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Corneal Endothelium Delivery Instrument

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ClinicalTrials.gov Identifier: NCT00874835
Recruitment Status : Unknown
Verified May 2010 by Ocular Systems, Inc..
Recruitment status was:  Active, not recruiting
First Posted : April 3, 2009
Last Update Posted : May 7, 2010
Sponsor:
Collaborator:
Wake Forest University
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Corneal Transplantation Device: EndoSaver™ Corneal Endothelium Delivery Instrument Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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)
Study Start Date : March 2009
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : October 2010

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.


Primary Outcome Measures :
  1. 6-month post-operative endothelial cell density [ Time Frame: 6-months post-operatively ]

Secondary Outcome Measures :
  1. 12-month post-operative endothelial cell density [ Time Frame: 12-months post-operatively ]


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
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.

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

Responsible Party: Kurt R. Weber, Ocular Systems, Inc.
ClinicalTrials.gov Identifier: NCT00874835     History of Changes
Other Study ID Numbers: Endo33171
First Posted: April 3, 2009    Key Record Dates
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