Status:
UNKNOWN
Corneal Endothelium Delivery Instrument
Lead Sponsor:
Ocular Systems, Inc.
Collaborating Sponsors:
Wake Forest University
Conditions:
Corneal Transplantation
Eligibility:
All Genders
45+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether the surgical outcomes in patients undergoing Descemet's Stripping Endothelial Keratoplasty (DSEK) are improved with the use of an insertion device ove...
Detailed Description
Laboratory studies and clinical functionality tests have shown that the study device safely forms the tissue without creasing or folding. It allows the allograft tissue to safely pass into the anterio...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients with Fuchs endothelial dystrophy or bullous keratopathy determined to need a corneal transplant for visual restoration.
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00874835
Start Date
March 1 2009
End Date
October 1 2010
Last Update
May 7 2010
Active Locations (1)
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1
Wake Forest University Eye Center
Winston-Salem, North Carolina, United States, 27157