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Study of Endothelial Keratoplasty Outcomes

This study is currently recruiting participants.
Verified August 2017 by Cornea Research Foundation of America
Sponsor:
ClinicalTrials.gov Identifier:
NCT00800111
First Posted: December 1, 2008
Last Update Posted: August 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Cornea Research Foundation of America
  Purpose

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 Intervention
Fuchs' Endothelial Corneal Dystrophy Bullous Keratopathy Iridocorneal Endothelial Syndrome Posterior Polymorphous Dystrophy Procedure: endothelial keratoplasty

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-enrollment, Prospective Study of Endothelial Keratoplasty Outcomes

Resource links provided by NLM:


Further study details as provided by Cornea Research Foundation of America:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 1, 3, 6, and 12 months and annually ]

Secondary Outcome Measures:
  • Endothelial cell density [ Time Frame: 6 months, 12 months and annually ]
  • Intraocular pressure [ Time Frame: 1, 3, 6, 12 months and annually ]
  • Manifest refraction [ Time Frame: 1, 3, 6, 12 months and annually ]
  • corneal pachymetry [ Time Frame: 1, 3, 6, 12 months and annually ]

Estimated Enrollment: 5000
Study Start Date: February 2008
Estimated Study Completion Date: February 2025
Estimated Primary Completion Date: February 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • DSAEK
  • DMEK

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800111


Contacts
Contact: Francis W Price, Jr., MD 317-814-2990 fprice@pricevisiongroup.net

Locations
United States, Indiana
Price Vision Group Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Francis W Price, Jr., MD         
Principal Investigator: Francis W Price, Jr., MD         
Sponsors and Collaborators
Cornea Research Foundation of America
Investigators
Principal Investigator: Francis W Price, Jr., MD Cornea Research Foundation of America
  More Information

Additional Information:
Publications:

Responsible Party: Cornea Research Foundation of America
ClinicalTrials.gov Identifier: NCT00800111     History of Changes
Other Study ID Numbers: CRFA2008-01
First Submitted: November 26, 2008
First Posted: December 1, 2008
Last Update Posted: August 10, 2017
Last Verified: August 2017

Keywords provided by Cornea Research Foundation of America:
failed penetrating keratoplasty

Additional relevant MeSH terms:
Fuchs' Endothelial Dystrophy
Iridocorneal Endothelial Syndrome
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Iris Diseases
Uveal Diseases