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

2026년 5월 29일 업데이트: 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.

연구 개요

상태

모병

정황

상세 설명

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.

연구 유형

관찰

등록 (추정된)

500

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Diagnostic Performance of the 2022 International Criteria for Optic Neuritis
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Diagnostic Yield of Definite Optic Neuritis Classification
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

First Affiliated Hospital of Guangxi Medical University

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 1월 6일

기본 완료 (추정된)

2027년 12월 1일

연구 완료 (추정된)

2028년 1월 1일

연구 등록 날짜

최초 제출

2026년 5월 11일

QC 기준을 충족하는 최초 제출

2026년 5월 29일

처음 게시됨 (실제)

2026년 6월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 29일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • GX-ICON

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다