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

Optic neuritis is an important cause of acute or subacute visual loss. In clinical practice, optic neuritis must often be distinguished from other optic neuropathies, retinal diseases, anterior-segment or ocular media disorders, non-organic visual loss, and other mimics. The 2022 International Criteria for Optic Neuritis were developed to standardize the diagnosis of optic neuritis, but their performance in Chinese clinical settings, where aquaporin-4 immunoglobulin G-positive and myelin oligodendrocyte glycoprotein immunoglobulin G-positive optic neuritis are relatively common, remains uncertain. This multicenter prospective observational study is enrolling patients with acute or subacute visual loss in whom optic neuritis is included in the differential diagnosis. The study is designed to evaluate the diagnostic performance of the 2022 International Criteria for Optic Neuritis alone and with an antibody-stratified adjunct. The index classifications will be compared with an expert-adjudicated reference-standard diagnosis. No experimental treatment is assigned by the study. All diagnostic tests and treatments are determined by the treating clinicians according to routine clinical care. Study data are collected using a structured protocol-defined case report form.

NCT Number	NCT07623252
Lead Sponsor	First Affiliated Hospital of Guangxi Medical University
Conditions	Optic Neuritis, Optic Neuropathy, Visual Loss
Enrollment	500 participants
Start Date	2025-01-06
Primary Completion	2027-12 (estimated)
Study Completion	2028-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-15