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Study of Endothelial Keratoplasty Outcomes

This study is currently recruiting participants.
Verified May 2013 by Cornea Research Foundation of America
Sponsor:
Information provided by (Responsible Party):
Cornea Research Foundation of America
ClinicalTrials.gov Identifier:
NCT00800111
First received: November 26, 2008
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  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: Open Label
Primary Purpose: Treatment
Official Title: Open-enrollment, Prospective Study of Endothelial Keratoplasty Outcomes

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endothelial cell density [ Time Frame: 6 months, 12 months and annually ] [ Designated as safety issue: No ]
  • Intraocular pressure [ Time Frame: 1, 3, 6, 12 months and annually ] [ Designated as safety issue: Yes ]
  • Manifest refraction [ Time Frame: 1, 3, 6, 12 months and annually ] [ Designated as safety issue: No ]
  • corneal pachymetry [ Time Frame: 1, 3, 6, 12 months and annually ] [ Designated as safety issue: No ]

Estimated Enrollment: 4000
Study Start Date: February 2008
Estimated Primary Completion Date: February 2018 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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            
United States, Washington
Art Giebel, MD Recruiting
Walla Walla, Washington, United States, 99362
Contact: Arthur W Giebel, MD     714-227-1258     art.giebel@flying.md    
Principal Investigator: Arthur W Giebel, 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:
Cornea Research Foundation of America website  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Cornea Research Foundation of America
ClinicalTrials.gov Identifier: NCT00800111     History of Changes
Other Study ID Numbers: CRFA2008-01
Study First Received: November 26, 2008
Last Updated: May 8, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013