Long Term Cornea Graft Survival Study | NCT02849808

Studies
Long Term Cornea Graft Survival Study

NCT02849808

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Completed

Last Update Posted

Nov 17, 2017Actual

Enrollment

564Actual

Phase

Not provided

Conditions

Keratoconus
Fuchs' Endothelial Dystrophy

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2015Actual

Primary Completion Date

Aug 3, 2017Actual

Completion Date

Aug 3, 2017Actual

First Submitted Date

Jul 27, 2016

First Submission Date that Met QC Criteria

Jul 28, 2016

First Posted Date

Jul 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2017

Last Update Posted Date

Nov 17, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

564Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Keratoplasty patients		All patients who underwent one or more keratoplasties since january 1983.

Interventions

Not provided

Measure	Description	Time Frame
Graft survival		20 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bernard Delbosc, MD, PhD	Opthalmology Department, CHU Besançon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ophthalmology Departement, CHU Besançon		Besançon		25030	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26706619	Result	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.

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases
D003317	Corneal Dystrophies, Hereditary
D015785	Eye Diseases, Hereditary

ID	Term
D007640	Keratoconus
D005642	Fuchs' Endothelial Dystrophy