- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01024985
Evaluation of Neural Loss in Multiple Sclerosis and Neuromyelitis Optica Using High Resolution Oct
June 24, 2010 updated by: University of Sao Paulo
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.
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sao Paulo, Brazil, 05403-000
- Recruiting
- Hospital Das Clinicas Medical School of University of Sao Paulo
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Contact:
- heloisa helena, nurse
- Phone Number: 55 11 3069 6596
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Sub-Investigator:
- danilo B fernandes, md
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Sub-Investigator:
- kenzo hokazono, md
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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controls
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multiple sclerosis
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neuromyelitis optica
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hokazono K, Raza AS, Oyamada MK, Hood DC, Monteiro ML. Pattern electroretinogram in neuromyelitis optica and multiple sclerosis with or without optic neuritis and its correlation with FD-OCT and perimetry. Doc Ophthalmol. 2013 Dec;127(3):201-15. doi: 10.1007/s10633-013-9401-2. Epub 2013 Jul 30.
- Monteiro ML, Fernandes DB, Apostolos-Pereira SL, Callegaro D. Quantification of retinal neural loss in patients with neuromyelitis optica and multiple sclerosis with or without optic neuritis using Fourier-domain optical coherence tomography. Invest Ophthalmol Vis Sci. 2012 Jun 26;53(7):3959-66. doi: 10.1167/iovs.11-9324.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Anticipated)
December 1, 2010
Study Completion (Anticipated)
December 1, 2011
Study Registration Dates
First Submitted
December 2, 2009
First Submitted That Met QC Criteria
December 2, 2009
First Posted (Estimate)
December 3, 2009
Study Record Updates
Last Update Posted (Estimate)
June 28, 2010
Last Update Submitted That Met QC Criteria
June 24, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Eye Diseases
- Optic Nerve Diseases
- Cranial Nerve Diseases
- Myelitis, Transverse
- Optic Neuritis
- Multiple Sclerosis
- Sclerosis
- Neuromyelitis Optica
Other Study ID Numbers
- 0190/09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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