Corneal Endothelium Delivery Instrument
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Corneal Transplantation||Device: EndoSaver™ Corneal Endothelium Delivery Instrument||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endothelial Graft Injector Versus Folding Forceps Insertion During Descemet's Stripping Endothelial Keratoplasty (DSEK)|
|Study Start Date :||March 2009|
|Estimated Primary Completion Date :||October 2010|
|Estimated Study Completion Date :||October 2010|
Device: EndoSaver™ Corneal Endothelium Delivery Instrument
- 6-month post-operative endothelial cell density [ Time Frame: 6-months post-operatively ]
- 12-month post-operative endothelial cell density [ Time Frame: 12-months post-operatively ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874835
|United States, North Carolina|
|Wake Forest University Eye Center|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Keith A Walter, MD||Wake Forest University Eye Center|