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

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 2011 by Legacy Health System.
Recruitment status was:  Active, not recruiting
Legacy Devers Eye Institute
Lions Eye Bank of Oregon Vision Research Laboratory
Fischer Surgical, Inc.
Information provided by:
Legacy Health System Identifier:
First received: May 16, 2011
Last updated: May 19, 2011
Last verified: May 2011
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
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)

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 ]
    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) ]
    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.


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

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 identifier: NCT01357122

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.
Principal Investigator: Mark A Terry, MD Legacy Devers Eye Institute
  More Information

Responsible Party: Mark A. Terry, MD/Director of Corneal Services, Deverse Eye Institute Identifier: NCT01357122     History of Changes
Other Study ID Numbers: LEBO-2009-1
Study First Received: May 16, 2011
Last Updated: May 19, 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 processed this record on September 19, 2017