NCT04257734

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

7 months

First QC Date

February 4, 2020

Last Update Submit

January 17, 2021

Conditions

Keywords

optic neuritisclinical Characteristicsepidemiology

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Epidemiologic characteristics of optic neuritis

    At least 1 year from the attack to the final visit

  • Clinical characteristics of optic neuritis

    At least 1 year from the attack to the final visit

  • Optical Coherence Tomography

    At least 1 year from the attack to the final visit

  • Orbit or Brain MRI at the attack

    At least 1 year from the attack to the final visit

Study Arms (1)

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

Interventions

different serum antibodies status

optic neuritis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Clinical diagnosis of optic neuritis
  • The patients' medical records were complete

You may not qualify if:

  • Patients with unclear diagnosis of optic neuritis
  • Incomplete medical records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100835, China

RECRUITING

MeSH Terms

Conditions

Optic Neuritis

Interventions

Observation

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Shihui Wei, M.D

    Ophthalmology, the Chinese PLA General Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 6, 2020

Study Start

May 1, 2020

Primary Completion

December 3, 2020

Study Completion

June 30, 2021

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations