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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Efficacy of device to maintain function and integrity of corneal endothelial cells during insertion into the eye during keratoplasty.
Wake Forest University Eye Center
Winston-Salem, North Carolina, United States
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
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