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

Optic Neuritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02886377
• Other study ID #: 2014meky049
• Status: Recruiting
• Phase: N/A
• First received: August 7, 2016
• Last updated: August 26, 2016
• Start date: November 2013
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: Zhongshan Ophthalmic Center, Sun Yet-san University
• Contact: Jian Zhang
• Phone: 020-87334687
• Email: zoccrc[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Neuritis
• Optic Neuritis

Intervention

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.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Xiujuan Zhao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	retinal nerve fiber layer thickness		2013.11-2016.12	Yes
Secondary	visual field		2013.11-2016.12	Yes
Secondary	visual evoked potential		2013.11-2016.12	Yes