Band AtrophyNCT00607100
High-Resolution Optical Coherence Tomography for Detection of Retinal Nerve Fiber Layer Loss in Band Atrophy of the Optic Nerve
An observational study of Band Atrophy and Chiasmal Compression, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Band Atrophy, Chiasmal Compression, Neural Loss
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2007to Dec 2008
- 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
- Healthy volunteers accepted
- 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
- A normal nasal field
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo - Ophthalmology Department
São Paulo, São Paulo, 05403-000
About this study
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.
- Conditions
- Band Atrophy, Chiasmal Compression, Neural Loss
- Keywords
- High-Resolution Optical Coherence Tomography, Retinal Nerve Fiber Layer, Band Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with Band atrophy of the optic nerve | |
| 2 | Normal Controls |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionMar 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Investigators
- Luciana Costa Cunha, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607100
- Sponsor's protocol ID
- CAPPESQ N. 1056/07
- Status last verified
- Nov 2008
- First submitted
- 4 Feb 2008
- Last updated
- 13 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18774548
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Resolution Optical Coherence Tomography for Detection of Retinal Nerve Fiber Layer Loss in Band Atrophy of the Optic Nerve
- ClinicalTrials.gov ID
- NCT00607100
- Acronym / sponsor ID
- CAPPESQ N. 1056/07
- Conditions
- Band Atrophy, Chiasmal Compression, Neural Loss
- Keywords
- High-Resolution Optical Coherence Tomography, Retinal Nerve Fiber Layer, Band Atrophy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Mar 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 5 Feb 2008 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with Band atrophy of the optic nerve |
| 2 | – | –Normal Controls |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- 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
- A normal 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.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2008.
- Derived from this study: PubMed 18774548Costa-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.
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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.
Luciana Costa Cunha, MD principal investigator
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 and Chiasmal Compression, 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: status not confirmed, as of the sponsor's last update on 13 Nov 2008. 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?
Results are not available in the source record.
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 NCT00607100, which also lists 1 linked publication.
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 13 Nov 2008.