Band AtrophyNCT00553761
PERG and mfPERG in Band Atrophy
An observational study of Band Atrophy, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Band Atrophy
- What is being tested?
- Pattern electroretinogram
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2006to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with band atrophy from chismal compression and controls
Who may be able to join
- Visual acuity better than 20/30
- Refractive error less 5 spherical diopter and 3 cylinder diopter
- Temporal field defect
Who cannot join
- Presence of glaucoma and optic nerve anomalies
- Anormal nasal field
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pattern Electroretinogram and Multifocal Pattern Electroretinogram For the Detection of Neural Loss in Patients With Permanent Temporal Visual Field Defect From Chiasmal Compression
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.
- Conditions
- Band Atrophy
- Being tested
- Pattern electroretinogram
- Keywords
- Band atrophy, Pattern electroretinogram, Chiasmal compression, Neural loss, Electrophysiological tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pattern electroretinogramDevice
Full field and hemifield (nasal and temporal) stimulation transient pattern electroretinogram (PERG) were recorded both in patients and controls.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startAug 2006
- Primary completionJul 2008
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Band AtrophyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Mário Luiz R Monteiro, PhD, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553761
- Sponsor's protocol ID
- 654/06
- Other IDs
- FAPESP 06/61549-6; 07/54142-0)
- Status last verified
- Nov 2007
- First submitted
- 5 Nov 2007
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23052713Monteiro 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.
PubMed 21415059Monteiro 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.
PubMed 19264884Cunha 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.
PubMed 18401605
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern Electroretinogram and Multifocal Pattern Electroretinogram For the Detection of Neural Loss in Patients With Permanent Temporal Visual Field Defect From Chiasmal Compression
- ClinicalTrials.gov ID
- NCT00553761
- Acronym / sponsor ID
- 654/06
- Conditions
- Band Atrophy
- Keywords
- Band atrophy, Pattern electroretinogram, Chiasmal compression, Neural loss, Electrophysiological tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Aug 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 6 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with band atrophy from chismal compression and controls
Key inclusion criteria (3 listed)
- Visual acuity better than 20/30
- Refractive error less 5 spherical diopter and 3 cylinder diopter
- Temporal field defect
Key exclusion criteria (2 listed)
- Presence of glaucoma and optic nerve anomalies
- Anormal nasal field
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pattern electroretinogramFull field and hemifield (nasal and temporal) stimulation transient pattern electroretinogram (PERG) were recorded both in patients and controls. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2011.
- Derived from this study: PubMed 23052713Monteiro 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.
- Derived from this study: PubMed 21415059Monteiro 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.
- Derived from this study: PubMed 19264884Monteiro 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.
- Derived from this study: PubMed 18401605Cunha 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.
- Pattern Electroretinograms For the Detection of Neural Loss in Patients with Permanent Temporal Visual Field Defect from Chiasmal CompressionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mário Luiz R Monteiro, PhD study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Band Atrophy, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00553761, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2011.