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Study of Endothelial Keratoplasty Outcomes

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ClinicalTrials.gov Identifier: NCT00800111
Recruitment Status : Completed
First Posted : December 1, 2008
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Cornea Research Foundation of America

Study Description
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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
Fuchs' Endothelial Corneal Dystrophy Bullous Keratopathy Iridocorneal Endothelial Syndrome Posterior Polymorphous Dystrophy Procedure: endothelial keratoplasty Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2593 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-enrollment, Prospective Study of Endothelial Keratoplasty Outcomes
Study Start Date : February 2008
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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


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

Publications of Results:

Other Publications:

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Responsible Party: Cornea Research Foundation of America
ClinicalTrials.gov Identifier: NCT00800111    
Other Study ID Numbers: CRFA2008-01
First Posted: December 1, 2008    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Keywords provided by Cornea Research Foundation of America:
failed penetrating keratoplasty
Additional relevant MeSH terms:
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Iridocorneal Endothelial Syndrome
Fuchs' Endothelial Dystrophy
Corneal Diseases
Eye Diseases
Iris Diseases
 Uveal Diseases
Corneal Dystrophies, Hereditary
Eye Diseases, Hereditary
Genetic Diseases, Inborn