Prospective Evaluation of the 2022 Optic Neuritis Criteria When Optic Neuritis Is Suspected
Key facts
- Who runs it
- First Affiliated Hospital of Guangxi Medical University
- Where
- China9 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 500 people, planned
- Started
- 6 Jan 2025
- Expected to end
- Jan 2028
- Type of study
- Observational
- Record updated
- 25 September 2026
Who can take part
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Individuals presenting with a new acute or subacute episode of visual loss or 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
Who cannot take part
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The group in the trial
- Suspected Optic Neuritis Differential-Diagnosis Cohort
Individuals with acute or subacute visual loss or visual dysfunction in whom optic neuritis is included in the differential diagnosis at initial clinical assessment. Participants undergo routine clinical evaluation, with study data collected using a structured case report form. The 2022 International Criteria for Optic Neuritis are evaluated alone and with the antibody-stratified adjunct. No treatment is assigned by the study.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Record updated
- 25 September 2026