UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015299 |
|---|---|
| Receipt number | R000013767 |
| Scientific Title | Observation study of the retina by Adaptive Optics Scanning Laser Ophthalmoscopy (AO-SLO) |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2014/10/01 00:06:05 |
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Basic information
Public title
Observation study of the retina by Adaptive Optics Scanning Laser Ophthalmoscopy (AO-SLO)
Acronym
Observation study of the retina by Adaptive Optics Scanning Laser Ophthalmoscopy (AO-SLO)
Scientific Title
Observation study of the retina by Adaptive Optics Scanning Laser Ophthalmoscopy (AO-SLO)
Scientific Title:Acronym
Observation study of the retina by Adaptive Optics Scanning Laser Ophthalmoscopy (AO-SLO)
Region
| Japan |
Condition
Condition
Retinal disease , healthy people
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By the use of the adaptive optics scanning laser ophthalmoscope(AO-SLO) , retinal vasculature and visual cells which were undetectable until now can be seen in greater detail.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Density of visual cells
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients that can be to understand how to test, follow exactly the instructions of the investigator
Key exclusion criteria
Patients that have turbidity such as cataract, in the middle translucent body
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiraga humio |
Organization
Okayama University Hospital
Division name
Ophthalmology
Zip code
Address
Okayama Shikata-cho, Kita-ku, 2-5-1
TEL
086-223-7151
tetuhiro1129@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuhiro Kawata |
Organization
Okayama University Hospital
Division name
Ophthalmology
Zip code
Address
Okayama Shikata-cho, Kita-ku, 2-5-1
TEL
086-223-7151
Homepage URL
tetuhiro1129@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama University Hospital
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
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
| 2014 | Year | 10 | Month | 01 | 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
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the cell morphology and cell density
Management information
Registered date
| 2014 | Year | 10 | Month | 01 | Day |
Last modified on
| 2014 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013767
