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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00874835
First Posted: April 3, 2009
Last Update Posted: May 7, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Wake Forest University
Information provided by:
Ocular Systems, Inc.
  Purpose
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: None (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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Patients with Fuchs endothelial dystrophy or bullous keratopathy determined to need a corneal transplant for visual restoration.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874835


Locations
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
Investigators
Principal Investigator: Keith A Walter, MD Wake Forest University Eye Center
  More Information

Responsible Party: Kurt R. Weber, Ocular Systems, Inc.
ClinicalTrials.gov Identifier: NCT00874835     History of Changes
Other Study ID Numbers: Endo33171
First Submitted: April 1, 2009
First Posted: April 3, 2009
Last Update Posted: May 7, 2010
Last Verified: May 2010

Keywords provided by Ocular Systems, Inc.:
Endothelial Keratoplasty
EK
Descemet Stripping Endothelial Keratoplasty
Corneal Transplantation
Keratoplasty
DSEK
DSAEK