Corneal Endothelium Delivery Instrument
Recruitment status was: Active, not recruiting
|Corneal Transplantation||Device: EndoSaver™ Corneal Endothelium Delivery Instrument||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Endothelial Graft Injector Versus Folding Forceps Insertion During Descemet's Stripping Endothelial Keratoplasty (DSEK)|
- 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 ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||October 2010|
|Estimated Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Device: EndoSaver™ Corneal Endothelium Delivery Instrument
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|