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

Study acronym: GX-ICON
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Minor Eligibility criteria revised Show 4 more changesShow less
    • Secondary endpoints: 6 to 7
    • Study description shortened, about 249 words
    • Site details revised at 2 of 9 sites
    • Publications: details revised at 2 of 2 entries
  2. Minor Secondary endpoints: 5 to 6v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 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.
Trial Details
NCT Number NCT07623252
Lead Sponsor First Affiliated Hospital of Guangxi Medical University
Conditions
(from sponsor)
Optic Neuritis, Optic Neuropathy, Visual Loss
Related terms Optic Nerve Diseases, Optic Neuritis, Vision Disorders
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov