Testing the 2022 Optic Neuritis Criteria in suspected cases of optic neuritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective observational study enrolls patients with acute or subacute visual loss where optic neuritis is a possible diagnosis. Researchers compare how well the 2022 International Criteria for Optic Neuritis performs on its own versus when an antibody-stratified adjunct is added, using routine clinical data collected within 3 months of symptom onset. Data are gathered from imaging, laboratory tests, and clinical findings, with follow-up information used to support reference-standard adjudication. Participants are followed during their current episode, and eligibility is limited to those not previously enrolled. The study does not modify standard care; decisions about testing and treatment are left to the treating clinicians. The goal is to determine diagnostic accuracy in a Chinese clinical setting where Aquaporin-4 and MOG antibodies are more common.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Individuals presenting with a new acute or subacute episode of visual loss or visual dysfunction in one or both eyes, for whom optic neuritis is considered a reasonable differential diagnosis by the treating clinical team at the initial clinical assessment and before final diagnostic adjudication.
2. Symptom onset of the current episode within 90 days before enrollment.

Exclusion Criteria:

1\. The participant has previously been enrolled in this study. Each participant may be enrolled only once.

A history of optic neuritis or recurrent optic neuropathy before the current episode is not an exclusion criterion.

Where it's running

• Guangxi Minzu Hospital
  Nanning, Guangxi, China Recruiting
• The Second Affiliated Hospital of Guangxi Medical University
  Nanning, Guangxi, China Recruiting
• The First Affiliated Hospital of Guangxi Medical University
  Nanning, Guangxi, China Recruiting
• Guangxi Jingliang Eye Hospital
  Nanning, Guangxi, China Recruiting
• Wuming Hospital of Guangxi Medical University
  Nanning, Guangxi, China Recruiting
• The Second People's Hospital of Qinzhou
  Qinzhou, Guangxi, China Recruiting

Study contacts

• Principal investigator: Yi Du, MD, PhD — First Affiliated Hospital of Guangxi Medical University
• Study coordinator: Yi Du, MD, PhD
• Email: duyinapoleon@gmail.com
• Phone: +86 771 5356507

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.