Vision DisordersVASCONCT02485054
A Predictive Score for the Ischemic Etiology of a Transient Visual Disturbances (VASCO)
An observational study of Vision Disorders, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites in France.
Trial summary
The transient visual disturbances (TVD) are defined by a short abnormality of visual function. Their etiology may be ophthalmological, neurological non-ischemic or of ischemic origin. The difficulty is to recognize an ischemic mechanism which imposes emergency cares. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vision Disorders
- What is being tested?
- Clinical, ophthalmological and neurological evaluation
- How many people
- 403 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2015to Oct 2018
- 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: Adults having had a transient visual disturbance during the last 8 days and seen at the fondation ophtalmologique Adolphe de Rothschild
Who may be able to join
- Transient visual disturbances (i.e. less than 24 hours) during the last 8 days
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Bichat
Paris, 75018
Fondation ophtalmologique Adolphe de Rothschild
Paris, 75020
About this study
Official title: Development and Validation of a Predictive Score for the Ischemic Etiology of a Transient Visual Disturbances
The transient visual disturbances (TVD) are defined by a short abnormality of visual function. Their etiology may be ophthalmological, neurological non-ischemic or of ischemic origin.
The difficulty is to recognize an ischemic mechanism which imposes emergency cares.
A clinical score could help the clinician to recognize the etiology of the TVD .
- Conditions
- Vision Disorders
- Being tested
- Clinical, ophthalmological and neurological evaluation
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical, ophthalmological and neurological evaluationOther
Clinical : questionnaire about the symptoms and about the vascular risk factors Cerebral MRI, MRI angiography of the supra-aortic trunks, ECG, Holter, transthoracic echocardiography, blood count, erythrocytes sedimentation rate, C reactive protein, visual field, optical coherence tomography, retinography
| Study group | Role | What they receive |
|---|---|---|
| Eligible patients | Adults having had a transient visual disturbance during the last 8 days, except a diplopia Receives: Other: Clinical, ophthalmological and neurological evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Etiology, ischemic or not, of the initial transient visual disturbance
Clinical : questionnaire about the symptoms and about the vascular risk factors Cerebral MRI, MRI angiography of the supra-aortic trunks, ECG, Holter, transthoracic echocardiography, blood count, erythrocytes sedimentation rate, C reactive protein, visual field, optical coherence tomography, retinography and a new evaluation after 3 months.
Measured: 3 months
Secondary outcomes (4)
Incidence of new visual transient ischemic attacks during the 3 months of follow-up
Clinical : questionnaire about the symptoms and about the vascular risk factors Cerebral MRI, MRI angiography of the supra-aortic trunks, ECG, Holter, transthoracic echocardiography, blood count, erythrocytes sedimentation rate, C reactive protein, visual field, optical coherence tomography, retinography and a new evaluation after 3 months.
Measured: 3 months
Incidence of visual ischemic strokes during the 3 months of follow-up
Clinical : questionnaire about the symptoms and about the vascular risk factors Cerebral MRI, MRI angiography of the supra-aortic trunks, ECG, Holter, transthoracic echocardiography, blood count, erythrocytes sedimentation rate, C reactive protein, visual field, optical coherence tomography, retinography and a new evaluation after 3 months.
Measured: 3 months
Incidence of transient ischemic attacks, visual or not visual, during the 3 months of follow-up
Clinical : questionnaire about the symptoms and about the vascular risk factors Cerebral MRI, MRI angiography of the supra-aortic trunks, ECG, Holter, transthoracic echocardiography, blood count, erythrocytes sedimentation rate, C reactive protein, visual field, optical coherence tomography, retinography and a new evaluation after 3 months.
Measured: 3 months
Incidence of ischemic strokes, visual or not visual, during the 3 months of follow-up
Clinical : questionnaire about the symptoms and about the vascular risk factors Cerebral MRI, MRI angiography of the supra-aortic trunks, ECG, Holter, transthoracic echocardiography, blood count, erythrocytes sedimentation rate, C reactive protein, visual field, optical coherence tomography, retinography and a new evaluation after 3 months.
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 posted30 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision DisordersStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 403 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
- NCT02485054
- Sponsor's protocol ID
- MOA_2014-32
- Acronym
- VASCO
- Status last verified
- Mar 2019
- First submitted
- 18 Jun 2015
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Predictive Score for the Ischemic Etiology of a Transient Visual Disturbances
- ClinicalTrials.gov ID
- NCT02485054
- Acronym / sponsor ID
- VASCO / MOA_2014-32
- Conditions
- Vision Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Sep 2015 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 30 Jun 2015 (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 transient visual disturbances (TVD) are defined by a short abnormality of visual function. Their etiology may be ophthalmological, neurological non-ischemic or of ischemic origin.
The difficulty is to recognize an ischemic mechanism which imposes emergency cares.
A clinical score could help the clinician to recognize the etiology of the TVD .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible patients | – | Other: Clinical, ophthalmological and neurological evaluationAdults having had a transient visual disturbance during the last 8 days, except a diplopia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults having had a transient visual disturbance during the last 8 days and seen at the fondation ophtalmologique Adolphe de Rothschild
Key inclusion criteria (1 listed)
- Transient visual disturbances (i.e. less than 24 hours) during the last 8 days
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Clinical, ophthalmological and neurological evaluationClinical : questionnaire about the symptoms and about the vascular risk factors Cerebral MRI, MRI angiography of the supra-aortic trunks, ECG, Holter, transthoracic echocardiography, blood count, erythrocytes sedimentation rate, C reactive protein, visual field, optical coherence tomography, retinography | Other | Eligible patients |
Primary outcome
Etiology, ischemic or not, of the initial transient visual disturbance
Time frame: 3 months
Clinical : questionnaire about the symptoms and about the vascular risk factors Cerebral MRI, MRI angiography of the supra-aortic trunks, ECG, Holter, transthoracic echocardiography, blood count, erythrocytes sedimentation rate, C reactive protein, visual field, optical coherence tomography, retinography and a new evaluation after 3 months.
4 secondary outcomes
Incidence of new visual transient ischemic attacks during the 3 months of follow-up
Time frame: 3 months
Incidence of visual ischemic strokes during the 3 months of follow-up
Time frame: 3 months
Incidence of transient ischemic attacks, visual or not visual, during the 3 months of follow-up
Time frame: 3 months
Incidence of ischemic strokes, visual or not visual, during the 3 months of follow-up
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 25 Mar 2019.
Related trials for Vision Disorders
Active, not recruiting
Study of Near-Infrared Imaging With Indocyanine Green for Detection of Sentinel Lymph Nodes in People With Vulvar Cancer
Vulvar Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Ocular Myasthenia Gravis
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vision Disorders, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites 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 1 inclusion and 1 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 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Etiology, ischemic or not, of the initial transient visual disturbance (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 25 Mar 2019.