KeratoconusBELIEvENCT02849808
Long Term Cornea Graft Survival Study
An observational study of Keratoconus and Fuchs' Endothelial Dystrophy, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Corneal transplantation have been performed for several decades, follow-up time in some centers now exceeds 30 years. Published long term (10 years and up) graft survivals vary considerably from center to center. These variations may be explained by differences in case-mix and surgical techniques used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus, Fuchs' Endothelial Dystrophy
- How many people
- 564 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2015to 3 Aug 2017
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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
Study population: All patients who underwent one or more keratoplasties since january 1983 at the University Hospital of Besançon
Who may be able to join
- All patients who underwent one or more keratoplasties since january 1983.
- Age 18 and older
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Cornea Graft Survival Study (Étude Bisontine d'Estimation de la Survie à Long Terme à Partir Des données de Suivi Internes au CHRU : Evaluation Epidémiologie Clinique)
Corneal transplantation have been performed for several decades, follow-up time in some centers now exceeds 30 years. Published long term (10 years and up) graft survivals vary considerably from center to center. These variations may be explained by differences in case-mix and surgical techniques used.
The investigators aim to better understand the factors associated with long term graft survival.
- Conditions
- Keratoconus, Fuchs' Endothelial Dystrophy
- Keywords
- Corneal Transplantation
- Medical subject headings
- Keratoconus, Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Keratoplasty patients | All patients who underwent one or more keratoplasties since january 1983. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft survival
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study start15 Jan 2015
- Primary completion3 Aug 2017
- Study completion3 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KeratoconusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 564 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard Delbosc, MD, PhD, Principal investigator, Opthalmology Department, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849808
- Sponsor's protocol ID
- P/2014/230
- Acronym
- BELIEvE
- Status last verified
- Nov 2017
- First submitted
- 27 Jul 2016
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Bidaut-Garnier M, Monnet E, Prongue A, Montard R, Gauthier AS, Desmarets M, Mariet AS, Ratajczak C, Binda D, Saleh M, Delbosc B. Evolution of Corneal Graft Survival Over a 30-Year Period and Comparison of Surgical Techniques: A Cohort Study. Am J Ophthalmol. 2016 Mar;163:59-69. doi: 10.1016/j.ajo.2015.12.014. Epub 2015 Dec 17.
PubMed 26706619
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Cornea Graft Survival Study (Étude Bisontine d'Estimation de la Survie à Long Terme à Partir Des données de Suivi Internes au CHRU : Evaluation Epidémiologie Clinique)
- ClinicalTrials.gov ID
- NCT02849808
- Acronym / sponsor ID
- BELIEvE / P/2014/230
- Conditions
- Keratoconus, Fuchs' Endothelial Dystrophy
- Keywords
- Corneal Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 564 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 15 Jan 2015 (actual)
- Primary completion
- 3 Aug 2017 (actual)
- Study completion
- 3 Aug 2017 (actual)
- First posted
- 29 Jul 2016 (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.
Corneal transplantation have been performed for several decades, follow-up time in some centers now exceeds 30 years. Published long term (10 years and up) graft survivals vary considerably from center to center. These variations may be explained by differences in case-mix and surgical techniques used.
The investigators aim to better understand the factors associated with long term graft survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Keratoplasty patients | – | –All patients who underwent one or more keratoplasties since january 1983. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent one or more keratoplasties since january 1983 at the University Hospital of Besançon
Key inclusion criteria (2 listed)
- All patients who underwent one or more keratoplasties since january 1983.
- Age 18 and older
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Graft survival
Time frame: 20 years
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 17 Nov 2017.
- Results publication: PubMed 26706619Bidaut-Garnier M, Monnet E, Prongue A, Montard R, Gauthier AS, Desmarets M, Mariet AS, Ratajczak C, Binda D, Saleh M, Delbosc B. Evolution of Corneal Graft Survival Over a 30-Year Period and Comparison of Surgical Techniques: A Cohort Study. Am J Ophthalmol. 2016 Mar;163:59-69. doi: 10.1016/j.ajo.2015.12.014. Epub 2015 Dec 17.
- Individual participant dataSharing planned: Undecided
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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.
Bernard Delbosc, MD, PhD principal investigator
Opthalmology Department, CHU Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus and Fuchs' Endothelial Dystrophy, run by Centre Hospitalier Universitaire de Besancon 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 2 inclusion and 0 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 17 Nov 2017. 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?
Graft survival (time frame: 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02849808, which also lists 1 linked publication.
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 17 Nov 2017.