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Evaluation of Neural Loss in Multiple Sclerosis and Neuromyelitis Optica Using High Resolution Oct

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ClinicalTrials.gov Identifier: NCT01024985
Recruitment Status : Unknown
Verified June 2010 by University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : December 3, 2009
Last Update Posted : June 28, 2010
Sponsor:
Information provided by:
University of Sao Paulo

Study Description
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Brief Summary:
The purpose of this study is to determine the ability of STRATUS OCT and high resolution OCT to detect and to quantify the neural loss in multiple sclerosis and neuromyelitis optica and its subtypes.

Condition or disease
Multiple Sclerosis Neuromyelitis Optica

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Macular and Retinal Nerve Fiber Layer Thickness Measurements for Detection of Neural Loss in Multiple Sclerosis and Neuromyelitis Optica Using High Resolution Optical Coherence Tomography.
Study Start Date : September 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
multiple sclerosis
neuromyelitis optica
controls


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
patients of ophthalmology and/or neurology departments of hopital das clinicas of medical school of university of sao paulo
Criteria

Inclusion Criteria:

  • clinical diagnosis of multiple sclerosis or neuromyelitis optica
  • age between 15 and 60 years
  • BCVA better than 20/400
  • no optic neuritis crisis in the last 6 months

Exclusion Criteria:

  • diagnosis of glaucoma, opacities or disc anomalies
  • diagnosis of macular disease
  • disc swelling at fundoscopy
Contacts and Locations
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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): NCT01024985


Contacts
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Contact: mario luiz r monteiro, phd 55 11 30697871 mlrmonteiro@terra.com.br

Locations
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Brazil
Hospital Das Clinicas Medical School of University of Sao Paulo Recruiting
Sao Paulo, Brazil, 05403-000
Contact: heloisa helena, nurse    55 11 3069 6596      
Sub-Investigator: danilo B fernandes, md         
Sub-Investigator: kenzo hokazono, md         
Sponsors and Collaborators
University of Sao Paulo
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: mario luiz ribeiro monteiro, university of sao paulo
ClinicalTrials.gov Identifier: NCT01024985    
Other Study ID Numbers: 0190/09
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: June 28, 2010
Last Verified: June 2010
Keywords provided by University of Sao Paulo:
optic neuritis
longitudinally extensive transverse myelitis
retinal nerve fiber layer
macular thickness
Additional relevant MeSH terms:
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Multiple Sclerosis
Neuromyelitis Optica
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
 Autoimmune Diseases
Immune System Diseases
Myelitis, Transverse
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases