Clinical trial NCT04257734: Epidemiologic and Clinical Characteristics of Optic Neuritis in China
Official title: Epidemiologic and Clinical Characteristics of Optic Neuritis in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Optic Neuritis
Keywords: optic neuritis
clinical Characteristics
epidemiology
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Health Science Center
First posted: 2020-02-06
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Optic neuritis patients with complete medical records in multicenter from China.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Acuity
timeFrame: At least 1 year from the attack to the final visit
measure: Annual Relapse Rate
timeFrame: At least 1 year from the attack to the final visit
Secondary outcomes:
measure: Epidemiologic characteristics of optic neuritis
timeFrame: At least 1 year from the attack to the final visit
measure: Clinical characteristics of optic neuritis
timeFrame: At least 1 year from the attack to the final visit
measure: Optical Coherence Tomography
timeFrame: At least 1 year from the attack to the final visit
measure: Orbit or Brain MRI at the attack
timeFrame: At least 1 year from the attack to the final visit
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Ophthalmology, the Chinese PLA General Hospital
name: Shihui Wei, M.D
role: STUDY_CHAIR
References: