NCT00874835

Corneal Endothelium Delivery Instrument

Endothelial Graft Injector Versus Folding Forceps Insertion During Descemet's Stripping Endothelial Keratoplasty (DSEK)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ocular Systems, Inc. · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Corneal Transplantation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2009-04-03
• Last updated: 2010-05-07

Locations

1 site across 1 country: United States