DiplopiaVASCO-DIPNCT02576925
A Predictive Score for the Ischemic Etiology of a Transient Diplopia (VASCO-DIP)
An observational study of Diplopia, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites in France.
Trial summary
The transient diplopias (TD) is defined by a short diplopia. 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 TD . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diplopia
- What is being tested?
- Clinical, ophthalmological and neurological evaluation
- How many people
- 220 participants
- Where
- 2 sitesFrance
- Study dates
- 24 Sep 2015to 23 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 diplopia during the last 8 days and seen at the fondation ophtalmologique Adolphe de Rothschild
Who may be able to join
- Transient diplopia (i.e. less than 24 hours) during the last 8 days
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hôpital Bichat
Paris, 75018
Pierre AMARENCO, MD
- Recruiting
Fondation Ophtalmologique Adolphe de Rothschild
Paris, Île-de-France Region, 75019
Mickaël Obadia, MD, 0033148036431, mobadia@fo-rothschild.fr
About this study
Official title: Development and Validation of a Predictive Score for the Ischemic Etiology of a Transient Diplopia
The transient diplopias (TD) is defined by a short diplopia. 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 TD .
- Conditions
- Diplopia
- Being tested
- Clinical, ophthalmological and neurological evaluation
- Medical subject headings
- Diplopia
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 Imagery :Cerebral MRI, MRI angiography of the supra-aortic trunks, ECG, Holter, transthoracic echocardiography, Biology : blood count, erythrocytes sedimentation rate, C reactive protein Ophthalomogy : visual field, optical coherence tomography, retinography
| Study group | Role | What they receive |
|---|---|---|
| Eligible patients | Adults having had a transient diplopia during the last 8 days. 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 diplopia
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 transient diplopia ischemic attacks during the 3 months of follow-up
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 diplopia ischemic strokes during the 3 months of follow-up
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
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
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 posted15 Oct 2015 (estimated)
- Study start24 Sep 2015
- Primary completion23 Feb 2027 (estimated)
- Study completion23 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiplopiaStudies 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
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576925
- Sponsor's protocol ID
- MOA_2015-7
- Acronym
- VASCO-DIP
- Status last verified
- Sep 2026
- First submitted
- 13 Oct 2015
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. 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 Diplopia
- ClinicalTrials.gov ID
- NCT02576925
- Acronym / sponsor ID
- VASCO-DIP / MOA_2015-7
- Conditions
- Diplopia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 24 Sep 2015 (actual)
- Primary completion
- 23 Feb 2027 (estimated)
- Study completion
- 23 Mar 2027 (estimated)
- First posted
- 15 Oct 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 diplopias (TD) is defined by a short diplopia. 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 TD .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible patients | – | Other: Clinical, ophthalmological and neurological evaluationAdults having had a transient diplopia during the last 8 days. |
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 diplopia during the last 8 days and seen at the fondation ophtalmologique Adolphe de Rothschild
Key inclusion criteria (1 listed)
- Transient diplopia (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 Imagery :Cerebral MRI, MRI angiography of the supra-aortic trunks, ECG, Holter, transthoracic echocardiography, Biology : blood count, erythrocytes sedimentation rate, C reactive protein Ophthalomogy : visual field, optical coherence tomography, retinography | Other | Eligible patients |
Primary outcome
Etiology, ischemic or not, of the initial transient diplopia
Time frame: 3 months
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 transient diplopia ischemic attacks during the 3 months of follow-up
Time frame: 3 months
Incidence of diplopia 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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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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.
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 Diplopia, 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michel Rosenheim, MD, DSc (+33148036457, mrosenheim@fo-rothschild.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Etiology, ischemic or not, of the initial transient diplopia (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 9 Sep 2026.