Evaluating the 2022 International Criteria for Diagnosing Optic Neuritis and Antibody Tests in Patients with Recent Visual Loss in China

What this Trial Is About

Researchers are conducting a multicenter prospective observational study in China to evaluate how well the 2022 International Criteria for Optic Neuritis diagnose optic neuritis in patients who experience acute or subacute visual loss. This study focuses on patients for whom optic neuritis is part of the initial diagnosis consideration, especially in settings where aquaporin-4 and myelin oligodendrocyte glycoprotein immunoglobulin G-positive optic neuritis are common. The study compares these criteria alone and with an antibody-stratified adjunct against an expert panels final diagnosis. Participants receive routine clinical care without study-assigned treatments. Data collection includes detailed baseline clinical assessments such as symptom details, eye examinations, and visual function tests. Additionally, routine paraclinical tests like visual fields, optical coherence tomography, MRI, and antibody testing are collected when performed by clinicians. Follow-up visits up to six months after enrollment gather information on clinical course, further testing, and treatment responses to support the expert adjudication. Throughout the study, participants contribute clinical and laboratory data via structured electronic forms. The research team measures the diagnostic accuracy of the 2022 criteria by comparing initial classifications to expert diagnoses made with up to six months of clinical follow-up. Secondary analyses assess diagnostic yields and the role of the antibody-stratified adjunct. No experimental treatments are given, and all care decisions are made by the treating clinicians as part of routine practice.

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