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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006947
Receipt No. R000008203
Scientific Title The evaluation of new device for self measuring of intraocular pressure
Date of disclosure of the study information 2012/04/01
Last modified on 2020/01/01

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Basic information
Public title The evaluation of new device for self measuring of intraocular pressure
Acronym The evaluation of new device for self measuring of intraocular pressure
Scientific Title The evaluation of new device for self measuring of intraocular pressure
Scientific Title:Acronym The evaluation of new device for self measuring of intraocular pressure
Region
Japan

Condition
Condition Glaucoma, heathy volunteers
Classification by specialty
Ophthalmology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The evaluation of accuracy and safety of new device for self measuring of intraocular pressure
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intraocular pressure, safety
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 self measuring of intraocular pressure
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1.Open angle glaucoma, Healthy volunteers
2.Subjects who sign an informed consent form to participate in the clinical study
Key exclusion criteria Subjects who a doctor in attendance declares ineligible for any reason
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Akiyasu
Middle name
Last name Kanamori
Organization Kobe University Graduate School of Medicine
Division name Ophthalmology
Zip code 6500051
Address 7-5-1,Kusunoki-cho,Chuo-ku,Kobe
TEL 0783826048
Email ganka@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Akiyasu
Middle name
Last name Kanamori
Organization Kobe University Graduate School of Medicine
Division name Ophthalmology
Zip code 6500017
Address 7-5-1, Kusunoki-cho, chuo-ku, Kobe
TEL 078-382-6048
Homepage URL
Email ganka@med.kobe-u.ac.jp

Sponsor
Institute Division of Surgery, Department of Ophthalmology, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Division of Surgery, Department of Ophthalmology, Kobe University Graduate School of Medicine
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 Kobe Univ. Dept of Ophthal,ology
Address 7-5-1,Kusunoki-cho,Chuo-ku,Kobe
Tel 078-382-6048
Email kanaaki@med.kobe-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
2012 Year 04 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
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 Open public recruiting
Date of protocol fixation
2012 Year 04 Month 01 Day
Date of IRB
2012 Year 03 Month 15 Day
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 12 Month 25 Day
Last modified on
2020 Year 01 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008203

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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