NCT01024985

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 28, 2010

Status Verified

June 1, 2010

Enrollment Period

1.2 years

First QC Date

December 2, 2009

Last Update Submit

June 24, 2010

Conditions

Keywords

optic neuritislongitudinally extensive transverse myelitisretinal nerve fiber layermacular thickness

Study Arms (3)

multiple sclerosis

neuromyelitis optica

controls

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

patients of ophthalmology and/or neurology departments of hopital das clinicas of medical school of university of sao paulo

You may qualify if:

  • 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

You may not qualify if:

  • diagnosis of glaucoma, opacities or disc anomalies
  • diagnosis of macular disease
  • disc swelling at fundoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Das Clinicas Medical School of University of Sao Paulo

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Multiple SclerosisNeuromyelitis OpticaOptic Neuritis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesMyelitis, TransverseOptic Nerve DiseasesCranial Nerve DiseasesEye Diseases

Central Study Contacts

mario luiz r monteiro, phd

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 3, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2011

Last Updated

June 28, 2010

Record last verified: 2010-06

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