UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008108 |
|---|---|
| Receipt number | R000009523 |
| Scientific Title | Usefulness of the Laser speckle flowgraphy(LSFG-NAVI®)for the differential diagnosis between Non-arteritic ischemic optic neuropathy and anterior optic neuritis |
| Date of disclosure of the study information | 2012/07/01 |
| Last modified on | 2012/06/05 19:49:58 |
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Basic information
Public title
Usefulness of the Laser speckle flowgraphy(LSFG-NAVI®)for the differential diagnosis between Non-arteritic ischemic optic neuropathy and anterior optic neuritis
Acronym
Usefulness of the Laser speckle flowgraphy(LSFG-NAVI®)for the differential diagnosis of optic neuropathy.
Scientific Title
Usefulness of the Laser speckle flowgraphy(LSFG-NAVI®)for the differential diagnosis between Non-arteritic ischemic optic neuropathy and anterior optic neuritis
Scientific Title:Acronym
Usefulness of the Laser speckle flowgraphy(LSFG-NAVI®)for the differential diagnosis of optic neuropathy.
Region
| Japan |
Condition
Condition
Non-arteritic ischemic optic neuropathy and anterior optic neuritis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of laser speckle flowgraphy (LSFG) to
differentiate between acute non-arteritic ischemic optic neuropathy (NAION) and
anterior optic neuritis (ON).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Optic nerve head blood flow in patients with Non-arteritic ischemic optic neuropathy(NAION) and anterior optic neuritis(Anterior ON).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Group:Non-Arteritic Ischemic Optic Neuropathy(NAION)
Priod:The first visit only
Number of times: 1
Use equipment:LSFG-NAVI®;Softcare(Fukuoka)
Interventions/Control_2
Group:Anterior Optic neuropathy(Anterior ON)
Priod:The first visit only
Number of times: 1
Use equipment:LSFG-NAVI®;Softcare(Fukuoka)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients of 20 years old or older the time of obtained informed consent.
2.Patients with NAION and Anterior ON within four weeks from the onset.
3.Patient who received an adequate explanation to participate this study,fully understood,and voluntary signed the consent document
Key exclusion criteria
1.Patients who is not qualified to be subject for the study including media opacity,retinal vascular disease,and internal carotid artery disease.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Chuman |
Organization
University of Miyazaki
Division name
Ophthalmology
Zip code
Address
5200,Kihara,Kiyotake-cho,Miyazaki city,MIYAZAKI,JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Maekubo |
Organization
University of Miyazaki
Division name
Ophthalmology
Zip code
Address
TEL
Homepage URL
tomomae@fc.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2012 | Year | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 05 | Day |
Last modified on
| 2012 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009523
