Prospective Randomized Study Comparing Endothelial Cell Loss Using the Tan EndoGlide With Forceps… (NCT01284101) | Clinical Trial Compass
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Prospective Randomized Study Comparing Endothelial Cell Loss Using the Tan EndoGlide With Forceps for Insertion of the Donor Graft in DSAEK
Canada42 participantsStarted 2011-01
Plain-language summary
The Tan EndoGlide device results in less endothelial cell trauma during insertion of the donor corneal graft indicated by reduced endothelial cell loss at 1 year follow-up compared to the Forceps.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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