Corneal Endothelium Delivery Instrument

Phase 2

• Conditions: Corneal Transplantation

• Registration Number: NCT00874835
• Lead Sponsor: Ocular Systems, Inc.

Brief 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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-01
• Study First Submitted QC: 2009-04-02
• Study First Posted: 2009-04-03
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-06
• Last Update Posted: 2010-05-07
• Primary Completion: 2010-10
• Study Completion: 2010-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with Fuchs endothelial dystrophy or bullous keratopathy determined to need a corneal transplant for visual restoration.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
6-month post-operative endothelial cell density	6-months post-operatively

Secondary Outcome Measures

Name	Time	Method
12-month post-operative endothelial cell density	12-months post-operatively

Trial Locations

Locations (1)

Wake Forest University Eye Center; 🇺🇸 Winston-Salem, North Carolina, United States