NCT07623252 Prospective Evaluation of the 2022 Optic Neuritis Criteria When Optic Neuritis Is Suspected
| NCT ID | NCT07623252 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Guangxi Medical University |
| Condition | Optic Neuritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-01-06 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2025-01-06 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Yi Du, MD, PhD
PRINCIPAL INVESTIGATOR
First Affiliated Hospital of Guangxi Medical University
Frequently Asked Questions
Who can join the NCT07623252 clinical trial?
This trial is open to participants of all sexes, studying Optic Neuritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07623252 currently recruiting?
Yes, NCT07623252 is actively recruiting participants. Contact the research team at duyinapoleon@gmail.com for enrollment information.
Where is the NCT07623252 trial being conducted?
This trial is being conducted at Nanning, China, Nanning, China, Nanning, China, Nanning, China and 5 additional locations.
Who is sponsoring the NCT07623252 clinical trial?
NCT07623252 is sponsored by First Affiliated Hospital of Guangxi Medical University. The principal investigator is Yi Du, MD, PhD at First Affiliated Hospital of Guangxi Medical University. The trial plans to enroll 500 participants.