UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017580 |
|---|---|
| Receipt number | R000020375 |
| Scientific Title | Investigate and developt of non-invasive fundus oximetry |
| Date of disclosure of the study information | 2015/05/15 |
| Last modified on | 2015/05/15 10:59:31 |
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Basic information
Public title
Investigate and developt of non-invasive fundus oximetry
Acronym
Investigation of fundus oximetry
Scientific Title
Investigate and developt of non-invasive fundus oximetry
Scientific Title:Acronym
Investigation of fundus oximetry
Region
| Japan |
Condition
Condition
Fundus deseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate and develop of novel fundus oximetry.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fundus images.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 10 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons with provision of written informed consent regarding study participation, data collection of fundus images, data analysis of fundus images, collection of medical records at patients examinations and analysis of medical records at patients examinations.
Key exclusion criteria
1:Cases of that were unable to take fundus images.
2:Cases of that were considered excluded by ophthalmologist.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Enaida |
Organization
Saga university of faculty of medicine
Division name
Department of ophthalmology
Zip code
Address
5-1-1 Nabeshima, Saga 849-8501, Japan
TEL
0952-34-2384
enaida@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Ishikawa |
Organization
Saga university of faculty of medicine
Division name
Department of ophthalmology
Zip code
Address
-1-1 Nabeshima, Saga 849-8501, Japan
TEL
0952-34-2384
Homepage URL
c1441@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga university
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyusyu university
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 05 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study. Random sampling.
Management information
Registered date
| 2015 | Year | 05 | Month | 15 | Day |
Last modified on
| 2015 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020375
