Corneal Endothelium Delivery Instrument

Corneal Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00874835
• Other study ID #: Endo33171
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 1, 2009
• Last updated: May 6, 2010
• Start date: March 2009
• Est. completion date: October 2010

Study information

• Verified date: May 2010
• Source: Ocular Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

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

Study Design

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

Related Conditions & MeSH terms

• Corneal Transplantation

Intervention

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.

Locations

Country	Name	City	State
United States	Wake Forest University Eye Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Ocular Systems, Inc.	Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-month post-operative endothelial cell density		6-months post-operatively	No
Secondary	12-month post-operative endothelial cell density		12-months post-operatively	No