Multiple SclerosisNCT01024985
Evaluation of Neural Loss in Multiple Sclerosis and Neuromyelitis Optica Using High Resolution Oct
An observational study of Multiple Sclerosis and Neuromyelitis Optica, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to determine the ability of STRATUS OCT and high resolution OCT to detect and to quantify the neural loss in multiple sclerosis and neuromyelitis optica and its subtypes. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Neuromyelitis Optica
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2009to Dec 2011
- 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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: patients of ophthalmology and/or neurology departments of hopital das clinicas of medical school of university of sao paulo
Who may be able to join
- clinical diagnosis of multiple sclerosis or neuromyelitis optica
- age between 15 and 60 years
- BCVA better than 20/400
- no optic neuritis crisis in the last 6 months
Who cannot join
- diagnosis of glaucoma, opacities or disc anomalies
- diagnosis of macular disease
- disc swelling at fundoscopy
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Das Clinicas Medical School of University of Sao Paulo
São Paulo, São Paulo, 05403-000
heloisa helena, nurse, 55 11 3069 6596
danilo B fernandes, md
About this study
Official title: Evaluation of Macular and Retinal Nerve Fiber Layer Thickness Measurements for Detection of Neural Loss in Multiple Sclerosis and Neuromyelitis Optica Using High Resolution Optical Coherence Tomography.
The purpose of this study is to determine the ability of STRATUS OCT and high resolution OCT to detect and to quantify the neural loss in multiple sclerosis and neuromyelitis optica and its subtypes.
- Conditions
- Multiple Sclerosis, Neuromyelitis Optica
- Keywords
- optic neuritis, longitudinally extensive transverse myelitis, retinal nerve fiber layer, macular thickness
- Medical subject headings
- Multiple Sclerosis, Neuromyelitis Optica, Optic Neuritis
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 |
|---|---|---|
| multiple sclerosis | Not described | |
| neuromyelitis optica | Not described | |
| controls | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024985
- Sponsor's protocol ID
- 0190/09
- Status last verified
- Jun 2010
- First submitted
- 2 Dec 2009
- Last updated
- 28 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Hokazono K, Raza AS, Oyamada MK, Hood DC, Monteiro ML. Pattern electroretinogram in neuromyelitis optica and multiple sclerosis with or without optic neuritis and its correlation with FD-OCT and perimetry. Doc Ophthalmol. 2013 Dec;127(3):201-15. doi: 10.1007/s10633-013-9401-2. Epub 2013 Jul 30.
PubMed 23892551Monteiro ML, Fernandes DB, Apostolos-Pereira SL, Callegaro D. Quantification of retinal neural loss in patients with neuromyelitis optica and multiple sclerosis with or without optic neuritis using Fourier-domain optical coherence tomography. Invest Ophthalmol Vis Sci. 2012 Jun 26;53(7):3959-66. doi: 10.1167/iovs.11-9324.
PubMed 22589446
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Macular and Retinal Nerve Fiber Layer Thickness Measurements for Detection of Neural Loss in Multiple Sclerosis and Neuromyelitis Optica Using High Resolution Optical Coherence Tomography.
- ClinicalTrials.gov ID
- NCT01024985
- Acronym / sponsor ID
- 0190/09
- Conditions
- Multiple Sclerosis, Neuromyelitis Optica
- Keywords
- optic neuritis, longitudinally extensive transverse myelitis, retinal nerve fiber layer, macular thickness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 3 Dec 2009 (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 determine the ability of STRATUS OCT and high resolution OCT to detect and to quantify the neural loss in multiple sclerosis and neuromyelitis optica and its subtypes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| multiple sclerosis | – | – |
| neuromyelitis optica | – | – |
| controls | – | – |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- patients of ophthalmology and/or neurology departments of hopital das clinicas of medical school of university of sao paulo
Key inclusion criteria (4 listed)
- clinical diagnosis of multiple sclerosis or neuromyelitis optica
- age between 15 and 60 years
- BCVA better than 20/400
- no optic neuritis crisis in the last 6 months
Key exclusion criteria (3 listed)
- diagnosis of glaucoma, opacities or disc anomalies
- diagnosis of macular disease
- disc swelling at fundoscopy
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 28 Jun 2010.
- Derived from this study: PubMed 23892551Hokazono K, Raza AS, Oyamada MK, Hood DC, Monteiro ML. Pattern electroretinogram in neuromyelitis optica and multiple sclerosis with or without optic neuritis and its correlation with FD-OCT and perimetry. Doc Ophthalmol. 2013 Dec;127(3):201-15. doi: 10.1007/s10633-013-9401-2. Epub 2013 Jul 30.
- Derived from this study: PubMed 22589446Monteiro ML, Fernandes DB, Apostolos-Pereira SL, Callegaro D. Quantification of retinal neural loss in patients with neuromyelitis optica and multiple sclerosis with or without optic neuritis using Fourier-domain optical coherence tomography. Invest Ophthalmol Vis Sci. 2012 Jun 26;53(7):3959-66. doi: 10.1167/iovs.11-9324.
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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.
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 Multiple Sclerosis and Neuromyelitis Optica, 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 4 inclusion and 3 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 28 Jun 2010. 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?
Contact mario luiz r monteiro, phd (55 11 30697871, mlrmonteiro@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01024985, which also lists 2 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 28 Jun 2010.