UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028968 |
|---|---|
| Receipt number | R000033144 |
| Scientific Title | Assessment of Choroidal Structure and Circulation during a single administration of coffee in healthy subjects. |
| Date of disclosure of the study information | 2017/09/05 |
| Last modified on | 2020/03/05 09:43:03 |
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Basic information
Public title
Assessment of Choroidal Structure and Circulation during a single administration of coffee in healthy subjects.
Acronym
Choroidal Structure and Circulation during a single administration of coffee
Scientific Title
Assessment of Choroidal Structure and Circulation during a single administration of coffee in healthy subjects.
Scientific Title:Acronym
Choroidal Structure and Circulation during a single administration of coffee
Region
| Japan |
Condition
Condition
Retinal and Choroidal disorder
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To asessment of choroidal structure and Circulation during a single administration of coffee
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Choroidal luminal area, stromal areas and circulation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
a single administration of coffee
Interventions/Control_2
a single administration of water
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
non-smoking individuals with no ophthalmic or systemic disorders.
Key exclusion criteria
an age of <18 years or >60 years.
high myopia defined as a refractive error (spherical equivalent) greater than -6.0 diopters or an axial length of >26.5 mm, poor quality EDI-OCT image defined as an image index of <30, abnormal EDI-OCT findings, and previous ocular surgeries.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Nagasato |
Organization
Saneikai Tsukazaki Hospital
Division name
Ophthalmology
Zip code
6711227
Address
68-1 Aboshikuwaku Himeji City Hyogo
TEL
079-272-8555
d.nagasato@tsukazaki-eye.net
Public contact
Name of contact person
| 1st name | Nagasato |
| Middle name | |
| Last name | Nagasato |
Organization
Saneikai Tsukazaki Hospital
Division name
Ophthalmology
Zip code
6711227
Address
68-1 Aboshikuwaku Himeji City Hyogo
TEL
079-272-8555
Homepage URL
d.nagasato@tsukazaki-eye.net
Sponsor or person
Institute
Saneikai Tsukazaki Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Saneikai Tsukazaki Hospital
Address
68-1 Aboshikuwaku Himeji City Hyogo
Tel
079-272-8555
d.nagasato@tsukazaki-eye.net
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
| 2017 | Year | 09 | Month | 05 | 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
49
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 02 | Day |
Last modified on
| 2020 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033144
| 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 |
