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

2026年5月29日 更新者：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.

調査の概要

状態

募集

条件

詳細な説明

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.

研究の種類

観察的

入学 (推定)

500

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Diagnostic Performance of the 2022 International Criteria for Optic Neuritis
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Diagnostic Yield of Definite Optic Neuritis Classification
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

First Affiliated Hospital of Guangxi Medical University

捜査官

  • 主任研究者：Yi Du, MD, PhD、First Affiliated Hospital of Guangxi Medical University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年1月6日

一次修了 (推定)

2027年12月1日

研究の完了 (推定)

2028年1月1日

試験登録日

最初に提出

2026年5月11日

QC基準を満たした最初の提出物

2026年5月29日

最初の投稿 (実際)

2026年6月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月3日

QC基準を満たした最後の更新が送信されました

2026年5月29日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • GX-ICON

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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.

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いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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