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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029385
Receipt No. R000033582
Scientific Title Exploratory study on biomaker for early detection of glaucoma using MRI
Date of disclosure of the study information 2017/10/10
Last modified on 2019/04/04

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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
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
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/ctr_e/ctr_view.cgi?recptno=R000033582

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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