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

Study Overview
=================
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.

Detailed 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.

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

Conditions
-----------------
Optic Neuritis

Intervention / Treatment
-----------------
* Biological: blood test of anti-AQP4 antibody


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NMOSD-ON<br>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<br>* Patients were sub-divided into an AQP4 seropositive group and an AQP4 seronegative group, according to blood test of the AQP4-Ab.<br>|
| MS-ON<br>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<br>* Patients were sub-divided into an AQP4 seropositive group and an AQP4 seronegative group, according to blood test of the AQP4-Ab.<br>|
| Healthy controls<br>Age- and gender- matched healthy controls. | Biological: blood test of anti-AQP4 antibody<br>* Patients were sub-divided into an AQP4 seropositive group and an AQP4 seronegative group, according to blood test of the AQP4-Ab.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retinal nerve fiber layer thickness |  | 2013.11-2016.12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual field |  | 2013.11-2016.12 | 
| visual evoked potential |  | 2013.11-2016.12 |