UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yasuhiro Shinmei
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Ophthalmology
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	Yuka Suimon
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Ophthalmology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 03 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025405