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Clinical Trials/NCT00800111
NCT00800111
Completed
Not Applicable

Open-enrollment, Prospective Study of Endothelial Keratoplasty Outcomes

Cornea Research Foundation of America1 site in 1 country2,593 target enrollmentFebruary 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fuchs' Endothelial Corneal Dystrophy
Sponsor
Cornea Research Foundation of America
Enrollment
2593
Locations
1
Primary Endpoint
Visual acuity
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2008
End Date
February 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Visual acuity

Time Frame: 1, 3, 6, and 12 months and annually

Secondary Outcomes

  • Endothelial cell density(6 months, 12 months and annually)
  • Intraocular pressure(1, 3, 6, 12 months and annually)
  • Manifest refraction(1, 3, 6, 12 months and annually)
  • corneal pachymetry(1, 3, 6, 12 months and annually)

Study Sites (1)

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