High-Resolution Optical Coherence Tomography for Detectio... | NCT00607100

Studies
High-Resolution Optical Coherence Tomography for Detection of Retinal Nerve Fiber Layer Loss in Band Atrophy of the Optic Nerve

NCT00607100

Sponsor

University of Sao Paulo

Status

Unknown status

Last Update Posted

Nov 13, 2008Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Band Atrophy
Chiasmal Compression
Neural Loss

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

Nov 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Mar 2008Estimated

Completion Date

Dec 2008Estimated

First Submitted Date

Feb 4, 2008

First Submission Date that Met QC Criteria

Feb 4, 2008

First Posted Date

Feb 5, 2008Estimated

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

Nov 11, 2008

Last Update Posted Date

Nov 13, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 compare the abilities of high-speed,high-resolution (HR) optical coherence tomography (OCT) and Stratus OCT for detection of retinal nerve fiber layer (RNFL) loss in eyes with band atrophy (BA) of the optic nerve.

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients with Band atrophy of the optic nerve
2		Normal Controls

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Visual acuity better than 20/30
Refractive error less 5 spherical diopter and 3 cylinder diopter
Temporal field defect

Exclusion Criteria:

Presence of glaucoma and optic nerve anomalies
A normal nasal field

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with band atrophy from chismal compression and controls

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luciana Costa Cunha, MD	University of Sao Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of São Paulo - Ophthalmology Department		São Paulo	São Paulo	05403-000	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18774548	Derived	Costa-Cunha LV, Cunha LP, Malta RF, Monteiro ML. Comparison of Fourier-domain and time-domain optical coherence tomography in the detection of band atrophy of the optic nerve. Am J Ophthalmol. 2009 Jan;147(1):56-63.e2. doi: 10.1016/j.ajo.2008.07.020. Epub 2008 Sep 6.