UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019334 |
|---|---|
| Receipt number | R000022358 |
| Scientific Title | The effects of fluctuation of central venous pressure on optic nerve |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2022/10/17 20:49:32 |
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Basic information
Public title
The effects of fluctuation of central venous pressure on optic nerve
Acronym
The effects of fluctuation of CVP on optic nerve
Scientific Title
The effects of fluctuation of central venous pressure on optic nerve
Scientific Title:Acronym
The effects of fluctuation of CVP on optic nerve
Region
| Japan |
Condition
Condition
single ventricle
Classification by specialty
| Cardiology | Pediatrics | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Post-Fontan syndrome of eyes
Basic objectives2
Others
Basic objectives -Others
understanding of the disease
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Having glaucoma or not
Key secondary outcomes
1.sex
2.operative method
3.family history of glaucoma
4.CVP
5.intra ocular pressure
6.visual field
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
| 10 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients from adolescents to adults those Fontan operation was enforced
Key exclusion criteria
1 patients had glaucoma surgery
2 glaucoma patients
3 patients suspected development glaucoma
4 patients whom a study person in charge judged to be inappropriate as a study subject
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinki Chin |
Organization
Hokkaido University graduate school of medicine
Division name
ophthalmology
Zip code
Address
Kita 15, Nishi7, Kita-Ku, Sapporo, Hokkaido, Japan
TEL
011-706-5944
schin@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Riki Kijima |
Organization
Hokkaido University graduate school of medicine
Division name
ophthalmology
Zip code
Address
Kita 15, Nishi7, Kita-Ku, Sapporo, Hokkaido, Japan
TEL
011-706-5944
Homepage URL
riki-k@med.hokudai.ac.jp
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
YES
Study ID_1
015-0212
Org. issuing International ID_1
Hokkaido University Hospital Clinical Research and Medical Innovation Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | 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
no 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
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 09 | Month | 30 | Day |
Other
Other related information
Prospective and retrospective case control study
2015/9/30-2022/3/31(Registration deadline2017/3/31)
Patients from adolescents to adults those were enforced Fontan operation.
They visited Hokkaido University Hospital for treatment in a pediatrics.
Evaluate of visual acuity, refraction, IOP, fundus examination, OCT, and visual field
Management information
Registered date
| 2015 | Year | 10 | Month | 13 | Day |
Last modified on
| 2022 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022358
