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

NCT00346138 | Completed

• 1 other identifier: 1000-03
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Fuchs Dystrophy; Corneal Edema

Outcome Measures

Primary Outcomes (1)

• Visual acuity.

Secondary Outcomes (5)

• Astigmatism

• contrast sensitivity

• corneal haze

• endothelial cell density

• corneal thickness

Interventions

Corneal transplantation PROCEDURE

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (4)

• Trousdale ER, Hodge DO, Baratz KH, Maguire LJ, Bourne WM, Patel SV. Vision-related quality of life before and after keratoplasty for Fuchs' endothelial dystrophy. Ophthalmology. 2014 Nov;121(11):2147-52. doi: 10.1016/j.ophtha.2014.04.046. Epub 2014 Jul 9.

  PMID: 25015214 DERIVED

• 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.

  PMID: 22357383 DERIVED

• 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. doi: 10.1016/j.ajo.2008.12.039. Epub 2009 Mar 19.

  PMID: 19298950 DERIVED

• 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. doi: 10.1016/j.ajo.2007.09.002. Epub 2007 Nov 8.

  PMID: 17996211 DERIVED

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy; Corneal Edema

Interventions

Corneal Transplantation

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Transplantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 27, 2006
• First Posted: June 29, 2006
• Study Start: June 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: January 15, 2010

Record last verified: 2010-01

Locations

US (1)