Optical Coherence TomographyRETEVALNCT04794634
Relationship Between Alzheimer Disease and Diminution of the Three Macular Nervous Retinal Layers
A study testing Optical coherence tomography (OCT) and Optical coherence tomograpohy angiography (OCTA) in people with Optical Coherence Tomography and Optical Coherence Tomography Angiography, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Alzheimer disease is hard, long and expensive to diagnose. In order to help the clinician, a new biomarker in Alzheimer disease seems to be very useful. The retina, as a window of the brain, could offer a new way to diagnose this common disease. Indeed, a retinal atrophy could especially appear in Alzheimer disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Optical Coherence Tomography, Optical Coherence Tomography Angiography, Retinal Thickening
- What is being tested?
- Optical coherence tomography (OCT) and Optical coherence tomograpohy angiography (OCTA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2021to 1 Dec 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients having a consultation in the Research and Resources Memory Center of Amiens (RRMC) ,
- patients registered in the Alzheimer National Bank and having an Alzheimer Disease based on NIA-AA (McKahnn2011)and IWG2 (Dubois et al, 2014) criteria or, having a Lewy body disease based on revised criteria of McKeith et al 2020
- patients having a complete neuropsychological evaluation including a visual inspection time.
- patients having a MMSE ≥ 18/30 so as to ensure a good homogeneity of the group and to have an adequate ocular exam's quality.
- patients having an available MRI in the CHU's database including a 3DT1 sequence
- patients having a visual acuity better than 5/10, spherical refraction of +/- 5D, an astigmatism < 3D and an applanation IOP <22mmHg
Who cannot join
- Any other neurocognitive disorder
- Any other optical neuropathy including glaucoma
- All kind of retinal disease (diabetic retinopathy, age-related macular degeneration…)
- Diabetes mellitus
- Uncontrolled hypertension blood pressure
- Any ophthalmological conditions interfering with a good ocular examination or OCT quality (cataract, corneal opacity..)
Show all 9Show fewer
- Severe dementia preventing a good ophthalmological examination
- Not consenting patient
- Patient with guardianship or curatorship having symptoms preventing a good ophthalmological examination (agitation, unstable ocular fixation)
Trial locations and contacts
1 site in 1 country.
About this study
Alzheimer disease is hard, long and expensive to diagnose. In order to help the clinician, a new biomarker in Alzheimer disease seems to be very useful. The retina, as a window of the brain, could offer a new way to diagnose this common disease. Indeed, a retinal atrophy could especially appear in Alzheimer disease. Besides, many aspects about retinal alteration, visual function and their link with the disease deserve to be more explored. So as to fill these gaps, a new study about retinal specificity in Alzheimer disease appears to be relevant.
- Conditions
- Optical Coherence Tomography, Optical Coherence Tomography Angiography, Retinal Thickening, Alzheimer Disease, Lewy Body Disease, Retina
- Being tested
- Optical coherence tomography (OCT), Optical coherence tomograpohy angiography (OCTA)
- Keywords
- Optical coherence tomography, Optical coherence tomography angiography, Retinal Thickening, Alzheimer Disease, Lewy Body Disease, Retina, Cortical Atrophy, Retinal Nerve Fibres Layer, Cell Ganglion Layer, Intern Plexiform Layer
- Medical subject headings
- Alzheimer Disease, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography (OCT)Diagnostic test
to make a complete ophthalmological and neurological examination, an OCT to AD and to compare their results with LD and controls subjects
Optical coherence tomograpohy angiography (OCTA)Diagnostic test
to make a complete ophthalmological and neurological examination, an OCT and OCTA, to AD and to compare their results with LD and controls subjects
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer Disease | Experimental | Not described Receives: Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Optical coherence tomograpohy angiography (OCTA) |
| Lewy body disease | Experimental | Not described Receives: Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Optical coherence tomograpohy angiography (OCTA) |
| healthy patient | Active comparator | Not described Receives: Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Optical coherence tomograpohy angiography (OCTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of retinal nerve fibres layer (RNFL) thickness in AD patient compared to healthy and LMD patients
Thickness of retinal nerve fibres layer (RNFL), ganglion cell layer (CGL), intern plexiform layer (IPL) within the macular zone of patients suffering from AD.
Measured: one day
Variation of ganglion cell layer (CGL) thickness in AD patient compared to healthy and LMD patients
Thickness of retinal nerve fibres layer (RNFL), ganglion cell layer (CGL), intern plexiform layer (IPL) within the macular zone of patients suffering from AD.
