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

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ClinicalTrials.gov Identifier: NCT02886377
Recruitment Status : Unknown
Verified August 2016 by Xiujuan Zhao, Zhongshan Ophthalmic Center, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : September 1, 2016
Last Update Posted : September 1, 2016
Sponsor:
Information provided by (Responsible Party):
Xiujuan Zhao, Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

Condition or disease Intervention/treatment
Optic Neuritis 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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: The Correlation Between AQP-4 Ab and the Visual Function of Patients With Demyelinating ON at Onset
Study Start Date : November 2013
Actual Primary Completion Date : August 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. retinal nerve fiber layer thickness [ Time Frame: 2013.11-2016.12 ]

Secondary Outcome Measures :
  1. visual field [ Time Frame: 2013.11-2016.12 ]
  2. visual evoked potential [ Time Frame: 2013.11-2016.12 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
250
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02886377


Contacts
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Contact: Jian Zhang 020-87334687 zoccrc@mail.sysu.edu.cn

Locations
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China, Guangdong
Zhongshan Ophthalmic Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: hui Yang, PHD    +8613710584767      
Contact    +8613710584767      
Sponsors and Collaborators
Xiujuan Zhao
Investigators
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Study Director: Hui Yang World Health Organization

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Responsible Party: Xiujuan Zhao, doctor, Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02886377     History of Changes
Other Study ID Numbers: 2014meky049
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Neuritis
Optic Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs