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Prospective Evaluation of the 2022 Optic Neuritis Criteria When Optic Neuritis Is Suspected (GX-ICON)

29. Mai 2026 aktualisiert von: Yi Du, First Affiliated Hospital of Guangxi Medical University

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

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Detaillierte Beschreibung

This is a multicenter prospective observational diagnostic accuracy study conducted in China. Structured prospective electronic case report form-based data collection for the primary diagnostic accuracy cohort began on January 6, 2025. The study population includes 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.

The main objective is to evaluate the diagnostic performance of the 2022 International Criteria for Optic Neuritis in a real-world Chinese clinical setting. The study is also designed to evaluate the 2022 International Criteria for Optic Neuritis with a prespecified antibody-stratified adjunct strategy designed for settings where aquaporin-4 immunoglobulin G-positive optic neuritis and myelin oligodendrocyte glycoprotein immunoglobulin G-positive optic neuritis are relatively common and antibody testing is clinically available.

Baseline clinical data are collected prospectively using a structured electronic case report form. The form captures demographic information, symptom onset, laterality, pain with eye movement, visual acuity, protocol-defined color vision assessment, relative afferent pupillary defect assessment, and other predefined clinical variables.

Paraclinical data are collected when obtained as part of routine clinical care. These data may include visual field testing, optical coherence tomography, orbital or optic nerve MRI, serum aquaporin-4 immunoglobulin G, serum myelin oligodendrocyte glycoprotein immunoglobulin G, and other laboratory or imaging results. Optical coherence tomography is encouraged for objective structural characterization when clinically feasible, but it is not mandated by study participation. Follow-up optical coherence tomography at 3 to 6 months is encouraged when clinically feasible. Available follow-up optical coherence tomography data will be summarized descriptively. Exploratory optical coherence tomography-available analyses may be performed if data are sufficient; these analyses are not required for the primary diagnostic accuracy analysis. MRI and antibody testing are performed when considered clinically appropriate by the treating clinical team.

The 2022 International Criteria for Optic Neuritis serve as the index test. Index-test classifications will be assigned using baseline clinical data and paraclinical data eligible for application of the 2022 International Criteria for Optic Neuritis that were obtained within 3 months after symptom onset for the current clinical episode, based on the timing of the examination or sample collection. Follow-up information obtained after this diagnostic window will not be used to revise the index-test classification. Participants will be classified as definite optic neuritis, possible optic neuritis, or not optic neuritis according to prespecified rules. A prespecified antibody-stratified adjunct strategy, based on our published adjunct framework, will then be applied in combination with the 2022 International Criteria for Optic Neuritis, rather than as a standalone diagnostic test. This adjunct strategy incorporates aquaporin-4 immunoglobulin G seropositivity and clear-positive myelin oligodendrocyte glycoprotein immunoglobulin G results together with objective optic nerve evidence. The detailed operational rules are specified in the study protocol and are based on the cited published framework.

Participants are followed for up to 6 months after enrollment whenever feasible. Follow-up information includes available information on subsequent clinical course, repeat ophthalmic assessments, additional imaging or laboratory results, treatment response, and alternative diagnoses made during routine clinical care. This follow-up information will be used to support the expert-adjudicated reference-standard diagnosis. Participants for whom the reference-standard adjudication committee cannot assign a diagnosis of optic neuritis or non-optic neuritis because of insufficient clinical, imaging, laboratory, or follow-up information will be classified as indeterminate according to prespecified adjudication rules. Indeterminate reference-standard cases will be summarized separately and excluded from the primary binary diagnostic accuracy analysis.

Follow-up information beyond the prespecified index-test diagnostic window will be used for reference-standard adjudication only.

The reference-standard diagnosis will be determined by an expert adjudication panel. Two expert adjudicators will independently review the structured baseline clinical form and all available ophthalmic, imaging, laboratory, treatment, and follow-up information according to a prespecified adjudication process. The adjudicators will be masked to the 2022 International Criteria for Optic Neuritis classification and the antibody-stratified adjunct classification. They will not be masked to the source clinical, ophthalmic, imaging, laboratory, treatment, or follow-up information required for reference-standard adjudication. Disagreements will be resolved by a third expert adjudicator. Participants will be classified as optic neuritis, non-optic neuritis, or indeterminate. Cases with an indeterminate reference-standard diagnosis will be reported separately and will not be included in the primary diagnostic accuracy analysis. The initial agreement between the two expert adjudicators will be summarized using the percentage agreement and Cohen's kappa for the three-category reference-standard classification of optic neuritis, non-optic neuritis, or indeterminate.

The primary diagnostic accuracy analysis will compare the index-test classification with the expert-adjudicated reference-standard diagnosis. In the main analysis, definite optic neuritis will be classified as index-test positive and not optic neuritis will be classified as index-test negative. Possible optic neuritis will be treated as an indeterminate index-test category, excluded from the main binary diagnostic accuracy analysis, and reported separately. Key secondary analyses will evaluate the diagnostic yield of definite optic neuritis, the distribution of possible optic neuritis, the performance of a low-threshold definition that classifies definite or possible optic neuritis as index-test positive, and the performance of the 2022 International Criteria for Optic Neuritis with the antibody-stratified adjunct. Diagnostic measures will include sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratios, and 95 percent confidence intervals, as appropriate.

The study is observational. The investigators do not assign experimental treatment or alter routine clinical management. Treatment decisions, including corticosteroids, plasma exchange, immunosuppressive therapy, biologic therapy, or treatment for non-inflammatory alternative diagnoses, are made by the treating clinical team as part of routine clinical care and are not dictated by the study protocol.

At the time this record was initially submitted for public registration, recruitment was ongoing, and database lock, formal reference-standard adjudication, final index-test classification, and the primary diagnostic accuracy analysis had not occurred.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

500

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Rekrutierung
        • The First Affiliated Hospital of Guangxi Medical University
        • Kontakt:
      • Nanning, Guangxi, China, 530005
        • Rekrutierung
        • The Second Affiliated Hospital of Guangxi Medical University
        • Kontakt:
      • Nanning, Guangxi, China, 530001
        • Rekrutierung
        • Guangxi Minzu Hospital
        • Kontakt:
      • Nanning, Guangxi, China, 530022
        • Rekrutierung
        • Guangxi Jingliang Eye Hospital
        • Kontakt:
          • Mukun Zhao
          • Telefonnummer: +86 771 7980630
      • Nanning, Guangxi, China, 530199
        • Rekrutierung
        • Wuming Hospital of Guangxi Medical University
        • Kontakt:
          • Xiaoyuan Ma
          • Telefonnummer: +86 771 6226473
        • Kontakt:
          • Yihua Huang
      • Qinzhou, Guangxi, China, 535000
        • Rekrutierung
        • The Second People's Hospital of Qinzhou
        • Kontakt:
          • Fangfang Zhang
          • Telefonnummer: +86 777 3682222
      • Wuzhou, Guangxi, China, 543099
        • Rekrutierung
        • Wuzhou Gongren Hospital
        • Kontakt:
          • Jun Yang
          • Telefonnummer: +86 774 2036883
      • Yulin, Guangxi, China, 537099
        • Rekrutierung
        • The First People's Hospital of Yulin
        • Kontakt:
          • Na Li
          • Telefonnummer: +86 775 2683288
        • Kontakt:
          • Qingjuan Zhao
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • Rekrutierung
        • Lixiang Eye Hospital of Soochow University
        • Kontakt:
          • Yinbin Tang
          • Telefonnummer: +86 512 69359692

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

Inclusion Criteria:

  1. 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.
  2. Symptom onset of the current episode within 90 days before enrollment.

Exclusion Criteria:

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

A history of optic neuritis or recurrent optic neuropathy before the current episode is not an exclusion criterion.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Diagnostic Performance of the 2022 International Criteria for Optic Neuritis
Zeitfenster: Index-test data within 3 months after symptom onset; reference-standard diagnosis up to 6 months after enrollment
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Diagnostic Yield of Definite Optic Neuritis Classification
Zeitfenster: Index-test data within 3 months after symptom onset; reference-standard diagnosis up to 6 months after enrollment
Proportion of participants with expert-adjudicated optic neuritis who are classified as definite optic neuritis by 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
Diagnostic Performance of the Low-Threshold 2022 Criteria Definition
Zeitfenster: Index-test data within 3 months after symptom onset; reference-standard diagnosis up to 6 months after enrollment
Sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratios, and 95 percent confidence intervals when definite optic neuritis or possible optic neuritis is classified as index-test positive and not optic neuritis is classified as index-test negative.
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
Zeitfenster: Index-test data within 3 months after symptom onset; reference-standard diagnosis up to 6 months after enrollment
The antibody-stratified adjunct will be applied in combination with the 2022 International Criteria for Optic Neuritis, rather than as a standalone diagnostic test. Diagnostic performance of the combined criteria-plus-adjunct classification will be assessed against the expert-adjudicated reference standard. Participants with an indeterminate reference-standard diagnosis will be excluded from this binary diagnostic accuracy analysis.
Index-test data within 3 months after symptom onset; reference-standard diagnosis up to 6 months after enrollment
Proportion of Indeterminate Reference-Standard Diagnoses
Zeitfenster: Up to 6 Months After Enrollment
Proportion of participants for whom the expert adjudication panel classifies the reference-standard diagnosis as indeterminate.
Up to 6 Months After Enrollment
Distribution of 2022 International Criteria for Optic Neuritis Classifications
Zeitfenster: Baseline and diagnostic-window data for the current episode, within 3 months after symptom onset
Proportion of participants classified as definite optic neuritis, possible optic neuritis, or not optic neuritis by the 2022 International Criteria for Optic Neuritis.
Baseline and diagnostic-window data for the current episode, within 3 months after symptom onset

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

First Affiliated Hospital of Guangxi Medical University

Ermittler

  • Hauptermittler: Yi Du, MD, PhD, First Affiliated Hospital of Guangxi Medical University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

6. Januar 2025

Primärer Abschluss (Geschätzt)

1. Dezember 2027

Studienabschluss (Geschätzt)

1. Januar 2028

Studienanmeldedaten

Zuerst eingereicht

11. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Mai 2026

Zuerst gepostet (Tatsächlich)

3. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • GX-ICON

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified participant-level data and a data dictionary will be made available to qualified researchers upon reasonable request after publication of the main diagnostic accuracy results, subject to ethics approval, institutional approval, and execution of a data use agreement.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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