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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019334
Receipt No. 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 2015/11/17

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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
Email 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
Email riki-k@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
Email

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 Enrolling by invitation
Date of protocol fixation
2015 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2015 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022358

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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