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

This study has been completed.

Sponsor:

Information provided by:

Mayo Clinic

ClinicalTrials.gov Identifier:

NCT00346138

First received: June 27, 2006

Last updated: January 14, 2010

Last verified: January 2010

History of Changes

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: Open Label Primary Purpose: Treatment
Official Title:	Deep Lamellar Endothelial Keratoplasty as Surgical Treatment for Corneal Endothelial Decompensation

Resource links provided by NLM:

Genetics Home Reference related topics: Fuchs endothelial dystrophy lattice corneal dystrophy type I Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome

MedlinePlus related topics: Edema

U.S. FDA Resources

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

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
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

More Information

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ahuja Y, Baratz KH, McLaren JW, Bourne WM, Patel SV. Decreased corneal sensitivity and abnormal corneal nerves in Fuchs endothelial dystrophy. Cornea. 2012 Nov;31(11):1257-63. doi: 10.1097/ICO.0b013e31823f7888.

McLaren JW, Patel SV, Bourne WM, Baratz KH. Corneal wavefront errors 24 months after deep lamellar endothelial keratoplasty and penetrating keratoplasty. Am J Ophthalmol. 2009 Jun;147(6):959-65, 965.e1-2. Epub 2009 Mar 19.

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.

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
Edema
Fuchs' Endothelial Dystrophy
Corneal Diseases
Eye Diseases

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

ClinicalTrials.gov processed this record on May 23, 2013

To Top