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Study of Eye Bank Pre-cut Donor Grafts for Endothelial Keratoplasty

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ClinicalTrials.gov Identifier: NCT00624221
Recruitment Status : Completed
First Posted : February 27, 2008
Results First Posted : March 12, 2010
Last Update Posted : April 27, 2016
Sponsor:
Collaborators:
North Carolina Lion's Eye Bank
Price Vision Group
Information provided by:
Cornea Research Foundation of America

Tracking Information
First Submitted Date  ICMJE February 19, 2008
First Posted Date  ICMJE February 27, 2008
Results First Submitted Date  ICMJE February 2, 2010
Results First Posted Date  ICMJE March 12, 2010
Last Update Posted Date April 27, 2016
Study Start Date  ICMJE January 2006
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2010)
Endothelial Cell Loss [ Time Frame: 6 months after grafting ]
Endothelial cell density was measured by specular or confocal microscopy. Percent cell loss was calculated by subtracting the graft endothelial cell density measured at 6 months from the baseline donor endothelial cell density and dividing by the baseline donor endothelial cell density then multiplying by 100.
Original Primary Outcome Measures  ICMJE
 (submitted: February 19, 2008)
Endothelial Cell Loss [ Time Frame: 6 months after grafting ]
Change History Complete list of historical versions of study NCT00624221 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2008)
  • Best Corrected Vision [ Time Frame: 6 months and 1 year after grafting ]
  • Graft Dislocation [ Time Frame: 1 day to 1 month after grafting ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Eye Bank Pre-cut Donor Grafts for Endothelial Keratoplasty
Official Title  ICMJE A Prospective, Randomized, Single Center Study Evaluating Use of Surgeon- and Eye Bank-prepared Donor Tissue for Descemet's Stripping and Endothelial Keratoplasty, a Type of Cornea Transplant
Brief Summary Descemet's stripping with endothelial keratoplasty (DSEK) is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. The DSEK technique requires lamellar dissection of the donor tissue prior to implantation in the patient's eye. The surgeon usually dissects the donor cornea with a microkeratome at the time of surgery. Recently some eye banks have begun to pre-cut the donor graft as an added service. The purpose of this study was to compare outcomes with eye bank pre-cut and surgeon-dissected donor grafts for DSEK.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Fuchs Endothelial Dystrophy
  • Corneal Edema
Intervention  ICMJE Procedure: Descemet's stripping endothelial keratoplasty
Small incision corneal transplant procedure to treat dysfunctional endothelium.
Study Arms  ICMJE
  • Active Comparator: 1
    An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
    Intervention: Procedure: Descemet's stripping endothelial keratoplasty
  • Active Comparator: 2
    The surgeon dissected the donor grafts used for the transplant procedures.
    Intervention: Procedure: Descemet's stripping endothelial keratoplasty
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2008)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • candidate for Descemet's stripping with endothelial keratoplasty
  • at least 21 years old
  • willing and able to return for scheduled follow-up visits
  • reads and signs Informed Consent document

Exclusion Criteria:

  • visual acuity of less than 20/400 in fellow eye
  • known sensitivity to planned study concomitant medications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00624221
Other Study ID Numbers  ICMJE 2005-10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Francis W. Price, Jr. MD, Cornea Research Foundation of America
Study Sponsor  ICMJE Cornea Research Foundation of America
Collaborators  ICMJE
  • North Carolina Lion's Eye Bank
  • Price Vision Group
Investigators  ICMJE
Principal Investigator: Francis W Price, Jr, MD Cornea Research Foundation of America
PRS Account Cornea Research Foundation of America
Verification Date October 2010

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