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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014722
Receipt No. R000017116
Scientific Title Morphology of retina and choroid
Date of disclosure of the study information 2014/08/01
Last modified on 2016/02/02

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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
Email 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
Email hisatomi@med.kyushu-u.ac.jp

Sponsor
Institute Kyushu Medical Center
Institute
Department

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
Email

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 Preinitiation
Date of protocol fixation
2014 Year 08 Month 27 Day
Date of IRB
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
2016 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017116

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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