StrokeSTROKAONCT04712747
Adaptive Optics (AO) Analysis of Retinal Arteries in Patients With Recent Stroke (STROKAO)
An observational study of Stroke, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The eye has long been recognized as a window to pathological processes occurring in the brain. By imaging the vascular system of the retina scientific understanding and clinical practice have been improved for a wide range of pathologies from diabetes to stroke and dementia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Ophthalmological examinations and Blood pressure measurement at rest
- Type of treatment
- Surgery or procedure
- How many people
- 91 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2021to 14 Jan 2025
- Phase
- Observational
- 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
Study population: Inpatients with confirmed stroke for less than 10 days and controls (Individuals presenting at the Rothschild Foundation Hospital with no history of stroke)
Who may be able to join
- For the patients with stroke: Inpatients with confirmed stroke (clinical and imaging) for less than 10 days
- For the controls: Individuals presenting at the Rothschild Foundation Hospital with no history of stroke who are matched to cases already included in the matching criteria: Age ± 5 years, Gender, high blood pressure (no history, untreated, treated) Diabetes (Yes, No), Body Mass Index (BMI < 25, 25 ≥ BMI < 30, BMI ≥ 30)
Who cannot join
- Pregnant or breastfeeding woman
- Insufficient state of consciousness or physical condition to perform the adaptive optics examination
- For the patients with stroke: Hemorrhagic post-traumatic hematoma stroke type, or symptomatic stroke of a brain tumour or an arteriovenous malformation.
Trial locations and contacts
1 site in 1 country.
About this study
The eye has long been recognized as a window to pathological processes occurring in the brain. By imaging the vascular system of the retina scientific understanding and clinical practice have been improved for a wide range of pathologies from diabetes to stroke and dementia.
Adaptive optics (AO) reveals retinal details that remain invisible with other current imaging techniques. Indeed, vessels can be perfectly visualized, making it possible to detect wall irregularities, accurately measure their different structures and monitor their evolution under treatment if necessary.
Read more
In AO, studies on retinal vessels involve the calculation of wall thickness (WT), outer diameter (OD), inner diameter (ID), wall cross-sectional area (WCSA) and wall to lumen ratio (WLR). An increase in WLR > 0.31 is characteristic of hypertensive microangiopathy and predictive of cardiovascular and brain damage. This accurate assessment of microvascular structure may even be required in the near future in all patients with arterial hypertension. For vessels > 300 microns in diameter, the increase in vessel wall thickness occurs without changing the ID, a process known as external hypertrophic remodeling. For small arteries < 300 microns, remodeling occurs differently. The total volume of the vessel wall remains constant, but the OD and ID each decrease, a process known as inward eutrophic remodeling.
The objective of this study is to describe the parameters measured in AO in patients in the acute phase of a stroke and then at 3 months.
- Conditions
- Stroke
- Being tested
- Ophthalmological examinations, Blood pressure measurement at rest
- Keywords
- Adaptive optics
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmological examinationsProcedure or surgery
- OCT (Optical Coherence Tomography): posterior pole OCT B scan , optic nerve and posterior pole OCT Angiography
- Adaptive optics (AO) : Image acquisition on the vessels at the exit of the optic nerve before the first upper temporal bifurcation OD or OG and evaluation of the photoreceptor mosaic. Adaptive optics may require dilatation of the pupil with a drop of tropicamide in the eye examined a few minutes before the examination.
- Color retinophotography
- Measurement of intraocular pressure
Patients with stroke : At the inclusion visit and 3 months after their stroke Control group : At the inclusion visit.
Blood pressure measurement at restProcedure or surgery
At the inclusion visit
| Study group | Role | What they receive |
|---|---|---|
| Cases - patients with stroke | Ophthalmological examinations : At the inclusion visit and 3 months after their stroke Blood pressure measurement at rest : At the inclusion visit Receives: Procedure: Ophthalmological examinations; Procedure: Blood pressure measurement at rest | |
| Controls - Individuals with no history of stroke | Ophthalmological examinations : At the inclusion visit Blood pressure measurement at rest : At the inclusion visit Receives: Procedure: Ophthalmological examinations; Procedure: Blood pressure measurement at rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wall thickness (WT) in adaptive optics
Measured in µm², Comparison between groups : hemorrhagic strokes, ischemic strokes, controls
Measured: At the inclusion visit (less than 10 days after the stroke for the patients with stroke)
Wall cross-sectional area (WCSA) in adaptive optics
Measured in µm², Comparison between groups : hemorrhagic strokes, ischemic strokes, controls
Measured: At the inclusion visit (less than 10 days after the stroke for the patients with stroke)
Wall to lumen ratio (WLR) in adaptive optics
Comparison between groups : hemorrhagic strokes, ischemic strokes, controls
Measured: At the inclusion visit (less than 10 days after the stroke for the patients with stroke)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start25 Jan 2021
- Primary completion14 Jan 2025
- Study completion14 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Martine MAUGET FAYSSE, MD, Principal investigator, Hôpital Fondation A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712747
- Sponsor's protocol ID
- MMT_2020_28
- Acronym
- STROKAO
- Status last verified
- Dec 2025
- First submitted
- 14 Jan 2021
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Optics (AO) Analysis of Retinal Arteries in Patients With Recent Stroke (STROKAO)
- ClinicalTrials.gov ID
- NCT04712747
- Acronym / sponsor ID
- STROKAO / MMT_2020_28
- Conditions
- Stroke
- Keywords
- Adaptive optics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 14 Jan 2025 (actual)
- Study completion
- 14 Jan 2025 (actual)
- First posted
- 15 Jan 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.
