NCT00553761

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

August 8, 2011

Status Verified

November 1, 2007

Enrollment Period

1.9 years

First QC Date

November 5, 2007

Last Update Submit

August 4, 2011

Conditions

Keywords

Band atrophyPattern electroretinogramChiasmal compressionNeural lossElectrophysiological tests

Interventions

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with band atrophy from chismal compression and controls

You may qualify if:

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

You may not qualify if:

  • Presence of glaucoma and optic nerve anomalies
  • Anormal nasal field

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade de São Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (4)

  • Monteiro ML, Hokazono K, Cunha LP, Oyamada MK. Correlation between multifocal pattern electroretinography and Fourier-domain OCT in eyes with temporal hemianopia from chiasmal compression. Graefes Arch Clin Exp Ophthalmol. 2013 Mar;251(3):903-15. doi: 10.1007/s00417-012-2156-8. Epub 2012 Sep 29.

  • Monteiro ML, Hokazono K, Cunha LP, Oyamada MK. Multifocal pattern electroretinography for the detection of neural loss in eyes with permanent temporal hemianopia or quadrantanopia from chiasmal compression. Br J Ophthalmol. 2012 Jan;96(1):104-9. doi: 10.1136/bjo.2010.199661. Epub 2011 Mar 17.

  • Monteiro ML, Cunha LP, Costa-Cunha LV, Maia OO Jr, Oyamada MK. Relationship between optical coherence tomography, pattern electroretinogram and automated perimetry in eyes with temporal hemianopia from chiasmal compression. Invest Ophthalmol Vis Sci. 2009 Aug;50(8):3535-41. doi: 10.1167/iovs.08-3093. Epub 2009 Mar 5.

  • Cunha LP, Oyamada MK, Monteiro ML. Pattern electroretinograms for the detection of neural loss in patients with permanent temporal visual field defect from chiasmal compression. Doc Ophthalmol. 2008 Nov;117(3):223-32. doi: 10.1007/s10633-008-9126-9. Epub 2008 Apr 10.

Related Links

Study Officials

  • Mário Luiz R Monteiro, PhD

    University of Sao Paulo

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 5, 2007

First Posted

November 6, 2007

Study Start

August 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2009

Last Updated

August 8, 2011

Record last verified: 2007-11

Locations