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

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.

Study Overview

• Status: Unknown
• Conditions: Optic Neuritis
• Intervention / Treatment: Biological: blood test of anti-AQP4 antibody

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Jian Zhang; Phone Number: 020-87334687; Email: zoccrc@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Zhongshan Ophthalmic Center
      • Contact: hui Yang, PHD; Phone Number: +8613710584767
      • Contact: 中国; Phone Number: +8613710584767

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

250

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Patients were sub-divided into an AQP4 seropositive group and an AQP4 seronegative group, according to blood test of the AQP4-Ab.
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; Patients were sub-divided into an AQP4 seropositive group and an AQP4 seronegative group, according to blood test of the AQP4-Ab.
Healthy controls; Age- and gender- matched healthy controls.	Biological: blood test of anti-AQP4 antibody; Patients were sub-divided into an AQP4 seropositive group and an AQP4 seronegative group, according to blood test of the AQP4-Ab.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xiujuan Zhao
• Investigators: Study Director: Hui Yang, World Health Organization

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): August 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: August 7, 2016
• First Submitted That Met QC Criteria: August 26, 2016
• First Posted (Estimate): September 1, 2016

Study Record Updates

• Last Update Posted (Estimate): September 1, 2016
• Last Update Submitted That Met QC Criteria: August 26, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Neuritis; Optic Neuritis; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: 2014meky049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided