Epidemiologic and Clinical Characteristics of Optic Neuritis in China

Optic Neuritis Clinical Trial

Official title:

Epidemiologic and Clinical Characteristics of Optic Neuritis in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04257734
• Other study ID #: CONSG1
• Status: Recruiting
• Start date: May 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: January 2021
• Source: Chinese PLA General Hospital
• Contact: Mo Yang, Ph.D
• Phone: +86-010-66938375
• Email: doctoryangmo[@]icloud.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2021
• Est. primary completion date: December 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Neuritis
• Optic Neuritis

Intervention

Other:
• observation
different serum antibodies status

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Peking University Health Science Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	Last visual acuity records in the hospital	At least 1 year from the attack to the final visit
Primary	Annual Relapse Rate	Calculated annual relapse rate of different subgroups in the cohort	At least 1 year from the attack to the final visit
Secondary	Epidemiologic characteristics of optic neuritis	Gender, age of first attack, location	At least 1 year from the attack to the final visit
Secondary	Clinical characteristics of optic neuritis	Visual acuity at nadir, pain, optic disc edema	At least 1 year from the attack to the final visit
Secondary	Optical Coherence Tomography	RNFL, macular thickness and GCIPL at different time points	At least 1 year from the attack to the final visit
Secondary	Orbit or Brain MRI at the attack	Lesions of the optic nerve	At least 1 year from the attack to the final visit