Optic Neuritis Differential Diagnosis Study (ONDDS)

Status unknownNot a drug-phase studyMS (type not specified)NCT03370965

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Neuro-ophtalmology examination

What it measured

Main measures

  • Final diagnosis using MS (McDonald, 2010) - Spatial dissemination

    12 months

    MRI lesions
  • Final diagnosis using MS (McDonald, 2010) - Time dissemination

    12 months

    MRI lesions
  • NMO diagnosis criteria (Wingerchuk, 2015) - Diagnosis of NMO-SD with positive anti-AQP4 Antibody

    12 months

  • NMO diagnosis criteria (Wingerchuk, 2015) - Diagnosis of NMO-SD with anti-AQP4 negative antibody

    12 months

    MRI lesions

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

1. Patient aged 18 years or older at time of inclusion. 2. Table of unilateral or bilateral optic neuritis defined as follows (clinical diagnosis): 1. Visual sharpness (acuity and / or visual field) experienced acutely or subacutely (\<1 month) unilateral or bilateral, not corrected by optical correction. 2. Absence of ophthalmologic lesion which may explain the visual loss. 3. Examination of the normal fundus or showing a pallor or papular edema. 4. Presence of relative pupillary deficit relative if unilateral attack. 3. Patient (s) affiliated to a social security scheme (beneficiary or beneficiary). 4. Patient who has given free and written consent.

Exclusion criteria

1. Patients known to have an inflammatory disease of the central nervous system (MS, NMO, EMAD). 2. Known history of inflammatory pathology (lupus or sarcoidosis) or infectious pathology (syphilis, HIV) that may give rise to optical neuropathy. 3. Table suggestive of Leber's hereditary optic neuropathy (genetically confirmed). 4. Treatment in progress known to give optical neuropathies. 5. Consumption of toxic known to give optical neuropathies. 6. Drinking more than 3 alcohol drinks per day for men and 2 alcohol drinks per day for women over a period of more than 15 years. 7. Arguments for non-arteritic ischemic optic neuropathy defined by all of the following criteria: 1. Absence of pain in eye movements. 2. Altitudinal deficit of the visual field. 3. Choroidal ischemia with fluorescein angiography. 4. Presence of cardiovascular risk factors. 5. Absence of neurological signs related to inflammatory disease of the central nervous system. 8. Arguments for arterial ischemic optic neuropathy defined by all of the following criteria: 1. Absence of pain in eye movements. 2. Altitudinal deficit of the visual field. 3. Choroidal ischemia with fluorescein angiography. 4. Presence of symptoms suggestive of Horton's disease. 5. Absence of neurological signs related to inflammatory disease of the central nervous system. 9. Pregnant and lactating patients.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Background: Optic neuritis is a frequent cause of vision loss encountered by ophthalmologists in the Caribbean. The diagnosis is made on clinical grounds. Optic neuritis can occur either in an isolated manner or, most often, as the first symptom of multiple sclerosis (MS) or neuromyelitisoptica (NMO). These 2 demyelinating disorders differ by many means, including treatment and prognosis. MS can cause severe long-term disability while NMO is a short-term sight- and life-threatening condition causing potential relapses, which may require plasma exchanges. Furthermore, disease-modifying therapies used in NMO are different from those used in MS, which can worsen the natural history of NMO. Early differential diagnosis of these diseases is thus crucial for preventing severe visual loss and disability.

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History

    1. Started

      Jun 2019

    2. Main results due

      Jun 2024

    3. Finished

      Jun 2025

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