Fuch's Endothelial DystrophyNCT01610973
Comparison of Two Techniques in Achieving Corneal Graft
A study testing Endothelial descemet membrane graft in people with Fuch's Endothelial Dystrophy, run by University Hospital, Rouen at 1 site in France.
Trial summary
The cornea is a transparent membrane, half a millimeter thick, embedded as a window in front of the eye. When the eye becomes opaque, the eye is not seeing and the only way to restore the visual acuity is to replace the cornea by performing a graft (4000 surgeries per year in France). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fuch's Endothelial Dystrophy
- What is being tested?
- Endothelial descemet membrane graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Aug 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and woman
- 18 years old or more
- Patient having been informed about the study and having signed a non-opposition to the participation
Who cannot join
- Patient presenting an associated eye pathology previously known and able to limit the visual recovery (age-related macular degeneration, diabetic retinopathy, ...)
- Pregnant women, parturient or breast feeding
- refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Manual and Automated Techniques in Achieving Posterior Lamellar Transplantation of the Cornea
The cornea is a transparent membrane, half a millimeter thick, embedded as a window in front of the eye.
When the eye becomes opaque, the eye is not seeing and the only way to restore the visual acuity is to replace the cornea by performing a graft (4000 surgeries per year in France). In half the cases the opacification of the cornea is secondary to dysfunction of the endothelium, cell layer of 15 μm thickness, covering its posterior surface, in charge of regulating the moisture of the corneal thickness and therefore its transparency.
Read more
While the total corneal transplantation has long been the only intervention for these diseases, it is now possible, from 4-5 years, to replace only the very thin: it is called endothelial transplant or graft lamellar later. This intervention is now experiencing significant success as it reduces very significantly the incidence of complications found after transplantation of total cornea and the visual recovery period. This type of transplant is still difficult to achieve and the best technique is not yet established.
Indeed, posterior lamellar transplantation of the cornea may be done manually or using an automated device. Manual techniques allow the preparation of grafts extremely thin but are difficult to achieve while the automatic techniques, easier, prepare thicker grafts that may be less efficient in visual recovery.
The aim of this project is to conduct a prospective study in order to compare these two techniques in terms of postoperative visual recovery and the vitality of the graft during the first year. To date, there is no such study.
The department of Ophthalmology in the University Hospital of Rouen is one of the most famous French teams in the field of cornea transplants and receives many patients from different French regions. The recruitment of 40 patients needed to study should be done without great difficulty over a period of 18 months.
- Conditions
- Fuch's Endothelial Dystrophy
- Being tested
- Endothelial descemet membrane graft
- Keywords
- Fuch's dystrophy, Corneal graft
- 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.
Endothelial descemet membrane graftProcedure or surgery
Standard Endothelial descemet membrane graft
Endothelial descemet membrane graftProcedure or surgery
Standard Endothelial descemet membrane graft
| Study group | Role | What they receive |
|---|---|---|
| Manual preparation | Experimental | Manual preparation of the graft Receives: Procedure: Endothelial descemet membrane graft |
| Automatized preparation | Active comparator | Automatized preparation of the graft with microkeratoma Receives: Procedure: Endothelial descemet membrane graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of visual acuity
Measured: 1 year
Secondary outcomes (5)
Occular hypertension
Measurement of occular hypertension
Measured: Day 7, Day 15, Month 1, Month 2, Month 6, 1 year
Measurement of visual acuity
Measured: Month 1, Month 2, Month 6
Partial or complete graft detachment
% of detachment
Measured: Day 7, Day 15, Month 1, Month 2, Month 6, 1 year
Necessity of air injection
Necessity of air injection : yes/no
Measured: Day 7, Day 15, Month 1, Month 2, Month 6, 1 year
Defeat of the graft
Defeat of the graft : yes/no
Measured: Day 7, Day 15, Month 1, Month 2, Month 6, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fuch's Endothelial DystrophyStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc MURAINE, Pr, Principal investigator, UH Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610973
- Sponsor's protocol ID
- 2010/084/HP
- Other IDs
- 2011-A00221-40
- Status last verified
- Oct 2016
- First submitted
- 25 Apr 2012
- Last updated
- 10 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Manual and Automated Techniques in Achieving Posterior Lamellar Transplantation of the Cornea
- ClinicalTrials.gov ID
- NCT01610973
- Acronym / sponsor ID
- 2010/084/HP
- Conditions
- Fuch's Endothelial Dystrophy
- Keywords
- Fuch's dystrophy, Corneal graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 4 Jun 2012 (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.
