UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009791 |
|---|---|
| Receipt number | R000011468 |
| Scientific Title | Choroidal hemodynamic changes during sympathetic stimulation test in patients with central serous chorioretinopathy |
| Date of disclosure of the study information | 2013/01/16 |
| Last modified on | 2013/01/28 12:34:56 |
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Basic information
Public title
Choroidal hemodynamic changes during sympathetic stimulation test in patients with central serous chorioretinopathy
Acronym
Choroidal hemodynamic changes during sympathetic stimulation test in patients with central serous chorioretinopathy
Scientific Title
Choroidal hemodynamic changes during sympathetic stimulation test in patients with central serous chorioretinopathy
Scientific Title:Acronym
Choroidal hemodynamic changes during sympathetic stimulation test in patients with central serous chorioretinopathy
Region
| Japan |
Condition
Condition
central serous chorioretinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure choroidal circulation in patients with central serous chorioretinopathy during sympathetic stimulation test and compare it with that of healthy adult volunteers.
Basic objectives2
Others
Basic objectives -Others
To examine a possibility that the abnormal choroidal circulation changes during sympathetic stimulation is the cause of the onset in patients with central serous chorioretinopathy.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Changes of choroidal circulation
Key secondary outcomes
Changes of blood pressure, intraocular pressure and ocular perfusion pressure.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
central serous chorioretinopathy patients
cold test
Interventions/Control_2
normal adult volunteers
cold test
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adult volunteers or patients with central serous chorioretinopathy who visited Department of Ophthalmology Hokkaido University Hospital.
Patients obtained voluntary documented informed consent after sufficient explanation and understanding to participate in this study.
Key exclusion criteria
Eyes with retinal vascular disease or age-related macular degeneration.
Eyes with histories of retinal photocoagulation in the past.
Eyes with myopia of -6D or more.
Subjects with a history of ischemic heart disease, hypertension and diabetes.
Subjects research manager is deemed as unsuitable.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Wataru Saito |
Organization
Hokkaido University Hospital
Division name
Department of Ophthalmology
Zip code
Address
Nishi 7, Kita 15, Kita-ku, Sapporo 060-8638, Japan
TEL
+81-11-706-5944
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Wataru Saito |
Organization
Hokkaido University Hospital
Division name
Department of Ophthalmology
Zip code
Address
Nishi 7, Kita 15, Kita-ku, Sapporo 060-8638, Japan
TEL
+81-11-706-5944
Homepage URL
Sponsor or person
Institute
Hokkaido University Hospital
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
| 2013 | Year | 01 | Month | 16 | 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 | 01 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 16 | 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
| 2013 | Year | 01 | Month | 16 | Day |
Last modified on
| 2013 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011468
