AMD3CNCT01766596
Study the Signs of Ocular Degeneration in a Population Cohort (Dijon 3C Montrachet Cohort)
A study testing Optical Coherence Tomography in people with AMD and Glaucoma, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Optical Coherence Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,153 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to 4 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Persons who have given their written consent
- Persons who are taking part in the Dijon 3C study
Who cannot join
- Persons who are not registered with social security agency
- Persons who are unable to sit upright during a consultation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study the Signs of Ocular Degeneration in a Population Cohort (Dijon 3C Montrachet Cohort): Seek Correlations Between Signs of Neurological and Vascular Degeneration and Signs of Ocular Aging
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.
- Being tested
- Optical Coherence Tomography
- Keywords
- Ophthalmology, Age-related ocular pathologies
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence TomographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 3C cohort | Other | Not described Receives: Procedure: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T=7 years of the 3C cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startOct 2009
- Primary completionOct 2013
- Study completion4 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMDStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766596
- Sponsor's protocol ID
- Creuzot-Garcher PHRC IR 2009
- Acronym
- 3C
- Status last verified
- Apr 2024
- First submitted
- 10 Jan 2013
- Last updated
- 1 May 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study the Signs of Ocular Degeneration in a Population Cohort (Dijon 3C Montrachet Cohort): Seek Correlations Between Signs of Neurological and Vascular Degeneration and Signs of Ocular Aging
- ClinicalTrials.gov ID
- NCT01766596
- Acronym / sponsor ID
- 3C / Creuzot-Garcher PHRC IR 2009
- Keywords
- Ophthalmology, Age-related ocular pathologies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,153 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3C cohort | Other | Procedure: Optical Coherence Tomography |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Persons who have given their written consent
- Persons who are taking part in the Dijon 3C study
Key exclusion criteria (2 listed)
- Persons who are not registered with social security agency
- Persons who are unable to sit upright during a consultation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical Coherence Tomography | Procedure or surgery | 3C cohort |
Primary outcome
Measure the mean thickness of postganglionic fibers
Time frame: T=7 years of the 3C cohort
Measure the thickness of postganglionic fibers by Optical Coherence Tomography in the 4 quadrants of the peripapillary sclera.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical Coherence Tomography in people with AMD and Glaucoma, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the mean thickness of postganglionic fibers (time frame: T=7 years of the 3C cohort). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.