Evaluation of Neural Loss in Multiple Sclerosis and Neuro... | NCT01024985

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

NCT01024985

Sponsor

University of Sao Paulo

Status

Unknown status

Last Update Posted

Jun 28, 2010Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Multiple Sclerosis
Neuromyelitis Optica

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Dec 2, 2009

First Submission Date that Met QC Criteria

Dec 2, 2009

First Posted Date

Dec 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2010

Last Update Posted Date

Jun 28, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
mario luiz r monteiro, phd	Contact	55 11 30697871		mlrmonteiro@terra.com.br

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Das Clinicas Medical School of University of Sao Paulo	Recruiting	São Paulo	São Paulo	05403-000	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23892551	Derived	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.
22589446	Derived

ID	Term
D009103	Multiple Sclerosis
D009471	Neuromyelitis Optica
D009902	Optic Neuritis

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases