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Study of Endothelial Keratoplasty Outcomes

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Cornea Research Foundation of America
Information provided by (Responsible Party):
Cornea Research Foundation of America Identifier:
First received: November 26, 2008
Last updated: January 30, 2017
Last verified: January 2017

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: No masking
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 Primary Completion Date: February 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00800111

Contact: Francis W Price, Jr., MD 317-814-2990

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

Additional Information:

Responsible Party: Cornea Research Foundation of America Identifier: NCT00800111     History of Changes
Other Study ID Numbers: CRFA2008-01
Study First Received: November 26, 2008
Last Updated: January 30, 2017

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

Additional relevant MeSH terms:
Iridocorneal Endothelial Syndrome
Fuchs' Endothelial Dystrophy
Corneal Diseases
Eye Diseases
Iris Diseases
Uveal Diseases
Corneal Dystrophies, Hereditary
Eye Diseases, Hereditary
Genetic Diseases, Inborn processed this record on May 25, 2017