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

NCT07623252 | Recruiting

• 1 other identifier: GX-ICON
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 9

Brief 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 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.

Conditions

Optic Neuritis; Visual Loss; Optic Neuropathy

Keywords

2022 International Criteria for Optic Neuritis; Diagnostic accuracy; Antibody-stratified adjunct; Aquaporin-4 immunoglobulin G; Myelin oligodendrocyte glycoprotein immunoglobulin G

Outcome Measures

Primary Outcomes (1)

• Diagnostic Performance of the 2022 International Criteria for Optic Neuritis

  Sensitivity, specificity, predictive values, likelihood ratios, and 95 percent confidence intervals will be assessed against the expert-adjudicated reference standard. Definite optic neuritis will be index-test positive and not optic neuritis will be index-test negative. Possible optic neuritis will be treated as an indeterminate index-test category and reported separately. Indeterminate reference-standard diagnoses will be excluded. Index-test classification will use eligible baseline and paraclinical data obtained within 3 months after symptom onset; later follow-up data will not revise the index-test classification.

  Index-test data within 3 months after symptom onset; reference-standard diagnosis up to 6 months after enrollment

Secondary Outcomes (5)

• Diagnostic Yield of Definite Optic Neuritis Classification

  Index-test data within 3 months after symptom onset; reference-standard diagnosis up to 6 months after enrollment

• Diagnostic Performance of the Low-Threshold 2022 Criteria Definition

  Index-test data within 3 months after symptom onset; reference-standard diagnosis up to 6 months after enrollment

• Diagnostic Performance of the 2022 International Criteria for Optic Neuritis With the Antibody-Stratified Adjunct

  Index-test data within 3 months after symptom onset; reference-standard diagnosis up to 6 months after enrollment

• Proportion of Indeterminate Reference-Standard Diagnoses

  Up to 6 Months After Enrollment

• Distribution of 2022 International Criteria for Optic Neuritis Classifications

  Baseline and diagnostic-window data for the current episode, within 3 months after symptom onset

Study Arms (1)

Suspected Optic Neuritis Differential-Diagnosis Cohort

Individuals with acute or subacute visual loss or optic nerve-related visual dysfunction in whom optic neuritis is included in the differential diagnosis at initial clinical assessment. Participants undergo routine clinical evaluation, and study data are collected using a structured protocol-defined case report form. No treatment is assigned by the study. The 2022 International Criteria for Optic Neuritis will be evaluated alone and with the antibody-stratified adjunct as diagnostic index-test approaches.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with a new acute or subacute episode of visual loss or optic nerve-related visual dysfunction in one or both eyes, for whom optic neuritis is included in the initial differential diagnosis at participating clinical centers. Each participant contributes only one clinical episode to the primary diagnostic accuracy cohort.

You may qualify if:

• Individuals presenting with a new acute or subacute episode of visual loss or optic nerve-related 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.
• Symptom onset of the current episode within 90 days before enrollment.

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University: lead

Study Sites (9)

Guangxi Minzu Hospital

Nanning, Guangxi, 530001, China

RECRUITING

The Second Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530005, China

RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

Guangxi Jingliang Eye Hospital

Nanning, Guangxi, 530022, China

RECRUITING

Wuming Hospital of Guangxi Medical University

Nanning, Guangxi, 530199, China

RECRUITING

The Second People's Hospital of Qinzhou

Qinzhou, Guangxi, 535000, China

RECRUITING

Wuzhou Gongren Hospital

Wuzhou, Guangxi, 543099, China

RECRUITING

The First People's Hospital of Yulin

Yulin, Guangxi, 537099, China

RECRUITING

Lixiang Eye Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

Related Publications (2)

• Liang Y, Yang J, Luo W, Wei S, Wang K, Song R, Fu R, Zhao Y, Bai Y, Du Y. Diagnostic yield of the 2022 optic neuritis criteria and an antibody-stratified adjunct in an antibody-predominant Chinese clinical sample. Mult Scler Relat Disord. 2026 Apr 25;111:107212. doi: 10.1016/j.msard.2026.107212. Online ahead of print.

  PMID: 42066614 BACKGROUND

• Petzold A, Fraser CL, Abegg M, Alroughani R, Alshowaeir D, Alvarenga R, Andris C, Asgari N, Barnett Y, Battistella R, Behbehani R, Berger T, Bikbov MM, Biotti D, Biousse V, Boschi A, Brazdil M, Brezhnev A, Calabresi PA, Cordonnier M, Costello F, Cruz FM, Cunha LP, Daoudi S, Deschamps R, de Seze J, Diem R, Etemadifar M, Flores-Rivera J, Fonseca P, Frederiksen J, Frohman E, Frohman T, Tilikete CF, Fujihara K, Galvez A, Gouider R, Gracia F, Grigoriadis N, Guajardo JM, Habek M, Hawlina M, Martinez-Lapiscina EH, Hooker J, Hor JY, Howlett W, Huang-Link Y, Idrissova Z, Illes Z, Jancic J, Jindahra P, Karussis D, Kerty E, Kim HJ, Lagreze W, Leocani L, Levin N, Liskova P, Liu Y, Maiga Y, Marignier R, McGuigan C, Meira D, Merle H, Monteiro MLR, Moodley A, Moura F, Munoz S, Mustafa S, Nakashima I, Noval S, Oehninger C, Ogun O, Omoti A, Pandit L, Paul F, Rebolleda G, Reddel S, Rejdak K, Rejdak R, Rodriguez-Morales AJ, Rougier MB, Sa MJ, Sanchez-Dalmau B, Saylor D, Shatriah I, Siva A, Stiebel-Kalish H, Szatmary G, Ta L, Tenembaum S, Tran H, Trufanov Y, van Pesch V, Wang AG, Wattjes MP, Willoughby E, Zakaria M, Zvornicanin J, Balcer L, Plant GT. Diagnosis and classification of optic neuritis. Lancet Neurol. 2022 Dec;21(12):1120-1134. doi: 10.1016/S1474-4422(22)00200-9. Epub 2022 Sep 27.

  PMID: 36179757 BACKGROUND

MeSH Terms

Conditions

Optic Neuritis; Optic Nerve Diseases; Vision Disorders

Condition Hierarchy (Ancestors)

Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yi Du, MD, PhD

  First Affiliated Hospital of Guangxi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Du, MD, PhD

CONTACT

+86 771 5356507; duyinapoleon@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Department of Ophthalmology

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: June 3, 2026
• Study Start: January 6, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (9)