UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study on biomaker for early detection of glaucoma using MRI
Acronym	Early detection of glaucoma using MRI
Scientific Title	Exploratory study on biomaker for early detection of glaucoma using MRI
Scientific Title:Acronym	Early detection of glaucoma using MRI
Region	Japan

Condition
Condition	Glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate optical nerve function and retinal image of glaucoma patients using MRI-DTI and OCT. To examine correlation between FA value, RNFT and intraocular pressure.
Basic objectives2	Others
Basic objectives -Others	Exploratory study of biomarker(s)
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Relationship between fractional anisotropy value, retinal nerve fiber thickness and intraocular pressure
Key secondary outcomes	Relationship between fractional anisotropy value, retinal nerve fiber thickness, intraocular pressure and visual field loss

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	MRI measurement Once
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patient diagnosed with glaucoma of 20 years or older (primary open angle glaucoma and normal tension glaucoma) 2. Written consent by themselves is given before screening. 3. Written consent by themselves is given for using the data of patient background and image for the research 4. Patient who has left /right difference of visual field defect or retinal nerve fiber layer thickness around the optic disc
Key exclusion criteria	1. Patient who is judged inappropriate by an investigator. 2. Patient who disagrees to the study 3. Patient to be taken MRI difficultly (patient who cannot understand instructions or dementia patients) 4. Patient who inappropriate for MRI (MR noncompliant electronic products and metal fixtures, surgical devices such as metal coils and clips, medical devices such as non-MR compliant cardiac pacemakers, claustrophobia, tattooing, wearing unremovable metal products in the body)
Target sample size	10

Research contact person
Last name of lead principal investigator	1st name Kazuo Middle name Last name Umemura
Organization	Hamamatsu University School of Medicine
Division name	Pharmacology
Zip code	4313192
Address	1-20-1 Handayama Higashiku Hamamatsu
TEL	053-435-2269
Email	umemura@hama-med.ac.jp

Public contact
1st name of contact person	1st name Kazuo Middle name Last name Umemura
Organization	Hamamatsu University School of Medicine
Division name	Pharmacology
Zip code	4313192
Address	1-20-1 Handayama Higashiku Hamamatsu
TEL	053-435-2269
Homepage URL
Email	umemura@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hamamatsu Pharma Research
Name of secondary funder(s)	Hamamatsu Pharma Research

IRB Contact (For public release)
Organization	IRB in Hamamatsu University Hospital
Address	1-20-1 Handayama Higashiku Hamamatsu
Tel	053-435-2680
Email	rinri@hama-med.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	浜松医科大学附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 10 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	Completed
Date of protocol fixation	2017 Year 10 Month 06 Day
Date of IRB	2017 Year 10 Month 06 Day
Anticipated trial start date	2017 Year 10 Month 11 Day
Last follow-up date	2019 Year 03 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	2017 Year 10 Month 02 Day
Last modified on	2019 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033582