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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01284101
First received: January 24, 2011
Last updated: January 25, 2011
Last verified: January 2011
History of Changes

January 24, 2011
January 25, 2011
January 2011
January 2012   (final data collection date for primary outcome measure)
  • Donor Graft Endothelial cell counts [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Best corrected visual acuity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01284101 on ClinicalTrials.gov Archive Site
Complications of surgery [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Prospective Randomized Study Comparing Endothelial Cell Loss Using the Tan EndoGlide With Forceps for Insertion of the Donor Graft in DSAEK
Prospective Randomized Study Comparing Endothelial Cell Loss Using the Tan EndoGlide With Forceps for Insertion of the Donor Graft in DSAEK

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Endothelial Cell Loss With Different Insertion Devices
  • Device: Use of the Tan Endoglide to insert the donor graft
    Using the Tan Endoglide to insert the donor graft into the eye
  • Device: Forceps for delivery of the donor graft
    Use of the forceps for delivery of the donor graft into the eye.
  • Active Comparator: Forceps delivery of donor graft
    Using the forceps to insert the donor graft.
    Intervention: Device: Forceps for delivery of the donor graft
  • Experimental: Tan Endoglide for insertion of the donor graft
    Use of the Tan Endoglide for insertion of the donor graft.
    Intervention: Device: Use of the Tan Endoglide to insert the donor graft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
Not Provided
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Allan R Slomovic, MA MD 416-603-5832 allan.slomovic@utoronto.ca
Canada
 
NCT01284101
REB-10-0632-B
Not Provided
Dr. Allan Slomovic, Toronto Western Hospital, University of Toronto
University Health Network, Toronto
Not Provided
Not Provided
University Health Network, Toronto
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP