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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Devers Eye Institute
Lions Eye Bank of Oregon Vision Research Laboratory
Fischer Surgical, Inc.
Information provided by:
Legacy Health System
ClinicalTrials.gov Identifier:
NCT01357122
First received: May 16, 2011
Last updated: May 19, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Fuchs' Corneal Endothelial Dystrophy
Device: NCI Insertion
Procedure: Standard Forceps Insertion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Legacy Health System:

Primary Outcome Measures:
  • Decrease in Endothelial Cell Density From Baseline Over Time [ Time Frame: 6, 12, 24, and 60 Months ] [ Designated as safety issue: No ]
    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:
  • Adverse events [ Time Frame: Any time during follow-up period (5 years) ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 100
Study Start Date: July 2009
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
  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: NCT01357122

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

No publications provided

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
Study First Received: May 16, 2011
Last Updated: May 19, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Iridocorneal Endothelial Syndrome
Corneal Diseases
Eye Diseases
Iris Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on October 02, 2014