Corneal Endothelium Delivery Instrument

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Corneal Transplantation

Clinical Trial Details

NCT number	NCT00874835
Study type	Interventional
Source	Ocular Systems, Inc.
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	March 2009
Completion date	October 2010

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See also
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