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Long Term Cornea Graft Survival Study (BELIEvE)

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ClinicalTrials.gov Identifier: NCT02849808
Recruitment Status : Completed
First Posted : July 29, 2016
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief 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.

The investigators aim to better understand the factors associated with long term graft survival.


Condition or disease
Keratoconus Fuchs' Endothelial Dystrophy

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Study Type : Observational [Patient Registry]
Actual Enrollment : 564 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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)
Actual Study Start Date : January 15, 2015
Actual Primary Completion Date : August 3, 2017
Actual Study Completion Date : August 3, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Keratoplasty patients
All patients who underwent one or more keratoplasties since january 1983.



Primary Outcome Measures :
  1. Graft survival [ Time Frame: 20 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who underwent one or more keratoplasties since january 1983 at the University Hospital of Besançon
Criteria

Inclusion Criteria:

  • All patients who underwent one or more keratoplasties since january 1983.
  • Age 18 and older

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849808


Locations
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France
Ophthalmology Departement, CHU Besançon
Besançon, France, 25030
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Bernard Delbosc, MD, PhD Opthalmology Department, CHU Besançon

Additional Information:

Publications of Results:
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02849808     History of Changes
Other Study ID Numbers: P/2014/230
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Centre Hospitalier Universitaire de Besancon:
Corneal Transplantation

Additional relevant MeSH terms:
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Keratoconus
Fuchs' Endothelial Dystrophy
Corneal Diseases
Eye Diseases
Corneal Dystrophies, Hereditary
Eye Diseases, Hereditary
Genetic Diseases, Inborn