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Epidemiologic and Clinical Characteristics of Optic Neuritis in China

Epidemiologic and Clinical Characteristics of Optic Neuritis in China

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04257734
Enrollment
1000
Registered
2020-02-06
Start date
2020-05-01
Completion date
2021-06-30
Last updated
2021-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Optic Neuritis

Keywords

optic neuritis, clinical Characteristics, epidemiology

Brief summary

This will be a hospital-based retrospective multi-center study on epidemiologic and clinical characteristics of optic neuritis among Chinese. The investigation will cover about 29 provinces or municipalities all around China.

Detailed description

This national investigation will be conducted to describe the epidemiology and clinical characteristics of optic neuritis in China. All the patients will be divided into 3 groups according to the serum demyelinating antibodies (Aquaporin-4 antibody seropositive group, Myelin oligodendrocyte glycoprotein antibody seropositive group and double seronegative group). The investigator will analyze the differences among the three groups. Primary outcomes: * To dig out the different visual acuity (VA, LogMAR) prognosis among the three groups; * To calculate the annual relapse rate (ARR) differences among the three groups (relapse times in all the follow-up time in each group/ follow-up time (years) in all in each group). Secondary outcomes: * Other epidemiological and clinical characteristics of optic neuritis patients will be analyzed among the three groups; * Orbital or Brain MRI is required in this study, which could avoid the misdiagnosis. We will collect and analyze these MRI data too (including the optic nerve lesions in T2 weight images and T1 enhanced MRI); * Results of optical coherence tomography (OCT) (including peripapillary retinal nerve fiber layer, macular thickness ,and ganglion cell and inner plexiform layer complex) at different time point are also needed in this study. However, OCT is not necessarily required; * Visual fields at different time points are also encouraged to provide if they are available.

Interventions

OTHERobservation

different serum antibodies status

Sponsors

Peking University Health Science Center
CollaboratorOTHER
Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Clinical diagnosis of optic neuritis 2. The patients' medical records were complete

Exclusion criteria

1. Patients with unclear diagnosis of optic neuritis 2. Incomplete medical records

Design outcomes

Primary

MeasureTime frameDescription
Visual AcuityAt least 1 year from the attack to the final visitLast visual acuity records in the hospital
Annual Relapse RateAt least 1 year from the attack to the final visitCalculated annual relapse rate of different subgroups in the cohort

Secondary

MeasureTime frameDescription
Epidemiologic characteristics of optic neuritisAt least 1 year from the attack to the final visitGender, age of first attack, location
Clinical characteristics of optic neuritisAt least 1 year from the attack to the final visitVisual acuity at nadir, pain, optic disc edema
Optical Coherence TomographyAt least 1 year from the attack to the final visitRNFL, macular thickness and GCIPL at different time points
Orbit or Brain MRI at the attackAt least 1 year from the attack to the final visitLesions of the optic nerve

Countries

China

Contacts

Primary ContactMo Yang, Ph.D
doctoryangmo@icloud.com+86-010-66938375
Backup ContactMengying Lai, M.D
78313749@qq.com+86-010-66938175

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026