Differentiating causes of optic neuritis

Optic Neuritis Differential Diagnosis Study (ONDDS)

This study is trying to find out how to tell if optic neuritis is a sign of a serious condition like neuromyelitis optica in adults, to help catch it early and prevent vision loss.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital Center of Martinique (Academic / other)
• Locations: 1 site (Fort-de-France)
• Trial ID: NCT03370965 on ClinicalTrials.gov

What this trial studies

This study aims to identify early predictive factors for neuromyelitis optica (NMO) in patients presenting with optic neuritis, a condition that can signal serious underlying diseases like multiple sclerosis (MS) or NMO. Conducted across multiple centers in the Caribbean, the study will include patients aged 18 and older with no prior history of demyelinating disorders. Participants will undergo comprehensive neuro-ophthalmic examinations to assess their condition. The goal is to improve early diagnosis and treatment strategies to prevent severe visual loss and disability.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older presenting with unilateral or bilateral optic neuritis without a prior history of demyelinating diseases.

Not a fit: Patients with known inflammatory diseases of the central nervous system, such as MS or NMO, will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate and timely diagnoses of optic neuritis, potentially improving treatment outcomes for patients.

How similar studies have performed: While the approach of early differential diagnosis is critical, similar studies have shown varying degrees of success in improving outcomes for optic neuritis and related conditions.

Eligibility 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.

Where this trial is running

Fort-de-France

• CHU of Martinique — Fort-de-France, France (Recruiting)

Study contacts

• Principal investigator: Philippe CABRE, PhD — Centre Hospitalier Universitaire de Martinique
• Study coordinator: Philippe CABRE, PhD

Conditions Optic Neuritis; Neuromyelitis Optica; Multiple Sclerosis; optic neuritis; neuromyelitis optica; multiple sclerosis; emergent treatment of optic neuritis; optic neuritis disease modifying therapy