Corneal Endothelium Delivery Instrument

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Ocular Systems, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Wake Forest School of Medicine
Information provided by:
Ocular Systems, Inc.
ClinicalTrials.gov Identifier:
NCT00874835
First received: April 1, 2009
Last updated: May 6, 2010
Last verified: May 2010
  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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 12-month post-operative endothelial cell density [ Time Frame: 12-months post-operatively ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 School of Medicine
Investigators
Principal Investigator: Keith A Walter, MD Wake Forest University Eye Center
  More Information

No publications provided

Responsible Party: Kurt R. Weber, Ocular Systems, Inc.
ClinicalTrials.gov Identifier: NCT00874835     History of Changes
Other Study ID Numbers: Endo33171
Study First Received: April 1, 2009
Last Updated: May 6, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 22, 2014