Epidemiologic and Clinical Characteristics of Optic Neuritis in China

NCT ID: NCT04257734

Last Updated: 2021-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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Optic Neuritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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optic neuritis

Aquaporin 4 antibody seropositive optic neuritis patients, Myelin oligodendrocyte glycoprotein antibody seropositive optic neuritis patients, and double antibodies seronegative optic neuritis patients

observation

Intervention Type OTHER

different serum antibodies status

Interventions

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observation

different serum antibodies status

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Health Science Center

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wei Shihui

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shihui Wei, M.D

Role: STUDY_CHAIR

Ophthalmology, the Chinese PLA General Hospital

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Mo Yang, Ph.D

Role: CONTACT

+86-010-66938375

Mengying Lai, M.D

Role: CONTACT

+86-010-66938175

Facility Contacts

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Mo Yang, PhD

Role: primary

+86-183-1009-8349

Other Identifiers

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CONSG1

Identifier Type: -

Identifier Source: org_study_id

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