UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029385 |
|---|---|
| Receipt number | 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 09:10:04 |
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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
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
umemura@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033582
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
