.D.

Mayo Clinic

More Information

Publications indexed to this study:

Patel SV, McLaren JW, Hodge DO, Baratz KH. Scattered light and visual function in a randomized trial of deep lamellar endothelial keratoplasty and penetrating keratoplasty. Am J Ophthalmol. 2008 Jan;145(1):97-105. Epub 2007 Nov 8.

Study ID Numbers:	1000-03
Study First Received:	June 27, 2006
Last Updated:	June 27, 2006
ClinicalTrials.gov Identifier:	NCT00346138
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Signs and Symptoms
Corneal Diseases
Corneal dystrophy
Genetic Diseases, Inborn
Corneal Dystrophies, Hereditary
Eye Diseases

Corneal dystrophy, Fuchs' endothelial, 1
Fuchs' Endothelial Dystrophy
Corneal Edema
Eye Diseases, Hereditary
Edema

ClinicalTrials.gov processed this record on January 14, 2009