Study the Signs of Ocular Degeneration in a Population Co... | NCT01766596

Studies
Study the Signs of Ocular Degeneration in a Population Cohort (Dijon 3C Montrachet Cohort)

NCT01766596

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

May 1, 2024Actual

Enrollment

1,153Actual

Phase

Not Applicable

Conditions

AMD
Glaucoma

Interventions

Optical Coherence Tomography

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

Apr 2024

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

Oct 2009

Primary Completion Date

Oct 2013Actual

Completion Date

Nov 4, 2019Actual

First Submitted Date

Jan 10, 2013

First Submission Date that Met QC Criteria

Jan 10, 2013

First Posted Date

Jan 11, 2013Estimated

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

Apr 30, 2024

Last Update Posted Date

May 1, 2024Actual

Description Module

Brief Summary

The aim of the study proposed in Dijon is above all to focus on the possible relationship between age-related ocular pathologies (AMD and glaucoma) and et les degenerative neurological and cardiac pathologies.

The principal objective is to seek in subjects who have undergone cerebral MRI and echocardiography, associations between the thickness of postganglionic fibers measured by Optical Coherence Tomography at the 7th year (n=1500) and signs of cerebral impairment (psycho-cognitive tests, circulation time, MRI signs). This association will be studied after taking into account the principal environmental (particularly dietary) and genetic risk factors.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,153Actual

Label	Type	Description	Intervention Names
3C cohort	Other		Procedure: Optical Coherence Tomography

Name	Type	Description	Arm Group Labels	Other Names
Optical Coherence Tomography	Procedure		3C cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure the mean thickness of postganglionic fibers	Measure the thickness of postganglionic fibers by Optical Coherence Tomography in the 4 quadrants of the peripapillary sclera.	T=7 years of the 3C cohort

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Persons who have given their written consent
Persons who are taking part in the Dijon 3C study

Exclusion Criteria:

Persons who are not registered with social security agency
Persons who are unable to sit upright during a consultation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CHU Dijon		Dijon		21000	France

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D041623	Tomography, Optical Coherence

Ancestor Terms

ID	Term
D041622	Tomography, Optical
D061848	Optical Imaging
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided