NCT02886377

Brief Summary

To evaluate the optical coherence tomography (OCT), visual field (VF), Visual evoked po-tential(VEP) characteristics between neuromyelitis optica- related optic neuritis (NMOSD-ON) and multiple sclerosis- related ON (MS-ON) in a Chinese cohort.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Typical duration for all trials

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

Study Start

First participant enrolled

November 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 1, 2016

Status Verified

August 1, 2016

Enrollment Period

2.8 years

First QC Date

August 7, 2016

Last Update Submit

August 26, 2016

Conditions

Optic Neuritis

Outcome Measures

Primary Outcomes (1)

  • retinal nerve fiber layer thickness

    2013.11-2016.12

Secondary Outcomes (2)

  • visual field

    2013.11-2016.12

  • visual evoked potential

    2013.11-2016.12

Study Arms (3)

NMOSD-ON

NMOSD-ON included patients who met the established diagnostic criteria for NMO or NMOSD published by Wingerchuk et al,with AQP4 seropositive according to the results of the AQP4-Ab test.

Biological: blood test of anti-AQP4 antibody

MS-ON

MS-ON group patients included typical acute demyelinating ON with brain lesions fulfilling the revised McDonald criteria or clinical isolate syndrome (CIS), with AQP4 seronegative according to the results of the AQP4-Ab test.

Biological: blood test of anti-AQP4 antibody

Healthy controls

Age- and gender- matched healthy controls.

Biological: blood test of anti-AQP4 antibody

Interventions

blood test of anti-AQP4 antibodyBIOLOGICAL

Patients were sub-divided into an AQP4 seropositive group and an AQP4 seronegative group, according to blood test of the AQP4-Ab.

Healthy controlsMS-ONNMOSD-ON

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

250

You may qualify if:

  • Optic neuritis patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Optic Neuritis

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Officials

  • Hui Yang

    World Health Organization

    STUDY DIRECTOR

Central Study Contacts

Jian Zhang

CONTACT

020-87334687zoccrc@mail.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

August 7, 2016

First Posted

September 1, 2016

Study Start

November 1, 2013

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

September 1, 2016

Record last verified: 2016-08

Locations

CN(1)