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Corneal Endothelium Delivery Instrument

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Ocular Systems, Inc..
Recruitment status was:  Active, not recruiting
Wake Forest University
Information provided by:
Ocular Systems, Inc. Identifier:
First received: April 1, 2009
Last updated: May 6, 2010
Last verified: May 2010
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.

Condition Intervention Phase
Corneal Transplantation
Device: EndoSaver™ Corneal Endothelium Delivery Instrument
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endothelial Graft Injector Versus Folding Forceps Insertion During Descemet's Stripping Endothelial Keratoplasty (DSEK)

Further study details as provided by Ocular Systems, Inc.:

Primary Outcome Measures:
  • 6-month post-operative endothelial cell density [ Time Frame: 6-months post-operatively ]

Secondary Outcome Measures:
  • 12-month post-operative endothelial cell density [ Time Frame: 12-months post-operatively ]

Estimated Enrollment: 100
Study Start Date: March 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with Fuchs endothelial dystrophy or bullous keratopathy determined to need a corneal transplant for visual restoration.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00874835

United States, North Carolina
Wake Forest University Eye Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Ocular Systems, Inc.
Wake Forest University
Principal Investigator: Keith A Walter, MD Wake Forest University Eye Center
  More Information

Responsible Party: Kurt R. Weber, Ocular Systems, Inc. Identifier: NCT00874835     History of Changes
Other Study ID Numbers: Endo33171
Study First Received: April 1, 2009
Last Updated: May 6, 2010

Keywords provided by Ocular Systems, Inc.:
Endothelial Keratoplasty
Descemet Stripping Endothelial Keratoplasty
Corneal Transplantation
DSAEK processed this record on May 25, 2017