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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Sao Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01024985
First received: December 2, 2009
Last updated: June 24, 2010
Last verified: June 2010
History of Changes
  Purpose

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
Multiple Sclerosis
Neuromyelitis Optica

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Estimated Enrollment: 40
Study Start Date: September 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
multiple sclerosis
neuromyelitis optica
controls

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024985

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

Locations
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

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: mario luiz ribeiro monteiro, university of sao paulo
ClinicalTrials.gov Identifier: NCT01024985     History of Changes
Other Study ID Numbers: 0190/09
Study First Received: December 2, 2009
Last Updated: June 24, 2010
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
optic neuritis
longitudinally extensive transverse myelitis
retinal nerve fiber layer
macular thickness

Additional relevant MeSH terms:
Neuromyelitis Optica
Multiple Sclerosis
Sclerosis
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
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013