Fuchs Endothelial DystrophyNCT00624221
Study of Eye Bank Pre-cut Donor Grafts for Endothelial Keratoplasty
A study testing Descemet's stripping endothelial keratoplasty in people with Fuchs Endothelial Dystrophy and Corneal Edema, run by Cornea Research Foundation of America at 1 site in United States.
Trial summary
Descemet's stripping with endothelial keratoplasty (DSEK) is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. The DSEK technique requires lamellar dissection of the donor tissue prior to implantation in the patient's eye. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Fuchs Endothelial Dystrophy, Corneal Edema
- What is being tested?
- Descemet's stripping endothelial keratoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Nov 2007
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- candidate for Descemet's stripping with endothelial keratoplasty
- at least 21 years old
- willing and able to return for scheduled follow-up visits
- reads and signs Informed Consent document
Who cannot join
- visual acuity of less than 20/400 in fellow eye
- known sensitivity to planned study concomitant medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Cornea Research Foundation of America
Indianapolis, Indiana, 46260
About this study
Official title: A Prospective, Randomized, Single Center Study Evaluating Use of Surgeon- and Eye Bank-prepared Donor Tissue for Descemet's Stripping and Endothelial Keratoplasty, a Type of Cornea Transplant
Descemet's stripping with endothelial keratoplasty (DSEK) is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. The DSEK technique requires lamellar dissection of the donor tissue prior to implantation in the patient's eye. The surgeon usually dissects the donor cornea with a microkeratome at the time of surgery. Recently some eye banks have begun to pre-cut the donor graft as an added service. The purpose of this study was to compare outcomes with eye bank pre-cut and surgeon-dissected donor grafts for DSEK.
- Conditions
- Fuchs Endothelial Dystrophy, Corneal Edema
- Being tested
- Descemet's stripping endothelial keratoplasty
- Medical subject headings
- Fuchs' Endothelial Dystrophy, Corneal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descemet's stripping endothelial keratoplastyProcedure or surgery
Small incision corneal transplant procedure to treat dysfunctional endothelium.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | An Eye bank pre-cut the donor grafts used for the corneal transplant procedures. Receives: Procedure: Descemet's stripping endothelial keratoplasty |
| 2 | Active comparator | The surgeon dissected the donor grafts used for the transplant procedures. Receives: Procedure: Descemet's stripping endothelial keratoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Cell Loss
Endothelial cell density was measured by specular or confocal microscopy. Percent cell loss was calculated by subtracting the graft endothelial cell density measured at 6 months from the baseline donor endothelial cell density and dividing by the baseline donor endothelial cell density then multiplying by 100.
Measured: 6 months after grafting
Secondary outcomes (2)
Best Corrected Vision
Measured: 6 months and 1 year after grafting
Graft Dislocation
Measured: 1 day to 1 month after grafting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startJan 2006
- Primary completionOct 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fuchs 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornea Research Foundation of America
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Lion's Eye Bank, Price Vision Group
- Investigators
- Francis W Price, Jr, MD, Principal investigator, Cornea Research Foundation of America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624221
- Sponsor's protocol ID
- 2005-10
- Status last verified
- Oct 2010
- First submitted
- 19 Feb 2008
- Last updated
- 27 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single Center Study Evaluating Use of Surgeon- and Eye Bank-prepared Donor Tissue for Descemet's Stripping and Endothelial Keratoplasty, a Type of Cornea Transplant
- ClinicalTrials.gov ID
- NCT00624221
- Acronym / sponsor ID
- 2005-10
- Conditions
- Fuchs Endothelial Dystrophy, Corneal Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cornea Research Foundation of AmericaUniversity, hospital or other
- Collaborators
- North Carolina Lion's Eye Bank, Price Vision Group
- Study start
- Jan 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 27 Feb 2008 (estimated)
- Results
- Posted 12 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Descemet's stripping with endothelial keratoplasty (DSEK) is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. The DSEK technique requires lamellar dissection of the donor tissue prior to implantation in the patient's eye. The surgeon usually dissects the donor cornea with a microkeratome at the time of surgery. Recently some eye banks have begun to pre-cut the donor graft as an added service. The purpose of this study was to compare outcomes with eye bank pre-cut and surgeon-dissected donor grafts for DSEK.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Descemet's stripping endothelial keratoplastyAn Eye bank pre-cut the donor grafts used for the corneal transplant procedures. |
| 2 | Active comparator | Procedure: Descemet's stripping endothelial keratoplastyThe surgeon dissected the donor grafts used for the transplant procedures. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- candidate for Descemet's stripping with endothelial keratoplasty
- at least 21 years old
- willing and able to return for scheduled follow-up visits
- reads and signs Informed Consent document
Key exclusion criteria (2 listed)
- visual acuity of less than 20/400 in fellow eye
- known sensitivity to planned study concomitant medications
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 |
|---|---|---|
| Descemet's stripping endothelial keratoplastySmall incision corneal transplant procedure to treat dysfunctional endothelium. | Procedure or surgery | 1, 2 |
Primary outcome
Endothelial Cell Loss
Time frame: 6 months after grafting
Endothelial cell density was measured by specular or confocal microscopy. Percent cell loss was calculated by subtracting the graft endothelial cell density measured at 6 months from the baseline donor endothelial cell density and dividing by the baseline donor endothelial cell density then multiplying by 100.
2 secondary outcomes
Best Corrected Vision
Time frame: 6 months and 1 year after grafting
Graft Dislocation
Time frame: 1 day to 1 month after grafting
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Fuchs 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.
Francis W Price, Jr, MD principal investigator
Cornea Research Foundation of America
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Descemet's stripping endothelial keratoplasty in people with Fuchs Endothelial Dystrophy and Corneal Edema, run by Cornea Research Foundation of America 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 27 Apr 2016. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Endothelial Cell Loss (time frame: 6 months after grafting). 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 27 Apr 2016.