Corneal Endothelium Delivery Instrument

Overview

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.

Full Title of Study: “Endothelial Graft Injector Versus Folding Forceps Insertion During Descemet’s Stripping Endothelial Keratoplasty (DSEK)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2010

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.

Interventions

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 6-month post-operative endothelial cell density
    • Time Frame: 6-months post-operatively

Secondary Measures

  • 12-month post-operative endothelial cell density
    • Time Frame: 12-months post-operatively

Participating in This Clinical Trial

Inclusion Criteria

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

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ocular Systems, Inc.
  • Collaborator
    • Wake Forest University
  • Provider of Information About this Clinical Study
    • Kurt R. Weber, Ocular Systems, Inc.
  • Overall Official(s)
    • Keith A Walter, MD, Principal Investigator, Wake Forest University Eye Center

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