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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Fuchs Endothelial Dystrophy
Corneal Edema
Intervention: Procedure: Descemet's stripping endothelial keratoplasty

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Eye Bank Pre-cut Grafts An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
Surgeon Dissected Grafts The surgeon dissected the donor grafts used for the transplant procedures.

Participant Flow:   Overall Study
    Eye Bank Pre-cut Grafts   Surgeon Dissected Grafts
STARTED   20   20 
COMPLETED   20   20 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Eye Bank Pre-cut Grafts An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
Surgeon Dissected Grafts The surgeon dissected the donor grafts used for the transplant procedures.
Total Total of all reporting groups

Baseline Measures
   Eye Bank Pre-cut Grafts   Surgeon Dissected Grafts   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   40 
Age 
[Units: Years]
Mean (Standard Deviation)
 70  (12)   72  (13)   71  (12) 
Gender 
[Units: Participants]
     
Female   12   13   25 
Male   8   7   15 
Region of Enrollment 
[Units: Participants]
     
United States   20   20   40 


  Outcome Measures

1.  Primary:   Endothelial Cell Loss   [ Time Frame: 6 months after grafting ]

2.  Secondary:   Best Corrected Vision   [ Time Frame: 6 months and 1 year after grafting ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Graft Dislocation   [ Time Frame: 1 day to 1 month after grafting ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Marianne O. Price, PhD
Organization: Cornea Research Foundation of America
phone: 317-814-2990
e-mail: mprice@cornea.org



Responsible Party: Francis W. Price, Jr. MD, Cornea Research Foundation of America
ClinicalTrials.gov Identifier: NCT00624221     History of Changes
Other Study ID Numbers: 2005-10
First Submitted: February 19, 2008
First Posted: February 27, 2008
Results First Submitted: February 2, 2010
Results First Posted: March 12, 2010
Last Update Posted: April 27, 2016