Evaluating Results of Neusidl Corneal Inserter in Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)
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)
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2009
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 16, 2011
CompletedFirst Posted
Study publicly available on registry
May 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedMay 20, 2011
May 1, 2011
6.3 years
May 16, 2011
May 19, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Decrease in Endothelial Cell Density From Baseline Over Time
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.
6, 12, 24, and 60 Months
Secondary Outcomes (1)
Adverse events
Any time during follow-up period (5 years)
Study Arms (2)
NCI Insertion
EXPERIMENTALStandard Forceps Insertion
ACTIVE COMPARATORInterventions
DSAEK surgery will be performed using the NCI to insert the donor tissue.
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 Criteria
You may qualify if:
- Age 21 and over
- A diagnosis of Fuchs' Corneal Endothelial Dystrophy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Legacy Health Systemlead
- Devers Eye Institutecollaborator
- Lions Eye Bank of Oregon Vision Research Laboratorycollaborator
- Fischer Surgical, Inc.collaborator
Study Sites (1)
Devers Eye Institute
Portland, Oregon, 97266, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark A Terry, MD
Devers Eye Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 16, 2011
First Posted
May 20, 2011
Study Start
July 1, 2009
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
May 20, 2011
Record last verified: 2011-05