Study of Endothelial Keratoplasty Outcomes

January 21, 2019 updated by: Cornea Research Foundation of America

Open-enrollment, Prospective Study of Endothelial Keratoplasty Outcomes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2593

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Price Vision Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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:
  • DSAEK
  • DMEK
  • DSEK
  • Descemet stripping endothelial keratoplasty
  • Descemet stripping automated endothelial keratoplasty
  • Descemet membrane endothelial keratoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual acuity
Time Frame: 1, 3, 6, and 12 months and annually
1, 3, 6, and 12 months and annually

Secondary Outcome Measures

Outcome Measure
Time Frame
Endothelial cell density
Time Frame: 6 months, 12 months and annually
6 months, 12 months and annually
Intraocular pressure
Time Frame: 1, 3, 6, 12 months and annually
1, 3, 6, 12 months and annually
Manifest refraction
Time Frame: 1, 3, 6, 12 months and annually
1, 3, 6, 12 months and annually
corneal pachymetry
Time Frame: 1, 3, 6, 12 months and annually
1, 3, 6, 12 months and annually

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cornea Research Foundation of America

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ACTUAL)

February 1, 2018

Study Completion (ACTUAL)

February 1, 2018

Study Registration Dates

First Submitted

November 26, 2008

First Submitted That Met QC Criteria

November 28, 2008

First Posted (ESTIMATE)

December 1, 2008

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 21, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRFA2008-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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