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BELIEvE: Long Term Cornea Graft Survival Study

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Completed
CT.gov ID
NCT02849808
Collaborator
(none)
564
Enrollment
1
Location
30.6
Actual Duration (Months)
18.4
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    564 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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 :
    Jan 15, 2015
    Actual Primary Completion Date :
    Aug 3, 2017
    Actual Study Completion Date :
    Aug 3, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Keratoplasty patients

    All patients who underwent one or more keratoplasties since january 1983.

    Outcome Measures

    Primary Outcome Measures

    1. Graft survival [20 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • All patients who underwent one or more keratoplasties since january 1983.

    • Age 18 and older

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ophthalmology Departement, CHU Besançon Besançon France 25030

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Besancon

    Investigators

    • Principal Investigator: Bernard Delbosc, MD, PhD, Opthalmology Department, CHU Besançon

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Besancon
    ClinicalTrials.gov Identifier:
    NCT02849808
    Other Study ID Numbers:
    • P/2014/230
    First Posted:
    Jul 29, 2016
    Last Update Posted:
    Nov 17, 2017
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Centre Hospitalier Universitaire de Besancon
    Corneal Transplantation
    Additional relevant MeSH terms:
    Keratoconus
    Fuchs' Endothelial Dystrophy

    Study Results

    No Results Posted as of Nov 17, 2017