Corneal Endothelium Delivery Instrument

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Ocular Systems, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Wake Forest School of Medicine
Information provided by:
Ocular Systems, Inc.
ClinicalTrials.gov Identifier:
NCT00874835
First received: April 1, 2009
Last updated: May 6, 2010
Last verified: May 2010

April 1, 2009
May 6, 2010
March 2009
October 2010   (final data collection date for primary outcome measure)
6-month post-operative endothelial cell density [ Time Frame: 6-months post-operatively ] [ Designated as safety issue: No ]
Post operative endothelial cell density [ Time Frame: 3-month and 6-month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00874835 on ClinicalTrials.gov Archive Site
12-month post-operative endothelial cell density [ Time Frame: 12-months post-operatively ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Corneal Endothelium Delivery Instrument
Endothelial Graft Injector Versus Folding Forceps Insertion During Descemet's Stripping Endothelial Keratoplasty (DSEK)

The purpose of this study is to determine whether the surgical outcomes in patients undergoing Descemet's Stripping Endothelial Keratoplasty (DSEK) are improved with the use of an insertion device over the traditional forceps insertion method.

Laboratory studies and clinical functionality tests have shown that the study device safely forms the tissue without creasing or folding. It allows the allograft tissue to safely pass into the anterior chamber without compression, crushing, or squeezing the endothelial cells.

The device provides continuous irrigation into the eye to prevent collapse of the anterior chamber during insertion. Our study will focus on the safety and efficacy of the novel instrument over the current method of insertion (forceps).

FDA has classified the device as Class I, Reserved.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Corneal Transplantation
Device: EndoSaver™ Corneal Endothelium Delivery Instrument
Efficacy of device to maintain function and integrity of corneal endothelial cells during insertion into the eye during keratoplasty.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with Fuchs endothelial dystrophy or bullous keratopathy determined to need a corneal transplant for visual restoration.
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00874835
Endo33171
Yes
Kurt R. Weber, Ocular Systems, Inc.
Ocular Systems, Inc.
Wake Forest School of Medicine
Principal Investigator: Keith A Walter, MD Wake Forest University Eye Center
Ocular Systems, Inc.
May 2010

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