The Correlation Between AQP-4 Ab and the Visual Function of Patients With Demyelinating ON at Onset

X

Xiujuan Zhao

Status

Unknown

Conditions

Optic Neuritis

Treatments

Biological: blood test of anti-AQP4 antibody

Study type

Observational

Funder types

Other

Identifiers

NCT02886377
2014meky049

Details and patient eligibility

About

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.

Full description

Patients were sub-divided into an AQP4 seropositive group and an AQP4 seronegative group, according to the results of the AQP4-Ab test. All patients with complete medical histories underwent routine neurological examinations, brain MRIs, and ophthalmological examinations, including best corrected visual acuity (BCVA), intraocular pressure, slit lamp and fundus examination, VF and VEP, laboratory testing, including blood routine, HIV HBV HCV Syphilis, mitochondrial DNA sequencing, and a profile of autoantibodies, including antinuclear antibody (ANA), extractable nuclear antigen antibodies (SSA/SSB), rheumatoid factor (RF), anticardiolipin antibodies (ACA), and antithyroglobulin antibody.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Optic neuritis patients

Exclusion criteria

The presence of significant refractive errors (3D of spherical equivalent refraction or 2D of astigmatism), intraocular pressure of 21 mmHg or higher, systemic conditions that could affect the visual system, and a history of ocular trauma or concomitant ocular diseases, including a history of media opacification, ocular pathologies affecting the cornea, lens, retinal disease, glaucoma, or laser therapy. All patients in the study groups had an episode of ON more than six months before the study inclusion time point.

Trial design

300 participants in 3 patient groups

NMOSD-ON
Description:
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.
Treatment:
Biological: blood test of anti-AQP4 antibody
MS-ON
Description:
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.
Treatment:
Biological: blood test of anti-AQP4 antibody
Healthy controls
Description:
Age- and gender- matched healthy controls.
Treatment:
Biological: blood test of anti-AQP4 antibody

Trial contacts and locations

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Central trial contact

Jian Zhang

Data sourced from clinicaltrials.gov

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