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Evaluating Results of Neusidl Corneal Inserter in Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)

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ClinicalTrials.gov Identifier: NCT01357122
Recruitment Status : Unknown
Verified May 2011 by Legacy Health System.
Recruitment status was:  Active, not recruiting
First Posted : May 20, 2011
Last Update Posted : May 20, 2011
Sponsor:
Collaborators:
Legacy Devers Eye Institute
Lions Eye Bank of Oregon Vision Research Laboratory
Fischer Surgical, Inc.
Information provided by:
Legacy Health System

Brief Summary:
This project compares the Neusidl Corneal Injector (NCI) device developed by Fischer Surgical, Inc. for the delivery of tissue into the eye in DSAEK surgery to the current standard forceps insertion DSAEK technique. The goal of this study is to examine the damage to the corneal endothelium resulting from the use of the NCI device in comparison to the use of our standard surgical DSAEK technique over time.

Condition or disease Intervention/treatment Phase
Fuchs' Corneal Endothelial Dystrophy Device: NCI Insertion Procedure: Standard Forceps Insertion Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Observer-masked, Clinical Trial Comparing the Neusidl Corneal Inserter Corneal Transplant Technique to the Standard Forceps Insertion Technique for Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)
Study Start Date : July 2009
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2015


Arm Intervention/treatment
Experimental: NCI Insertion Device: NCI Insertion
DSAEK surgery will be performed using the NCI to insert the donor tissue.
Active Comparator: Standard Forceps Insertion Procedure: Standard Forceps Insertion
DSAEK surgery will be performed using forceps to insert the donor tissue. This is our long-established technique for DSAEK, with well-documented excellent results.



Primary Outcome Measures :
  1. Decrease in Endothelial Cell Density From Baseline Over Time [ Time Frame: 6, 12, 24, and 60 Months ]
    Endothelial cell density (ECD) will be captured at each follow-up visit using a non-contact specular microscope. % Cell reduction from pre-operative baseline ECD will be calculated for each patient, and compared between treatment arms to evaluate each instrument's effect on long-term post-operative endothelial cell density.


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Any time during follow-up period (5 years) ]
    Each patient will be monitored for incidence of graft dislocation, primary graft failure, immunologic graft rejection, and late endothelial failure. Rates will be compared between groups to ensure that the NCI does not increase the risk of these adverse events.



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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 21 and over
  • A diagnosis of Fuchs' Corneal Endothelial Dystrophy

Exclusion Criteria:

  • Under age 21
  • Diagnosis of advanced glaucomatous disease
  • Diagnosis of significant retinal disease
  • Diagnosis of any other corneal dystrophy
  • Previous corneal transplant surgery
  • Previous glaucoma surgery
  • Previous retinal surgery
  • Previous refractive surgery

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): NCT01357122


Locations
United States, Oregon
Devers Eye Institute
Portland, Oregon, United States, 97266
Sponsors and Collaborators
Legacy Health System
Legacy Devers Eye Institute
Lions Eye Bank of Oregon Vision Research Laboratory
Fischer Surgical, Inc.
Investigators
Principal Investigator: Mark A Terry, MD Legacy Devers Eye Institute

Responsible Party: Mark A. Terry, MD/Director of Corneal Services, Deverse Eye Institute
ClinicalTrials.gov Identifier: NCT01357122     History of Changes
Other Study ID Numbers: LEBO-2009-1
First Posted: May 20, 2011    Key Record Dates
Last Update Posted: May 20, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Iridocorneal Endothelial Syndrome
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Iris Diseases
Uveal Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn