Status:
UNKNOWN
Comparing Endoglide to Endoserter for DSAEK Graft Insertion
Lead Sponsor:
University Health Network, Toronto
Conditions:
Fuch's Endothelial Dystrophy
Bullous Keratopathy, Unspecified Eye
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the Tan EndoGlide with the new Endoserter injector in terms of damage to the donor corneal endothelium by comparing the endothelial cell loss at 1 month, 3 mont...
Detailed Description
Descemet's stripping automated endothelial keratoplasty (DSAEK) is a widely performed method of corneal transplantation. It is now considered the standard of care for the treatment of endothelial cell...
Eligibility Criteria
Inclusion
- Patients presenting with corneal decompensation requiring DSAEK with or without cataract surgery for visual rehabilitation.
- Clinical diagnosis include endothelial cell dysfunction secondary to Fuchs endothelial dystrophy, pseudophakic or aphakic bullous keratopathy, failed penetrating keratoplasty or DSAEK, iridocorneal endothelial syndrome or trauma.
- Ability to understand the nature of the procedure and give full informed consent.
- Patients who are able to comply with the standard DSAEK follow-up protocol at the Toronto Western Hospital.
Exclusion
- Patients with late stage corneal decompensation with stromal scarring unsuitable for DSAEK and therefore requiring penetrating keratoplasty.
- Patients with complex anterior segment pathology precluding successful DSAEK procedure.
- Patients not giving full informed consent to participate in the trial
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2014
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01791075
Start Date
January 1 2012
End Date
January 1 2014
Last Update
February 15 2013
Active Locations (1)
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1
Toronto Western Hospital
Toronto, Ontario, Canada