Study of Endothelial Keratoplasty Outcomes

Cornea Research Foundation of America (Other)
Overall Status
Completed ID

Study Details

Study Description

Brief Summary

Endothelial keratoplasty is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. This technique offers many advantages compared with traditional full-thickness cornea transplants. Patients experience minimal change in glasses prescription and usually recover useful vision within weeks. Visual fluctuations are minimal during the healing process. The patient's cornea remains structurally intact and is more resistant to injury.

Endothelial keratoplasty is undergoing rapid and widespread adoption. Between 2005 and 2007, the number of corneas placed by US eye banks for endothelial keratoplasty increased ten-fold (2007 Eye Bank Association of America Annual Report). However, the procedure is less than 10 years old, and little is known about long term outcomes. Endothelial keratoplasty candidates at our center are invited to participate in an open enrollment, prospective study of the long-term outcomes of this procedure.

Condition or Disease Intervention/Treatment Phase
  • Procedure: endothelial keratoplasty

Study Design

Study Type:
Actual Enrollment :
2593 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Open-enrollment, Prospective Study of Endothelial Keratoplasty Outcomes
Study Start Date :
Feb 1, 2008
Actual Primary Completion Date :
Feb 1, 2018
Actual Study Completion Date :
Feb 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: Treatment

Endothelial keratoplasty procedure is performed.

Procedure: endothelial keratoplasty
Endothelial keratoplasty is surgical replacement of the corneal endothelial cell layer (the cell layer lining the inner surface of the cornea).
Other Names:
  • Descemet stripping endothelial keratoplasty
  • Descemet stripping automated endothelial keratoplasty
  • Descemet membrane endothelial keratoplasty
  • DSEK
  • DMEK
  • Outcome Measures

    Primary Outcome Measures

    1. Visual acuity [1, 3, 6, and 12 months and annually]

    Secondary Outcome Measures

    1. Endothelial cell density [6 months, 12 months and annually]

    2. Intraocular pressure [1, 3, 6, 12 months and annually]

    3. Manifest refraction [1, 3, 6, 12 months and annually]

    4. corneal pachymetry [1, 3, 6, 12 months and annually]

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • Male or female aged 18 or older

    • Scheduled to undergo endothelial keratoplasty

    • Able to provide written informed consent.

    Exclusion Criteria:
    • Age less than 18 years

    Contacts and Locations


    Site City State Country Postal Code
    1 Price Vision Group Indianapolis Indiana United States 46260

    Sponsors and Collaborators

    • Cornea Research Foundation of America


    • Principal Investigator: Francis W Price, Jr., MD, Cornea Research Foundation of America

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:


    Responsible Party:
    Cornea Research Foundation of America Identifier:
    Other Study ID Numbers:
    • CRFA2008-01
    First Posted:
    Dec 1, 2008
    Last Update Posted:
    Jan 23, 2019
    Last Verified:
    Jan 1, 2019
    Keywords provided by Cornea Research Foundation of America
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 23, 2019