StrokeOCTAVNCT03964610
Multimodal Retinal Imaging of Cerebrovascular Stroke
An observational study of Stroke and Cerebrovascular Accidents, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The hypothesis is that in patients with stroke, abnormalities of retinal microvascularization shown on color fundus photography and the depletion of retinal capillary density evaluated by OCT-A are markers of acute impairment of microcirculation of the central nervous system and are correlated with lesions on brain… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebrovascular Accidents
- What is being tested?
- color fundus photography (CFP) and OCT-A
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2019to 15 Feb 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Acute patients with a stroke will be included
Who may be able to join
- Acute ischemic stroke
- With cerebral microangiopathy (defined by a SVD score > 1)
Who cannot join
- Acute hemorrhagic stroke
- Anophthalmia
Trial locations and contacts
1 site in 1 country.
About this study
The hypothesis is that in patients with stroke, abnormalities of retinal microvascularization shown on color fundus photography and the depletion of retinal capillary density evaluated by OCT-A are markers of acute impairment of microcirculation of the central nervous system and are correlated with lesions on brain imaging.
Patients hospitalized for stroke MRI-confirmed, will be included. An ophthalmologic assessment including color fundus photography (CFP) and OCT-A will be carried out after stabilization and at 3 months follow-up. Outcomes assessor will be blinded.
- Conditions
- Stroke, Cerebrovascular Accidents
- Being tested
- color fundus photography (CFP) and OCT-A
- Keywords
- optical coherence tomography (OCT-A), color fundus photography (CFP), Retinal microvascularization, Cerebral microangiopathy
- Medical subject headings
- Stroke, Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
color fundus photography (CFP) and OCT-ADiagnostic test
Included patients will have an ophthalmologic assessment (OCT-A and CPF) after stabilization and at 3 months follow-up.
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of an anomaly in color fundus photography or an anomaly of retinal capillary density to OCT-A
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start15 Nov 2019
- Primary completion15 Nov 2021
- Study completion15 Feb 2022
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964610
- Sponsor's protocol ID
- RHE_2019_10
- Acronym
- OCTAV
- Status last verified
- Mar 2022
- First submitted
- 24 May 2019
- Last updated
- 3 Mar 2022
- Results posted
- 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 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Retinal Imaging of Cerebrovascular Stroke
- ClinicalTrials.gov ID
- NCT03964610
- Acronym / sponsor ID
- OCTAV / RHE_2019_10
- Conditions
- Stroke, Cerebrovascular Accidents
- Keywords
- optical coherence tomography (OCT-A), color fundus photography (CFP), Retinal microvascularization, Cerebral microangiopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 28 May 2019 (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 hypothesis is that in patients with stroke, abnormalities of retinal microvascularization shown on color fundus photography and the depletion of retinal capillary density evaluated by OCT-A are markers of acute impairment of microcirculation of the central nervous system and are correlated with lesions on brain imaging.
Patients hospitalized for stroke MRI-confirmed, will be included. An ophthalmologic assessment including color fundus photography (CFP) and OCT-A will be carried out after stabilization and at 3 months follow-up. Outcomes assessor will be blinded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute patients with a stroke will be included
Key inclusion criteria (2 listed)
- Acute ischemic stroke
- With cerebral microangiopathy (defined by a SVD score > 1)
Key exclusion criteria (2 listed)
- Acute hemorrhagic stroke
- Anophthalmia
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 |
|---|---|---|
| color fundus photography (CFP) and OCT-AIncluded patients will have an ophthalmologic assessment (OCT-A and CPF) after stabilization and at 3 months follow-up. | Diagnostic test | – |
Primary outcome
Presence of an anomaly in color fundus photography or an anomaly of retinal capillary density to OCT-A
Time frame: 3 months
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 3 Mar 2022.
- Individual participant dataSharing planned: No
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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?
An observational study of Stroke and Cerebrovascular Accidents, 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 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 3 Mar 2022. 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?
Presence of an anomaly in color fundus photography or an anomaly of retinal capillary density to OCT-A (time frame: 3 months). 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 3 Mar 2022.