UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022647 |
|---|---|
| Receipt number | R000025405 |
| Scientific Title | Usefulness of Laser speckle flowgraphy(LSFG) and the enhanced depth imaging optical coherence tomography (EDI-OCT) for the differential diagnosis between Non-arteritic ischemic optic neuropathy and optic neuritis |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2016/06/07 19:12:31 |
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Basic information
Public title
Usefulness of Laser speckle flowgraphy(LSFG) and the enhanced depth imaging optical coherence tomography (EDI-OCT) for the differential diagnosis between Non-arteritic ischemic optic neuropathy and optic neuritis
Acronym
Usefulness of LSFG and EDI-OCT for diagnosis of optic neuropathy.
Scientific Title
Usefulness of Laser speckle flowgraphy(LSFG) and the enhanced depth imaging optical coherence tomography (EDI-OCT) for the differential diagnosis between Non-arteritic ischemic optic neuropathy and optic neuritis
Scientific Title:Acronym
Usefulness of LSFG and EDI-OCT for diagnosis of optic neuropathy.
Region
| Japan |
Condition
Condition
Non-arteritic ischemic optic neuropathy
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) and enhanced depth imaging optical coherence tomography (EDI-OCT) to differentiate between acute non-arteritic ischemic optic neuropathy (NAION) and 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
(at onset, 1 month later, and 3 months later)
Key secondary outcomes
Choroidal blood flow
Choroidal thickness
Visual acuity
Visual field
Blood pressure
Intraocular pressure
(at onset, 1 month later, and 3 months later)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients of 16 years old or older the time of obtained informed consent.
2. Patients who received an adequate explanation to participate this study,fully understood,and voluntary signed the consent document, or whose parent did that.
Key exclusion criteria
1. Patients of 80 years old or older the time of obtained informed consent.
2. Patients who have high myopia.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Shinmei |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
N-15, W-7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5944
yshinmei@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuka Suimon |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
N-15, W-7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5944
Homepage URL
suimonyuka@gmail.com
Sponsor or person
Institute
Department of Ophthalmology Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2016 | 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
| 2016 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Priod: 3 months
Number of times: 3
Use equipment: LSFG-NAVI® Softcare (Fukuoka)
Management information
Registered date
| 2016 | Year | 06 | Month | 07 | Day |
Last modified on
| 2016 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025405
