Epidemiologic and Clinical Characteristics of Optic Neuritis in China

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.

Study Overview

• Status: Unknown
• Conditions: Optic Neuritis
• Intervention / Treatment: Other: observation

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Mo Yang, Ph.D; Phone Number: +86-010-66938375; Email: doctoryangmo@icloud.com
• Study Contact Backup: Name: Mengying Lai, M.D; Phone Number: +86-010-66938175; Email: 78313749@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100835
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Mo Yang, PhD; Phone Number: +86-183-1009-8349; Email: doctoryangmo@icloud.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Optic neuritis patients with complete medical records in multicenter from China.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
optic neuritis; Aquaporin 4 antibody seropositive optic neuritis patients, Myelin oligodendrocyte glycoprotein antibody seropositive optic neuritis patients, and double antibodies seronegative optic neuritis patients	Other: observation; different serum antibodies status

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Last visual acuity records in the hospital	At least 1 year from the attack to the final visit
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: Peking University Health Science Center
• Investigators: Study Chair: Shihui Wei, M.D, Ophthalmology, the Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2020
• Primary Completion (ACTUAL): December 3, 2020
• Study Completion (ANTICIPATED): June 30, 2021

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (ACTUAL): February 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 17, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: epidemiology; optic neuritis; clinical Characteristics
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Neuritis; Optic Neuritis
• Other Study ID Numbers: CONSG1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is a multi center study of optic neuritis, the individual participant data belongs to every single center. Now, we are applying for the approval. However, the details will not be available until all the centers approved.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No