UMIN-CTR Clinical Trial

Basic information
Public title	Retinal imaging using optical coherence tomography in various optic neuropathies
Acronym	Retinal imaging using optical coherence tomography in various optic neuropathies
Scientific Title	Retinal imaging using optical coherence tomography in various optic neuropathies
Scientific Title:Acronym	Retinal imaging using optical coherence tomography in various optic neuropathies
Region	Japan

Condition
Condition	Optic neuropathy,Healthy volunteers,
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To take retinal images with optical coherence tomograph and evaluate structural changes in various optic neuropathy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Retinal layered architecture
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	To examine eligibility and take OCT images in a day.
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1.Healthy volunteers, or patients with: optic neuropathies (e.g. glaucoma, traumatic optic neuropathy) 2. Subjects who sign an informed consent form to participate in the clinical study
Key exclusion criteria	Subjects who a doctor in attendance declares ineligible for any reason
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Nakamura
Organization	Kobe University Graduate School of Medicine
Division name	Ophthalmology
Zip code	6500017
Address	7-5-1,Kusunoki-cho,Chuo-ku,Kobe
TEL	0783825111
Email	ganka@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Akiyasu Middle name Last name Kanamori
Organization	Kobe University Graduate School of Medicine
Division name	Ophthalmology
Zip code	6500017
Address	7-5-1,Kusunoki-cho,Chuo-ku,Kobe
TEL	0783825111
Homepage URL
Email	ganka@med.kobe-u.ac.jp

Sponsor
Institute	Department of Ophthalmology, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
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	Kobe Univ.I
Address	7-5-1, Kusunokicho, chuoku, Kobe
Tel	078-382-6048
Email	kanaaki@med.kobe-u.ac.jp

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	2011 Year 12 Month 19 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	Enrolling by invitation
Date of protocol fixation	2011 Year 12 Month 17 Day
Date of IRB	2012 Year 12 Month 20 Day
Anticipated trial start date	2013 Year 01 Month 01 Day
Last follow-up date	2026 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 12 Month 17 Day
Last modified on	2020 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008154