UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014722 |
|---|---|
| Receipt number | R000017116 |
| Scientific Title | Morphology of retina and choroid |
| Date of disclosure of the study information | 2014/08/01 |
| Last modified on | 2020/08/10 08:48:59 |
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Basic information
Public title
Morphology of retina and choroid
Acronym
Morphology of retina and choroid
Scientific Title
Morphology of retina and choroid
Scientific Title:Acronym
Morphology of retina and choroid
Region
| Japan |
Condition
Condition
retinal diseases and healthy volunteers
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the analyzers for retinal structures in retinal diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
contrast to noise ratio
standard deviation
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those eyes with no apparent intraocular lesions. The criteria varies in subgroup analysis.
Key exclusion criteria
Those eyes with no apparent intraocular lesions. The criteria varies in subgroup analysis.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Hisatomi |
Organization
Kyushu Medical Center
Division name
Ophthalmology
Zip code
Address
1-8-1 Jigyohama, chuo-ku, Fukuoka
TEL
092-852-0700
hisatomi@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshio Hisatomi |
Organization
Kyushu Medical Center
Division name
Ophthalmology
Zip code
Address
1-8-1 Jigyohama, chuo-ku, Fukuoka
TEL
092-852-0700
Homepage URL
hisatomi@med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kyushu Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyushu 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
九州医療センター（福岡県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | 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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
To examine the repeatability and reproducibility of the OCT images of choroid and retina after image processing
Management information
Registered date
| 2014 | Year | 07 | Month | 31 | Day |
Last modified on
| 2020 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017116
