Epidemiologic and Clinical Characteristics of Optic Neuritis in China

• Conditions: Optic Neuritis

• Registration Number: NCT04257734
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-06
• Study Start: 2020-05-01
• Primary Completion: 2020-12-03
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-17
• Last Update Posted: 2021-01-20
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Acuity	At least 1 year from the attack to the final visit	Last visual acuity records in the hospital
Annual Relapse Rate	At least 1 year from the attack to the final visit	Calculated annual relapse rate of different subgroups in the cohort

Secondary Outcome Measures

Name	Time	Method
Clinical characteristics of optic neuritis	At least 1 year from the attack to the final visit	Visual acuity at nadir, pain, optic disc edema
Orbit or Brain MRI at the attack	At least 1 year from the attack to the final visit	Lesions of the optic nerve
Optical Coherence Tomography	At least 1 year from the attack to the final visit	RNFL, macular thickness and GCIPL at different time points
Epidemiologic characteristics of optic neuritis	At least 1 year from the attack to the final visit	Gender, age of first attack, location

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China