UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032067
Receipt No. R000036582
Scientific Title The relationship between glaucomatous optic neuropathy and posture-induced intraocular pressure changes
Date of disclosure of the study information 2020/12/31
Last modified on 2021/05/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The relationship between glaucomatous optic neuropathy and posture-induced intraocular pressure changes
Acronym Glaucoma and posture-induced intraocular pressure changes
Scientific Title The relationship between glaucomatous optic neuropathy and posture-induced intraocular pressure changes
Scientific Title:Acronym Glaucoma and posture-induced intraocular pressure changes
Region
Japan

Condition
Condition glaucoma patients and normal volunteers
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether intraocular pressure changes would be deeply implicated in glaucoma progression
Basic objectives2 Others
Basic objectives -Others To investigate posture-induced intraocular pressure changes after surgical intervention
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes intraocular pressure in the lateral decubitus position minus that in the sitting position
Key secondary outcomes The results from visual field and optical coherence tomography

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria glaucoma patients and normal volunteers
Key exclusion criteria cases with ocular abnormalities except glaucoma and cataract
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Sawada
Organization Gifu University Graduate School of Medicine
Division name Ophthalmology
Zip code 501-1194
Address 1-1, Yanagido, Gifu 501-1194, Japan
TEL 058-230-6288
Email sawadaa-gif@umin.ac.jp

Public contact
Name of contact person
1st name Akira
Middle name
Last name Sawada
Organization Gifu University Graduate School of Medicine
Division name Ophthalmology
Zip code 501-1194
Address 1-1, Yanagido, Gifu 501-1194, Japan
TEL 058-230-6288
Homepage URL
Email sawadaa-gif@umin.ac.jp

Sponsor
Institute Department of Ophthalmology, Gifu University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Ophthalmology, Gifu University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Gifu University Graduate School of Medicine
Address 1-1, Yanagido, Gifu 501-1194, Japan
Tel 058-230-6059
Email rinri@gifu-u.ac.jp

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
2020 Year 12 Month 31 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 Preinitiation
Date of protocol fixation
2018 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 02 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2018 Year 04 Month 02 Day
Last modified on
2021 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036582

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.