The cornea is a transparent membrane, half a millimeter thick, embedded as a window in front of the eye.
When the eye becomes opaque, the eye is not seeing and the only way to restore the visual acuity is to replace the cornea by performing a graft (4000 surgeries per year in France). In half the cases the opacification of the cornea is secondary to dysfunction of the endothelium, cell layer of 15 μm thickness, covering its posterior surface, in charge of regulating the moisture of the corneal thickness and therefore its transparency.
While the total corneal transplantation has long been the only intervention for these diseases, it is now possible, from 4-5 years, to replace only the very thin: it is called endothelial transplant or graft lamellar later. This intervention is now experiencing significant success as it reduces very significantly the incidence of complications found after transplantation of total cornea and the visual recovery period. This type of transplant is still difficult to achieve and the best technique is not yet established.
Indeed, posterior lamellar transplantation of the cornea may be done manually or using an automated device. Manual techniques allow the preparation of grafts extremely thin but are difficult to achieve while the automatic techniques, easier, prepare thicker grafts that may be less efficient in visual recovery.
The aim of this project is to conduct a prospective study in order to compare these two techniques in terms of postoperative visual recovery and the vitality of the graft during the first year. To date, there is no such study.
The department of Ophthalmology in the University Hospital of Rouen is one of the most famous French teams in the field of cornea transplants and receives many patients from different French regions. The recruitment of 40 patients needed to study should be done without great difficulty over a period of 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual preparation | Experimental | Procedure: Endothelial descemet membrane graftManual preparation of the graft |
| Automatized preparation | Active comparator | Procedure: Endothelial descemet membrane graftAutomatized preparation of the graft with microkeratoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men and woman
- 18 years old or more
- Patient having been informed about the study and having signed a non-opposition to the participation
Key exclusion criteria (3 listed)
- Patient presenting an associated eye pathology previously known and able to limit the visual recovery (age-related macular degeneration, diabetic retinopathy, ...)
- Pregnant women, parturient or breast feeding
- refusal to participate in the study
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 |
|---|---|---|
| Endothelial descemet membrane graftStandard Endothelial descemet membrane graft | Procedure or surgery | Manual preparation |
| Endothelial descemet membrane graftStandard Endothelial descemet membrane graft | Procedure or surgery | Automatized preparation |
Primary outcome
Measurement of visual acuity
Time frame: 1 year
5 secondary outcomes
Occular hypertension
Time frame: Day 7, Day 15, Month 1, Month 2, Month 6, 1 year
Measurement of visual acuity
Time frame: Month 1, Month 2, Month 6
Partial or complete graft detachment
Time frame: Day 7, Day 15, Month 1, Month 2, Month 6, 1 year
Necessity of air injection
Time frame: Day 7, Day 15, Month 1, Month 2, Month 6, 1 year
Defeat of the graft
Time frame: Day 7, Day 15, Month 1, Month 2, Month 6, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2016.
Related trials for Fuch's Endothelial Dystrophy
Active, not recruitingPhase 3
Descemet Endothelial Thickness Comparison Trial II
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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
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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.
Marc MURAINE, Pr principal investigator
UH Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endothelial descemet membrane graft in people with Fuch's Endothelial Dystrophy, run by University Hospital, Rouen at 1 site in France.
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 3 inclusion and 3 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 10 Oct 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measurement of visual acuity (time frame: 1 year). 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 10 Oct 2016.