Measured: one day
Variation of intern plexiform layer (IPL) thickness in AD patient compared to healthy and LMD patients
Thickness of retinal nerve fibres layer (RNFL), ganglion cell layer (CGL), intern plexiform layer (IPL) within the macular zone of patients suffering from AD.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start13 Jan 2021
- Primary completion23 Jun 2023
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optical Coherence TomographyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794634
- Sponsor's protocol ID
- PI2021_843_0006
- Acronym
- RETEVAL
- Status last verified
- Dec 2025
- First submitted
- 9 Mar 2021
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Alzheimer Disease and Diminution of the Three Macular Nervous Retinal Layers
- ClinicalTrials.gov ID
- NCT04794634
- Acronym / sponsor ID
- RETEVAL / PI2021_843_0006
- Conditions
- Optical Coherence Tomography, Optical Coherence Tomography Angiography, Retinal Thickening, Alzheimer Disease, Lewy Body Disease, Retina
- Keywords
- Optical coherence tomography, Optical coherence tomography angiography, Retinal Thickening, Alzheimer Disease, Lewy Body Disease, Retina, Cortical Atrophy, Retinal Nerve Fibres Layer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 12 Mar 2021 (actual)
- 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.
Alzheimer disease is hard, long and expensive to diagnose. In order to help the clinician, a new biomarker in Alzheimer disease seems to be very useful. The retina, as a window of the brain, could offer a new way to diagnose this common disease. Indeed, a retinal atrophy could especially appear in Alzheimer disease. Besides, many aspects about retinal alteration, visual function and their link with the disease deserve to be more explored. So as to fill these gaps, a new study about retinal specificity in Alzheimer disease appears to be relevant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alzheimer Disease | Experimental | Diagnostic Test: Optical coherence tomography (OCT), Diagnostic Test: Optical coherence tomograpohy angiography (OCTA) |
| Lewy body disease | Experimental | Diagnostic Test: Optical coherence tomography (OCT), Diagnostic Test: Optical coherence tomograpohy angiography (OCTA) |
| healthy patient | Active comparator | Diagnostic Test: Optical coherence tomography (OCT), Diagnostic Test: Optical coherence tomograpohy angiography (OCTA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients having a consultation in the Research and Resources Memory Center of Amiens (RRMC) ,
- patients registered in the Alzheimer National Bank and having an Alzheimer Disease based on NIA-AA (McKahnn2011)and IWG2 (Dubois et al, 2014) criteria or, having a Lewy body disease based on revised criteria of McKeith et al 2020
- patients having a complete neuropsychological evaluation including a visual inspection time.
- patients having a MMSE ≥ 18/30 so as to ensure a good homogeneity of the group and to have an adequate ocular exam's quality.
- patients having an available MRI in the CHU's database including a 3DT1 sequence
Key exclusion criteria (9 listed)
- Any other neurocognitive disorder
- Any other optical neuropathy including glaucoma
- All kind of retinal disease (diabetic retinopathy, age-related macular degeneration…)
- Diabetes mellitus
- Uncontrolled hypertension blood pressure
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 (OCT)to make a complete ophthalmological and neurological examination, an OCT to AD and to compare their results with LD and controls subjects | Diagnostic test | Alzheimer Disease, Lewy body disease, healthy patient |
| Optical coherence tomograpohy angiography (OCTA)to make a complete ophthalmological and neurological examination, an OCT and OCTA, to AD and to compare their results with LD and controls subjects | Diagnostic test | Alzheimer Disease, Lewy body disease, healthy patient |
Primary outcome
Variation of retinal nerve fibres layer (RNFL) thickness in AD patient compared to healthy and LMD patients
Time frame: one day
Thickness of retinal nerve fibres layer (RNFL), ganglion cell layer (CGL), intern plexiform layer (IPL) within the macular zone of patients suffering from AD.
Variation of ganglion cell layer (CGL) thickness in AD patient compared to healthy and LMD patients
Time frame: one day
Thickness of retinal nerve fibres layer (RNFL), ganglion cell layer (CGL), intern plexiform layer (IPL) within the macular zone of patients suffering from AD.
Variation of intern plexiform layer (IPL) thickness in AD patient compared to healthy and LMD patients
Time frame: one day
Thickness of retinal nerve fibres layer (RNFL), ganglion cell layer (CGL), intern plexiform layer (IPL) within the macular zone of patients suffering from AD.
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 8 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Optical Coherence Tomography
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingObservational study
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
Keratitis Bacterial, Keratitis Fungal
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Recruiting
4D Duke Microscope Integrated Optical Coherence Tomography in a Zeiss Artevo 800
Corneal Diseases, Retinal Diseases
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
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 (OCT) and Optical coherence tomograpohy angiography (OCTA) in people with Optical Coherence Tomography and Optical Coherence Tomography Angiography, run by Centre Hospitalier Universitaire, Amiens 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 6 inclusion and 9 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 8 Dec 2025. 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?
Variation of retinal nerve fibres layer (RNFL) thickness in AD patient compared to healthy and LMD patients (time frame: one day). The study lists 3 primary outcomes in all. 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 8 Dec 2025.