Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Experienced transient diplopia lasting less than 24 hours within the last 8 days
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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
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