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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00553761
Other study ID # 654/06
Secondary ID FAPESP 06/61549-
Status Completed
Phase N/A
First received November 5, 2007
Last updated August 4, 2011
Start date August 2006
Est. completion date July 2009

Study information

Verified date November 2007
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 2009
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1. Visual acuity better than 20/30

2. Refractive error less 5 spherical diopter and 3 cylinder diopter

3. Temporal field defect

Exclusion Criteria:

1. Presence of glaucoma and optic nerve anomalies

2. Anormal nasal field

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Brazil Universidade de São Paulo São Paulo

Sponsors (2)

Lead Sponsor Collaborator
University of Sao Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

See also
  Status Clinical Trial Phase
Active, not recruiting NCT00607100 - High-Resolution Optical Coherence Tomography for Detection of Retinal Nerve Fiber Layer Loss in Band Atrophy of the Optic Nerve N/A