A Multicenter Prospective Diagnostic Accuracy Study of the 2022 International Criteria for Optic Neuritis and an Antibody-Stratified Adjunct in Acute or Subacute Visual Loss When Optic Neuritis Is Suspected in China

What this Trial Is About

Researchers are evaluating the 2022 International Criteria for Optic Neuritis to see how well they diagnose optic neuritis in patients with acute or subacute visual loss in China. This observational study focuses on cases where optic neuritis is suspected and aims to assess the criteria alone and combined with antibody testing, especially for types of optic neuritis that are common in this population. The accuracy of these criteria will be compared to expert diagnoses using detailed clinical information. Participants undergo routine clinical evaluations without any experimental treatments assigned by the study. Data are collected using a structured electronic case report form capturing symptoms, eye examinations, and relevant imaging and laboratory tests such as MRI and antibody tests when clinically indicated. Follow-up assessments, including optical coherence tomography, may occur up to 6 months after enrollment to support diagnosis and monitor clinical progress. Throughout the study, clinical, imaging, and laboratory data collected during usual care are used to classify participants as having definite, possible, or no optic neuritis. Expert adjudicators independently review all available information to establish a reference diagnosis. The study measures diagnostic accuracy, including sensitivity and specificity, based on data collected within 3 months of symptom onset and follow-up up to 6 months. No treatments are dictated by the study, and all medical care decisions remain with the treating clinicians.

Prospective Evaluation of the 2022 Optic Neuritis Criteria When Optic Neuritis Is Suspected