The eye has long been recognized as a window to pathological processes occurring in the brain. By imaging the vascular system of the retina scientific understanding and clinical practice have been improved for a wide range of pathologies from diabetes to stroke and dementia.
Adaptive optics (AO) reveals retinal details that remain invisible with other current imaging techniques. Indeed, vessels can be perfectly visualized, making it possible to detect wall irregularities, accurately measure their different structures and monitor their evolution under treatment if necessary.
In AO, studies on retinal vessels involve the calculation of wall thickness (WT), outer diameter (OD), inner diameter (ID), wall cross-sectional area (WCSA) and wall to lumen ratio (WLR). An increase in WLR > 0.31 is characteristic of hypertensive microangiopathy and predictive of cardiovascular and brain damage. This accurate assessment of microvascular structure may even be required in the near future in all patients with arterial hypertension. For vessels > 300 microns in diameter, the increase in vessel wall thickness occurs without changing the ID, a process known as external hypertrophic remodeling. For small arteries < 300 microns, remodeling occurs differently. The total volume of the vessel wall remains constant, but the OD and ID each decrease, a process known as inward eutrophic remodeling.
The objective of this study is to describe the parameters measured in AO in patients in the acute phase of a stroke and then at 3 months.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases - patients with stroke | – | Procedure: Ophthalmological examinations, Procedure: Blood pressure measurement at restOphthalmological examinations : At the inclusion visit and 3 months after their stroke Blood pressure measurement at rest : At the inclusion visit |
| Controls - Individuals with no history of stroke | – | Procedure: Ophthalmological examinations, Procedure: Blood pressure measurement at restOphthalmological examinations : At the inclusion visit Blood pressure measurement at rest : At the inclusion visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients with confirmed stroke for less than 10 days and controls (Individuals presenting at the Rothschild Foundation Hospital with no history of stroke)
Key inclusion criteria (2 listed)
- For the patients with stroke: Inpatients with confirmed stroke (clinical and imaging) for less than 10 days
- For the controls: Individuals presenting at the Rothschild Foundation Hospital with no history of stroke who are matched to cases already included in the matching criteria: Age ± 5 years, Gender, high blood pressure (no history, untreated, treated) Diabetes (Yes, No), Body Mass Index (BMI < 25, 25 ≥ BMI < 30, BMI ≥ 30)
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding woman
- Insufficient state of consciousness or physical condition to perform the adaptive optics examination
- For the patients with stroke: Hemorrhagic post-traumatic hematoma stroke type, or symptomatic stroke of a brain tumour or an arteriovenous malformation.
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 |
|---|---|---|
| Ophthalmological examinations* OCT (Optical Coherence Tomography): posterior pole OCT B scan , optic nerve and posterior pole OCT Angiography * Adaptive optics (AO) : Image acquisition on the vessels at the exit of the optic nerve before the first upper temporal bifurcation OD or OG and evaluation of the photoreceptor mosaic. Adaptive optics may require dilatation of the pupil with a drop of tropicamide in the eye examined a few minutes before the examination. * Color retinophotography * Measurement of intraocular pressure Patients with stroke : At the inclusion visit and 3 months after their stroke Control group : At the inclusion visit. | Procedure or surgery | Cases - patients with stroke, Controls - Individuals with no history of stroke |
| Blood pressure measurement at restAt the inclusion visit | Procedure or surgery | Cases - patients with stroke, Controls - Individuals with no history of stroke |
Primary outcome
Wall thickness (WT) in adaptive optics
Time frame: At the inclusion visit (less than 10 days after the stroke for the patients with stroke)
Measured in µm², Comparison between groups : hemorrhagic strokes, ischemic strokes, controls
Wall cross-sectional area (WCSA) in adaptive optics
Time frame: At the inclusion visit (less than 10 days after the stroke for the patients with stroke)
Measured in µm², Comparison between groups : hemorrhagic strokes, ischemic strokes, controls
Wall to lumen ratio (WLR) in adaptive optics
Time frame: At the inclusion visit (less than 10 days after the stroke for the patients with stroke)
Comparison between groups : hemorrhagic strokes, ischemic strokes, controls
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 10 Dec 2025.
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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.
Martine MAUGET FAYSSE, MD principal investigator
Hôpital Fondation A. de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Fondation Ophtalmologique Adolphe de Rothschild 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 3 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 10 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?
Wall thickness (WT) in adaptive optics (time frame: At the inclusion visit (less than 10 days after the stroke for the patients with stroke)). 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 10 Dec 2025.