PERG and mfPERG in Band Atrophy

This study has been completed.

Sponsor:

Collaborator:

Fundação de Amparo à Pesquisa do Estado de São Paulo

Information provided by:

University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT00553761

First received: November 5, 2007

Last updated: August 4, 2011

Last verified: November 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

November 5, 2007

Last Updated Date

August 4, 2011

Start Date ^ICMJE

August 2006

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00553761 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

PERG and mfPERG in Band Atrophy

Official Title ^ICMJE

Pattern Electroretinogram and Multifocal Pattern Electroretinogram For the Detection of Neural Loss in Patients With Permanent Temporal Visual Field Defect From Chiasmal Compression

Brief Summary

The study is designed to evaluate the ability of pattern electroretinogram (PERG) and multifocal pattern electroretinogram (mfPERG) to measure and identify the pattern of band atrophy of the optic nerve in patients with long standing chiasmal lesions. The hypothesis is that these electrophysiological tests were able to identify this such pattern. The idea is to investigate the ability of the these electrophysiological technics in detecting the neural loss from chiasmal compression and to evaluate the ability of PERG and mfPERG parameters to differentiate between eyes with band atrophy of the optic nerve and healthy eyes.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients with band atrophy from chismal compression and controls

Condition ^ICMJE

Band Atrophy

Intervention ^ICMJE

Device: Pattern electroretinogram

Full field and hemifield (nasal and temporal) stimulation transient pattern electroretinogram (PERG) were recorded both in patients and controls.

Study Group/Cohort (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

July 2009

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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
Anormal nasal field

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT00553761

Other Study ID Numbers ^ICMJE

654/06, FAPESP 06/61549-6; 07/54142-0)

Has Data Monitoring Committee

Responsible Party

Mario Luiz Ribeiro Monteiro/University of Sao Paulo, University of Sao Paulo

Study Sponsor ^ICMJE

University of Sao Paulo

Collaborators ^ICMJE

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators ^ICMJE

Study Chair:

Mário Luiz R Monteiro, PhD

University of Sao Paulo

Information Provided By

University of Sao Paulo

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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