Corneal Endothelium Delivery Instrument

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00874835
Recruitment Status : Unknown
Verified May 2010 by Ocular Systems, Inc..
Recruitment status was:  Active, not recruiting
First Posted : April 3, 2009
Last Update Posted : May 7, 2010
Wake Forest University
Information provided by:
Ocular Systems, Inc.

April 1, 2009
April 3, 2009
May 7, 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 ]
Post operative endothelial cell density [ Time Frame: 3-month and 6-month ]
Complete list of historical versions of study NCT00874835 on Archive Site
12-month post-operative endothelial cell density [ Time Frame: 12-months post-operatively ]
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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.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (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.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
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.
Sexes Eligible for Study: All
45 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Kurt R. Weber, Ocular Systems, Inc.
Ocular Systems, Inc.
Wake Forest University
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