UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006900 |
|---|---|
| Receipt number | R000008154 |
| Scientific Title | Retinal imaging using optical coherence tomography in various optic neuropathies |
| Date of disclosure of the study information | 2011/12/19 |
| Last modified on | 2020/12/23 13:52:14 |
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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
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
ganka@med.kobe-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Kobe University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008154
| 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 |
