Actively Recruiting

Age: 18Years +
All Genders
ID02576925

Development and Validation of a Predictive Score for the Ischemic Cause of Transient Diplopia

Led by Fondation Ophtalmologique Adolphe de Rothschild · Updated on 2025-06-25

220

Participants Needed

2

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying transient diplopia, which is a brief episode of double vision, to understand its causes. This study focuses on distinguishing whether the diplopia is due to ischemic causes, which require urgent care, or other origins such as ophthalmological or non-ischemic neurological reasons. The goal is to develop a clinical score that helps doctors identify an ischemic cause quickly and accurately. Participants will undergo clinical, ophthalmological, and neurological evaluations. These include questionnaires about symptoms and vascular risk factors, brain imaging such as MRI and MRI angiography, heart monitoring with ECG and Holter, echocardiography, and various blood tests. Eye exams include visual field tests, optical coherence tomography, and retinography. The study observes adults who have experienced transient diplopia within the last 8 days. During the study, participants will be followed for 3 months to monitor the cause of their initial diplopia and any new ischemic events, including transient diplopia attacks, ischemic strokes, or transient ischemic attacks affecting vision or other functions. The main outcome is identifying whether the diplopia had an ischemic cause. Safety and ongoing health are monitored through these assessments over the follow-up period.

CONDITIONS

Brief Title

A Predictive Score for the Ischemic Etiology of a Transient Diplopia (VASCO-DIP)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Experienced transient diplopia lasting less than 24 hours within the last 8 days
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Within the first 8 days after transient diplopia

Participants undergo clinical, ophthalmological, and neurological evaluations including questionnaires, cerebral MRI, MRI angiography, ECG, Holter monitoring, echocardiography, blood tests, and ophthalmologic assessments.

1 visit (in-person)

Long-term Monitoring

Duration - 3 months

Participants are monitored for 3 months to observe the incidence of ischemic events related to transient diplopia.

Follow-up visits as needed over 3 months

Trial Site Locations

Total: 2 locations

1

Hôpital Bichat

Paris, France, 75018

Actively Recruiting

2

Fondation Ophtalmologique Adolphe de Rothschild

Paris, Île-de-France Region, France, 75019

Actively Recruiting

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Research Team

M

Michel Rosenheim, MD, DSc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Frequently Asked Questions

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