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

Condition(s) studied

Study summary

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 or visual dysfunction 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.

Eligibility

Primary outcome measure(s)

• Diagnostic Performance of the 2022 International Criteria for Optic Neuritis — Index-test data within 3 months after symptom onset; reference-standard diagnosis up to 6 months after enrollment
  Sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios, with 95 percent confidence intervals, of the 2022 International Criteria for Optic Neuritis against Stage 2 full-information expert adjudication. Definite optic neuritis is index-positive and not optic neuritis is index-negative. Possible optic neuritis and indeterminate reference diagnoses are excluded from this conditional binary analysis and reported separately.

Trial sites (9)

More First Affiliated Hospital of Guangxi Medical University trials in China

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