NCT02849808

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
564

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

2.6 years

First QC Date

July 27, 2016

Last Update Submit

November 14, 2017

Conditions

KeratoconusFuchs' Endothelial Dystrophy

Keywords

Corneal Transplantation

Outcome Measures

Primary Outcomes (1)

  • Graft survival

    20 years

Study Arms (1)

Keratoplasty patients

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who underwent one or more keratoplasties since january 1983 at the University Hospital of Besançon

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology Departement, CHU Besançon

Besançon, 25030, France

Location

Related Publications (1)

  • 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.

    PMID: 26706619RESULT

MeSH Terms

Conditions

KeratoconusFuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesCorneal Dystrophies, HereditaryEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Bernard Delbosc, MD, PhD

    Opthalmology Department, CHU Besançon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2016

First Posted

July 29, 2016

Study Start

January 15, 2015

Primary Completion

August 3, 2017

Study Completion

August 3, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

FR(1)