UMIN-CTR Clinical Trial

Basic information
Public title	The effects of fluctuation of central venous pressure on intraocular pressure
Acronym	The effects of fluctuation of CVP on IOP
Scientific Title	The effects of fluctuation of central venous pressure on intraocular pressure
Scientific Title:Acronym	The effects of fluctuation of CVP on IOP
Region	Japan

Condition
Condition	single ventricle
Classification by specialty	Cardiology Pediatrics Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To measure of IOP and CVP before and after the Fontan operation(including of the pulmonary artery banding and the Glenn operation)
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	IOP and CVP before and after the operations
Key secondary outcomes	sex operative method family history of glaucoma

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Infants before the Fontan operation accepted this study
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	015-0157
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 09 Month 30 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 09 Month 28 Day
Date of IRB	2015 Year 09 Month 30 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective observational study 2015/9/30-2022/3/31(Registration deadline2017/3/31) The patients before and after Fontan procedure and related procedures, those met the selection criteria. We evaluate CVP, IOP, sex, operative procedures, and family history of glaucoma.

Management information
Registered date	2015 Year 09 Month 30 Day
Last modified on	2022 Year 10 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022151