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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022647
Receipt No. 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

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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
Email 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
Email suimonyuka@gmail.com

Sponsor
Institute Department of Ophthalmology Hokkaido University Graduate School of Medicine
Institute
Department

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
Email

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&reg; 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025405

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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