Clinical Trial: A Comparison Between Full Thickness and Partial Thickness Corneal Transplantation for Corneal Edema

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Deep Lamellar Endothelial Keratoplasty as Surgical Treatment for Corneal Endothelial Decompensation

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.

Detailed Summary:

This will be a randomized prospective study. We will enroll patients using the following inclusion and exclusion criteria, based upon the surgeon?s initial complete ophthalmic examination, which includes refraction, keratometry, slit lamp examination, intraocular pressure and corneal thickness measurement, and dilated fundus examination.

Inclusion criteria:

1) Both males and females are eligible 2) Patient age 21 years or older 3) Corneal edema due to endothelial dysfunction 4) Aphakia, pseudophakia, or cataract requiring extraction 5) Visual acuity as measured in standardized fashion (ETDRS chart and appropriate illumination)

  1. Study eye; best spectacle-corrected entrance acuity 20/40 or worse

  2. Contralateral eye; best spectacle-corrected entrance acuity equal to or better than the study eye and 20/200 or better.

    Exclusion criteria:

    1) Central stromal corneal scars 2) Presence of a filtering bleb 3) History of Herpes simplex or Herpes zoster keratitis 4) Uncontrolled glaucoma 5) Pregnancy. Serum pregnancy testing will be performed within 7 days prior to surgery for women of child-bearing potential

    In the 2-year period, January 2001 to January 2003, 67 PK?s were performed at Mayo Clinic for endothelial dysfunction (e.g., Fuch?s dystrophy or pseudophakic corneal edema) in patients who met the entry criteria for this protocol. During the 2-year enrollment period of this study, we anticipate that up to 50 patients will be enrolled. Appropriate counseling will be done, including a discussion of the potential benefits and r
    Sponsor: Mayo Clinic

    Current Primary Outcome: Visual acuity.

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Astigmatism
    • contrast sensitivity
    • corneal haze
    • endothelial cell density
    • corneal thickness


    Original Secondary Outcome: Same as current

    Information By: Mayo Clinic

    Dates:
    Date Received: June 27, 2006
    Date Started: June 2005
    Date Completion:
    Last Updated: January 14, 2010
    Last Verified: January 2010