UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028349 |
|---|---|
| Receipt number | R000032453 |
| Scientific Title | Investigation of the relation between Central serous chorioretinal disease and stress-related factors |
| Date of disclosure of the study information | 2017/07/25 |
| Last modified on | 2017/07/24 14:30:55 |
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Basic information
Public title
Investigation of the relation between Central serous chorioretinal disease and stress-related factors
Acronym
The relation between Central serous chorioretinal disease and Stress
Scientific Title
Investigation of the relation between Central serous chorioretinal disease and stress-related factors
Scientific Title:Acronym
The relation between Central serous chorioretinal disease and Stress
Region
| Japan |
Condition
Condition
Central serous chorioretinal disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relation between Central serous chorioretinal disease and Stress-related factors
Basic objectives2
Others
Basic objectives -Others
To asses the relation between stress hormone levels, and mental status and ocular parameters.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stress hormone levels
Key secondary outcomes
Background, Profile of Mood States-Brief Form Japanese Version,The Center for Epidemiologic Studies Depression Scale, Visual acuity, Choroidal thickness, Retinal thickness, Fluorescence /Indocyanine Green angiography findings.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
blood sampling
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
| 15 | years-old | < |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Pitients with central serous chorioretinopathy on fluorescein angiography (FA) and indocyanine green angiography (IA)
2) Willingness to provide written informed consent
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Gomi Fumi |
Organization
Hyogo College Of Medicine
Division name
Department of Ophthalmology
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6111
fgomi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Iwami Hisashi |
Organization
Hyogo College Of Medicine
Division name
Department of Ophthalmology
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6111
Homepage URL
hi-iwami@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College Of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 07 | Month | 25 | 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
| 2017 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 24 | Day |
Last modified on
| 2017 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032453
| 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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