Fuchs' Corneal Endothelial DystrophyPhase 4NCT01357122
Evaluating Results of Neusidl Corneal Inserter in Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)
A Phase 4 study testing NCI Insertion and Standard Forceps Insertion in people with Fuchs' Corneal Endothelial Dystrophy, run by Legacy Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Fuchs' Corneal Endothelial Dystrophy
- What is being tested?
- NCI Insertion and Standard Forceps Insertion
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Nov 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 and over
- A diagnosis of Fuchs' Corneal Endothelial Dystrophy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Fuchs' Corneal Endothelial Dystrophy
- Being tested
- NCI Insertion, Standard Forceps Insertion
- Medical subject headings
- Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCI InsertionDevice
DSAEK surgery will be performed using the NCI to insert the donor tissue.
Standard Forceps InsertionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| NCI Insertion | Experimental | Not described Receives: Device: NCI Insertion |
| Standard Forceps Insertion | Active comparator | Not described Receives: Procedure: Standard Forceps Insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6, 12, 24, and 60 Months
Secondary outcomes (1)
Adverse events
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.
Measured: Any time during follow-up period (5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startJul 2009
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fuchs' Corneal Endothelial DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Legacy Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Devers Eye Institute, Lions Eye Bank of Oregon Vision Research Laboratory, Fischer Surgical, Inc.
- Investigators
- Mark A Terry, MD, Principal investigator, Devers Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357122
- Sponsor's protocol ID
- LEBO-2009-1
- Status last verified
- May 2011
- First submitted
- 16 May 2011
- Last updated
- 20 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01357122
- Acronym / sponsor ID
- LEBO-2009-1
- Conditions
- Fuchs' Corneal Endothelial Dystrophy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Legacy Health SystemUniversity, hospital or other
- Collaborators
- Devers Eye Institute, Lions Eye Bank of Oregon Vision Research Laboratory, Fischer Surgical, Inc.
- Study start
- Jul 2009
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 20 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NCI Insertion | Experimental | Device: NCI Insertion |
| Standard Forceps Insertion | Active comparator | Procedure: Standard Forceps Insertion |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 21 and over
- A diagnosis of Fuchs' Corneal Endothelial Dystrophy
Key exclusion criteria (8 listed)
- Under age 21
- Diagnosis of advanced glaucomatous disease
- Diagnosis of significant retinal disease
- Diagnosis of any other corneal dystrophy
- Previous corneal transplant surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NCI InsertionDSAEK surgery will be performed using the NCI to insert the donor tissue. | Device | NCI Insertion |
| Standard Forceps InsertionDSAEK surgery will be performed using forceps to insert the donor tissue. This is our long-established technique for DSAEK, with well-documented excellent results. | Procedure or surgery | Standard Forceps Insertion |
Primary outcome
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.
1 secondary outcome
Adverse events
Time frame: Any time during follow-up period (5 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2011.
Related trials for Fuchs' Corneal Endothelial Dystrophy
Active, not recruitingPhase 3
Descemet Endothelial Thickness Comparison Trial II
Fuchs, Fuchs Dystrophy
RecruitingPhase 2
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Fuchs
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
RecruitingPhase 2
DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Fuchs
Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
Corneal Edema, Corneal Endothelial Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A Terry, MD principal investigator
Devers Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NCI Insertion and Standard Forceps Insertion in people with Fuchs' Corneal Endothelial Dystrophy, run by Legacy Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in Endothelial Cell Density From Baseline Over Time (time frame: 6, 12, 24, and 60 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2011.